Berlinger SmartView Clinical Trial 5.4 Owner's Manual
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SmartView Clinical Trial 5.4 1 — Last update: 15 March 2023 Berlinger & Co. AG Copyright © 2023 Berlinger &amp; Co. AG Table of Contents 1. Home .................................................................................................................................................. 5 1.1. Overview .................................................................................................................................... 6 1.2. Set Up...................................................................................................................................... 10 2. Signing in......................................................................................................................................... 11 2.1. Forgot Password ...................................................................................................................... 12 2.2. Forgot Domain ......................................................................................................................... 13 2.3. Failed Login Attempts............................................................................................................... 14 2.4. Information Window.................................................................................................................. 16 3. General............................................................................................................................................. 18 3.1. Main Menu ............................................................................................................................... 19 3.2. Use of Icons ............................................................................................................................. 21 3.3. Use of Buttons ......................................................................................................................... 22 3.4. Glossary................................................................................................................................... 23 4. Locations ......................................................................................................................................... 25 4.1. Location Icons .......................................................................................................................... 29 4.2. Managing Locations ................................................................................................................. 30 4.3. Network Delivery Rate Report .................................................................................................. 35 4.4. Monitor(s)................................................................................................................................. 37 4.5. Defining a geofence for a location ............................................................................................ 39 4.6. Managing Sectors .................................................................................................................... 41 4.6.1. Sectors for Devices .......................................................................................................... 42 4.6.2. Sectors for Manual Data .................................................................................................. 55 5. Shipments ........................................................................................................................................ 66 5.1. Shipment Icons ........................................................................................................................ 69 5.2. Managing Shipments................................................................................................................ 70 5.3. Add an Event Profile to Shipment ............................................................................................. 82 5.4. Stopping a shipment................................................................................................................. 84 5.5. Creating a Milestone for Shipments.......................................................................................... 85 5.6. Shipment Relevant Time .......................................................................................................... 87 6. Devices ............................................................................................................................................ 89 6.1. Device Overview ...................................................................................................................... 90 6.1.1. CLm Doc family................................................................................................................ 91 6.1.2. Fridge-tag family .............................................................................................................. 94 6.1.3. Sendum PT 300 ............................................................................................................. 101 6.2. Device Icons .......................................................................................................................... 105 6.3. Calibration Icons .................................................................................................................... 106 6.4. Manage and modify devices ................................................................................................... 107 6.5. Device Association ................................................................................................................. 110 6.5.1. Associate a new Sensor to a Fridge-tag 2L / Fridge-tag 3 .............................................. 111 6.6. Device calibration................................................................................................................... 113 Page 2 of 218 6.7. Geofence notifications............................................................................................................ 116 6.8. Monitoring with GPS/GPRS devices ....................................................................................... 117 7. Maps............................................................................................................................................... 118 8. Reporting ....................................................................................................................................... 120 8.1. Shipment Dashboard.............................................................................................................. 121 8.1.1. Shipment Dasboard Details............................................................................................ 123 8.1.2. Shipment Dashboard Excursions ................................................................................... 124 8.1.3. Shipment Dashboard Device Usage ............................................................................... 125 8.2. Excursions ............................................................................................................................. 126 8.2.1. Excursion Icons ............................................................................................................. 129 8.2.2. Notifications about excursions........................................................................................ 130 8.2.2.1. Notification Q-Tag Excursion ................................................................................. 137 8.2.3. Acknowledge an Excursion ............................................................................................ 139 8.2.4. Document an Excursion ................................................................................................. 142 8.2.5. Close an Excursion ........................................................................................................ 144 8.2.6. Q-tag Excursions ........................................................................................................... 145 8.2.7. Excursion markers in the graph...................................................................................... 146 8.3. Audit Trail............................................................................................................................... 148 8.4. Graph View ............................................................................................................................ 150 8.5. Custom Graph........................................................................................................................ 156 8.5.1. Detail ............................................................................................................................. 159 8.5.2. Graph ............................................................................................................................ 160 8.5.3. Statistics ........................................................................................................................ 163 8.6. Shipment Analysis Report ...................................................................................................... 164 9. Configuration................................................................................................................................. 166 9.1. Carriers .................................................................................................................................. 167 9.2. Customers.............................................................................................................................. 169 9.3. Event Profiles......................................................................................................................... 172 9.4. Packing Systems.................................................................................................................... 174 9.5. Products................................................................................................................................. 177 9.6. Clinical Trial ........................................................................................................................... 182 9.6.1. TCI................................................................................................................................. 186 9.7. smartAlert Unit ....................................................................................................................... 190 10. Administration ............................................................................................................................. 192 10.1. User Management ................................................................................................................ 193 10.1.1. User Templates............................................................................................................ 194 10.1.2. Admin .......................................................................................................................... 198 10.1.3. Restricted user accounts.............................................................................................. 203 10.2. Password Policy ................................................................................................................... 204 10.3. Site Settings......................................................................................................................... 207 10.3.1. Range Settings ............................................................................................................ 208 10.3.2. Storage Conditions ...................................................................................................... 209 10.3.3. Root Causes ................................................................................................................ 210 Page 3 of 218 10.3.4. Login Security .............................................................................................................. 211 10.3.5. Email Recipients .......................................................................................................... 212 10.3.6. API............................................................................................................................... 214 11. Profile........................................................................................................................................... 216 11.1. User ..................................................................................................................................... 217 12. Sign Out ....................................................................................................................................... 218 Page 4 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 1. Home SmartView Extended Business Logic Temperature-Controlled Item Monitor specific items through the complete cold chain even when multiple activities or device associations are involved. Key deliverables: • A 3rd-party application can create and manage TCIs over API • Activity graphs are combined over the life cycle of the TCI • Overview of TCI activity history via dedicated tab • Visualization of a combined TCI activity graph provides a startto-end overview • Monitoring time statistics available for combined activities • TCI excursion information available via dedicated tab • A user can create a basic TCI PDF report Product Stability Data Get notified when temperature deviations are exceeding product-specific thresholds so that immediate actions can be taken on the drug kit level. Key deliverables: • Definition of thresholds for temperature values in up to 8 rules for products • Product stability rules can be defined as a single or as an accumulated alarm • Definition of violation notification recipients over email • User email notification when product stability data check is violated • A system can receive stability data rule violations via webhook Clinical Trial Dedicated clinical trial container for each clinical trial to ensure quick access to all Clinical trial-related information. Key deliverables: • Creation of a clinical trial container for user-defined metadata • Easy identification of clinical trial TCI associations via dedicated tab • Download PDF report related to a specific clinical trial TCI • Download PDF report or CSV file relating to all TCIs of the clinical trial Page 5 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 1.1. Overview Dashboard The SmartView home page contains a dashboard with a quick overview of the system status, provided in four main sections for two different applications. User Configuration In the upper right corner, the dropdown menu can be found under the User Name, allowing you to configure your user account. The option button in the upper right corner provides access to a number help widgets: Help Widget • Release Notes (v5.1.2) • SmartView Manual • Device Documents • eLearning • Share your feedback • Contact Support Page 6 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Quick Navigation Buttons Four quick navigation buttons are added to the upper right corner of the smartview interface. The last visited Location, Sector, Shipment and Device can be retrieved with these buttons. Dashboard of smartview For Facility Monitoring the displayed sections will be: • Locations • Active Sector Excursions For Shipment Monitoring the displayed sections will be: • Shipments • Active Shipment Excursions Note: The visibility depends on the application that SmartView is used for and on the user permission level. Page 7 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Active Sector Excursions: The Sector Excursions box provides a short overview of all active excursions related to the defined sectors. These excursions indicate alert situation in a location, e.g. the temperature in a cold room has exceeded a user-defined threshold and is still ongoing. By clicking on an individual excursion, you can navigate to the screen to view additional detail information about the excursion. Active Shipment Excursions: The Shipment Excursions box provides a quick overview of all active excursions related to shipments. These excursions indicate the alert situation during shipments, e.g. the temperature from a shipment has exceeded a user-defined threshold and is still ongoing. By clicking on an individual excursion, you can navigate to the screen to view additional detailed information about the excursion. Locations: The Locations box provides a quick overview of the network locations that are included in the SmartView Page 8 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en installation. The status of the location is provided by an icon. By clicking on an individual location, you can navigate to the detailed screen view of the location. By clicking on the “View all Locations” you will navigate to the Location Overview. Shipments: The Shipment box provides a quick overview of the latest active shipments. By clicking on an individual shipment, you can easily navigate to the screen to view detail information about the shipment. Page 9 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 1.2. Set Up How to Set Up SmartView Clinical Trial Page 10 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 2. Signing in To access the smartview web-application please start your web browser, and enter the following URL or click directly on the link below: https://smartview.berlinger.com Note: it might be that the URL is different due to user customisation. You will be redirected to the User Sign in page of smartview. To sign in, enter the appropriate Domain (personalised for your company), your Username and Password to the according fields and press the ‘Sign in’ button. Session Timeout: User will be automatically logged out of the system after 25 min. of inactivity. Note: If you are accessing smartView via a different URL, it can be that the Domain field will not be visible due to the automatic detection by smartview based on a visited URL. Page 11 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 2.1. Forgot Password You can recover your password using your email and domain (optional) in case you have forgotten your password. A password-reset link will be sent to the your email address. You can use the link within 48 hours of period before it expires, to re-set his password. If the smartview site is accessed via a private label (e.g. https://smartview.berlinger.com/login) then you do not need to provide domain information to recover the password. Click on the Forgot your password? link on the login screen which will lead you to the Forgot Your Password screen as shown in the following image: Click Send Password to recover your password again. Forgot Domain Page 12 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 2.2. Forgot Domain In case you have forgotten your Domain name click on the Forgot your domain? link shown on the login screen above. Your Email client opens and you can send an email to the Berlinger support team. You will then be provided with your domain name. In order to recover your account, enter your E-mail address and Domain name and press the ‘Recover Account’ button. An email with the instructions to reset the password will be sent. Follow the instructions in the e-mail to reset your password. >> Failed Login Attempts Page 13 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 2.3. Failed Login Attempts Your administrator hast set up the number of log in attempts for your account. After the defined number of incorrect login attempts your account will be blocked for a certain time (between 5 and 60 min.). You get also an email with the notification that your login tries have failed several times. If you have forgotten your password or your domain please refer to Forgot Password, Forgot Domain. Failed Log in Attempts documented in Audit Trail Failed Log In Attempts will also be documented in the Audit Trail. Page 14 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en >> Information Window Page 15 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 2.4. Information Window Information about upcoming updates Beside e-mail information the smartview user will be informed with a pop up window after successful log in about new releases and other important information. By clicking the “I got it” button the window will dissapear and not come again when you log in again. Page 16 of 218 Berlinger &amp; Co. AG * SmartView Clinical Trial 5.4 - 1_en If the window is just closed the information will come up again with your next log in. >> Signing in Page 17 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 3. General The topic General consits of the following content: 1 • The description of the smartview main menu, the use and meaning of icons and buttons. Page 18 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 3.1. Main Menu The following main menu items are available: • Home • Locations • Shipments • Devices • Maps • Reporting • Configuration • Administration • Profile * Not all menu options may be visible. The visibility depends on the user permission level. It is possible to hide/reveal some menu items which are not frequently used by users, by folding/ unfolding the menu. Page 19 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en >> Use of Icons Page 20 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 3.2. Use of Icons The following icons represent the major entities in the smartview application: Icon Meaning Location Network State Shipment State Device Connectivity Device Calibration Excursion Alert State Excursion User State There are also a number of clickable icons to be identified in smartview: Icon Meaning Icon providing action options View more info icon >> Use of Buttons Page 21 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 3.3. Use of Buttons The use of buttons in smartview, enables you to perform certain actions: Extract of examples for smartview buttos: Button Meaning Usability Create The create buttons allow you to create a specific entity Upload Data Files Enables you to upload one ore more data files PDF Generates the Shipment PDF report Modify Enables you to modify the details of a specific entity Delete Enables you to delete an entity Toggle filters Reveals and hides the sorting and filtering options More options Provides additional options for the page >> Main Menu Page 22 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 3.4. Glossary Shipment The process of transferring a package from A to B can be stored in a shipment. You can think of transport by plane, truck, train, etc. During this transfer, the package will be monitored by multiple devices. The connection between devices and shipments can be made with ShipmentAssociations. A shipment can have an event profile assigned to monitor any discrepancies during transit. SubShipment A sub-shipment is part of a larger shipment (master shipment) but can be used to split device monitoring/event profiling. You can, for example, have an “inside” and “outside” of a shipment, for monitoring inside a package and outside of a package. Device A monitoring device which is capable of sampling temperature, humidity, light, shock or any other parameter. The data can be retrieved in multiple ways. This can either by pushed to our servers by the device itself or manually uploaded over API or through the SmartView portal. ShipmentAssociation The link between a device and a shipment. This link contains information about the time this association was started and the time this associated ended. Any data that is coming in for that device during this period will be considered to belong to the related shipment. Milestone A marker somewhere along the process that can indicate something special happening. (In case of a shipment it could mean that a shipment arrived at some stop-over station) Event Profile A set of rules to monitor the data of the devices coming in. An event profile can be assigned to shipments and sectors. Any incoming data will be checked on the rules of the event profile. If it’s exceeding any of those rules we will create an excursion and send an alarm (by email or SMS) to the configured users. Excursion Whenever a violation of any of the defined event rules occurs we will create an excursion describing when a violation of that rule occurred. End users should take action based on these excursions by checking what is going on. After they checked they can either acknowledge or close an excursion by providing some information about what triggered this excursion and how it is resolved. Root Cause A reason for why an excursion occurred. There can be various reasons why the excursion occurred, to streamline the way that excursions can be resolved we use root causes to determine what really triggered this excursion to happen. Product A physical product that is being shipped. A product can have a set of stability rules containing alarm thresholds to determine if the product can still be used or not. This stability will be calculated against those rules, based on the samples of the connected devices (through shipment or sector associations). A product also can have storage conditions that should be met while transferring or storing this product. Those storage conditions should be seen as a global temperature range in which this product should be transferred/stored. Storage Condition A range to define between which temperatures a product should be transferred or stored. This range will be used in reports and graphs to indicate if a product has been outside of this ‘safe’ zone. Page 23 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Customer This is the customer that a shipment is made for. Location A physical location that is used to store packages. These can be depots or a clinical site. Each location consists of multiple sectors. Packages will mostly be stored for a longer time here. Sector The actual place in the location where this package is stored. There can be sectors containing different storage conditions like a very cold fridge, a cold room, and a room with ambient temperature. All those different sectors will be capable of storing and monitoring a different kind of packages. Also, these packages will be monitored by an event profile to notify about any discrepancies. SectorAssociation To be able to monitor packages in a sector we will need devices being linked to a sector. That is where the SectorAssociation is used for. In a SectorAssociation, you can define the period a device is linked to a sector. All data from the device during this period will be used to monitor that specific sector. Clinical Trial A Clinical Trial that is being handled. A clinical trial consists of multiple TCIs that are actually the packages that are being shipped or stored. TCI A TCI (Temperature Controller Item) is an item, e. g. a single product package, a bunch of products, a pallet, a container, etc. which has a unique ID and is continuously temperature monitored end-to-end throughout the cold chain. This is done by an uninterrupted tracking of the item and the associated monitoring devices throughout the cold chain. A TCI is the basis for checking continuously the temperature graph against defined product stability data. In case of Clinical Trials, a TCI can be a drugkit. TCIAssociation The link between a device and a TCI. A TCI can only be associated with one device at a time. All samples of the connected device during the associated period will be used to monitor the TCI. That means that the Product Stability Check will be run against all this data Page 24 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 4. Locations The Locations screen provides an overview of all the Locations created in the system and indicates their network status (offline or online). A Location can be: • An Origin Location for one/more Shipments • A Destination Location for one/more Shipments • A Location with a monitoring network containing one/more Sectors You can expand the bar of each particular location by clicking on the information: arrow to see additional By clicking on the Location name, you will be redirected to the View page of that particular Location. In this screen, you will find the following information: Address: address information that has been pre-defined for the Location. Sector Overview: this sector overview provides a list of all the Sectors within the Location. The status is shown for each Sector, including the value and timestamp of the most recent measurement. Summary: this section on the right side of the screen, displays the last measurement of a sensor from this location. It also shows information about the number of shipments originated/ destined to this location and number of sensors reported from the location. Page 25 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en This page also provides a number of Tabs, which enable you to perform a number of actions: Details Is the Location Overview screen Map Enables you to view the Location on the Map. Page 26 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Delivery Rates To monitor the performance of the wireless network a new Tab (Delivery Rates) to the location screen was added. The following information is shown: List of sectors, Number of devices associated with each sector. Audit Trail Redirects you to the audit trail for this specific Location. Page 27 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Monitors(s) Enables the overview of all the sectors and received values in a format which can be displayed on big screens. Page 28 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 4.1. Location Icons Icon Meaning Description Not monitored Location is not being monitored Online Offline Network at Location is on-line, which means that data is currently be received in SmartView. Network at Location is offline, which means no data received for at least one hour. Page 29 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 4.2. Managing Locations Create Location To create a Location, click on the Locations tab in the main menu. This button provides you with an overview of all the existing locations in smartview. https://player.vimeo.com/video/178154041 Click on the button and choose a name for your Location. After creating a Location, you can define optional detailed information for it, such as address, email, contact and exact position (i.e. longitude and latitude information) of the Location. Further on, if you are using SmartView for shipment monitoring, then you have the option to configure a Location to be used as an Origin and/or Destination for shipments. Note: Provide the email address of the person responsible for the Location (e.g Location Manager). If the Network Monitoring functionality is turned on for your site, the system will use the email address to notify you in case the network of the location is found offline for more than an hour. Page 30 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en If you are using the SmartView for Shipment Monitoring then you will see the Shipment Settings section in the Edit Location screen (as shown in the above image). This section allows you to mark a Location for the usage of Origin and/or Destination. If you want a Location to be used as Origins of Shipment then check the box Use as Origin. If you want a Location to be used as Destinations of Shipment then check the box Use as Destination. To use a Location for Origins and Destinations then check both of the options. Modify Location To modify a Location, click on the Modify button in the right corner. You can modify the following fields as shown on the screenshot. Page 31 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Enable/Disable Location If you want to enable or disable a location use the toggle Enable/Disable on the bottom of the details tab in modify mode. Choose to modify in the location tab. Scroll down to the toggle Enable/Disable and change settings. Page 32 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 33 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Click save to save your settings. ! A Location cannot be deleted, only disabled. Page 34 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 4.3. Network Delivery Rate Report To monitor the performance of the wireless network a new Tab (Delivery Rates) to the location screen was added. The following information are shown: • List of sectors • Number of devices associacted to each sector Per device the following information will be shown on a weekly basis for the last 4 weeks: • Number of messages received • Delivery rate in percent (%) Measruements and Delivery rate Quality color indicators The background per cell in this table will be colour-code, either green, orange, or red. Page 35 of 218 Berlinger &amp; Co. AG * SmartView Clinical Trial 5.4 - 1_en The functionality will only be available for Locations that are monitored with a network. Page 36 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 4.4. Monitor(s) If you click on Monitor(s) you have a visual overview of all sectors within a location by color coding the individual tiles. This view is opened in a separate window, that it can easily be shown on an external (second Screen) for monitoring purposes. Color Status green actual temperature wihtin set limits red actual temperature outside set limits Display yellow Sector offline Temperature Monitor Description Page 37 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en • The figures of the big letters (in this example 4.25°C and 8.12°C) show the minimum and the maximum measured temperature over the last 24 hours. • The small figures above (actual) show the minimum (4.24°C) and the maximum (8.12°C) measured temperature of the last timestamp. • The last sample indication shows the temperature of the most recent device, which is in this example 6.19°C. Page 38 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 4.5. Defining a geofence for a location You can specify a geofence for a Location. Specifying geofence for a Location will allow you to get notification emails for a Shipment if its associated GPS enabled sensor (e.g.Sendum) is found to be arrived within the geofence area of the Location. Thus this functionality allows you to receive notification about a Shipment Departure from a Location and Arrival in a Location. https://player.vimeo.com/video/176163701 To define the geofence for a location go to the Location menu item and click on the and then click on the Map tab. button Page 39 of 218 Berlinger &amp; Co. AG * SmartView Clinical Trial 5.4 - 1_en If you have defined your address already under the tab General the Latitude and Longitude will be filled out by clicking the Autolocation button. Click on the Geofence button. The screen will show the map with location icon to which you can interact with to specify the geofence. You can define the geofence as a circular area around the location. Use the Left-click of the mouse to define the geofence in the map. As shown in the following image a circular geofence will be shown around the Location and radius of the circle will be shown in the Radius field. You can use the Right-click of the mouse to undefined the selected geofence and redefine the geofence. Once you have defined the right geofence click on the Save button to save the changes. Page 40 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 4.6. Managing Sectors Sectors can be created as as one of 2 different types. First are Sectors for Devices and second are Sectors for Manual Data. Page 41 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 4.6.1. Sectors for Devices Create a Sector for devices https://player.vimeo.com/video/177224532 To create a Sector, click on the Create Sector button in the Location: Choose a name for your Sector and/or a description and click ok: Page 42 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Modify Storage Conditions You can choose a Storage Condition for your sector which you have predefined under Site Settings / Storage Conditions. Add a Device Association to a Sector Choose the Sensors that you would like to Associate to the Sector, by clicking on the Associations Tab – then click on the Create Association button: Page 43 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en https://player.vimeo.com/video/178156803 After creating a sector, you can associate a Device to it by clicking on the shown in the following image: as Click in the Serial No. field to choose your Device for the Sector. Page 44 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Select or modify the Start Date and click on You can repeat this process for as many Devices as you would like to add to your Sector. Add an Event Profile to Sector Page 45 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en https://player.vimeo.com/video/177236014 Before adding an Event Profile to the sector, make sure you have created a profile with appropriate event rules. Adding an Event Profile to a Sector can be done from the Modify screen of the Sector. Click on the “Event” tab in the Modify screen: Click on the Monitoring button to enable Event Monitoring and select “created”: Event Profile from the dropdown list: Page 46 of 218 Berlinger &amp; Co. AG Click on SmartView Clinical Trial 5.4 - 1_en to save your changes. Notification if the network is offline The Customer (Site Contact) will receive a notification in any case if the network is offline for more than 60 minutes. If the notification is turned on by default it cannot be changed in the backend of SmartView. Please contact [email protected] if you want to turn OFF/ON network notification at all. Add a Notification for a Location If a Sector of a Location is offline the contact person of the location will be notified per Mail (eg. people on site) Page 47 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en You can modify users (add and remove) on the right by pressing the button to modify. Add or remove Users from the notification list Page 48 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Notification for a sector When sector offline monitoring is enabled SmartView will send e-mail notifications to SmartView users. This functionality can be configured for each sector, including time interval and recipients. Press Modify on the right. NOTE: Users have to set up these notifications for their Sectors to benefit from this functionality. Notification for a device When no device measurements are received from the sector for the user-defined period. This functionality can be configured for each sector, including time interval and recipients. Page 49 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en The notification for devices can be set ON or OFF. If it is ON the notification will be sent to the user-defined above within the notification recipients. Location User question mark – This user(s) will be used for the location offline/online notifications. Modify a Sector If you want to change entries in a Sector, click Modify on the right side. You can modify all entries which you have put in when creating the Sector. Page 50 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Reason for change If the “Reason for Change” has been enabled by the Admin in the site settings then all changes made to sectors will require the user to provide the reason for the change. This information will be visible in the Audit Trail. Enable/Disable a Sector If you want to enable or disable a sector use the toggle Enable/Disable on the bottom of the details tab in modify mode. Choose to modify in the sector tab Page 51 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Scroll down to the toggle Enable/Disable and change settings. Page 52 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 53 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Click save to save your settings. ! A Sector cannot be deleted, only disabled. Page 54 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 4.6.2. Sectors for Manual Data Create a Sector Manual Data ! Setting up the sector for Manual Data entries can not be undone Enter the Location in which you which you wish to create a new sector.There on the top right corner the Create Sector button can be found. To create a Sector, click on the Create Sector button: Choose a name for your Sector, a description(optional) and select Manual Data, then click ok: Modify Storage Conditions Page 55 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en You can choose a Storage Condition for your sector which you have predefined under Site Settings / Storage Conditions. Associations to a Sector The system will automatically generate a virtual device for the sector. It’s not possible to conduct any changes in the associations tab of the sector settings. Add an Event Profile to Sector Page 56 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en https://player.vimeo.com/video/177236014 https://player.vimeo.com/video/177236014 Before adding an Event Profile to the sector, make sure you have created a profile with appropriate event rules. Adding an Event Profile to a Sector can be done from the Modify screen of the Sector. Click on the “Event” tab in the Modify screen: Click on the Monitoring button to enable Event Monitoring and select “created”: Event Profile from the dropdown list: Page 57 of 218 Berlinger &amp; Co. AG Click on SmartView Clinical Trial 5.4 - 1_en to save your changes. General view of the sector For the manual data sector a new tab will be visible with the name measurements. In this tab the manual added data will be listed in a table with one of 3 different states. The 3 different states are as follow: State Meaning Pending Data was entered Approved/declined Data was peer reviewed Page 58 of 218 Berlinger &amp; Co. AG Processed SmartView Clinical Trial 5.4 - 1_en Data handled by Smartview Also visible in the table is the user responsible for the last change of state. Information of all changes with the responsible users can be found in the PDF report for the sector. * Items are marked per default as pending data and have to be approved before the system can handle them. Only approved data is processed. Adding manual data A Manual data entry can be created on the right side of the measurement window Approving/declining Data ! The approval of the data has to be done in chronological order. ! The data has to be approved before it can be used by the system. The entered data can be approved on the bottom left side of the measurement window. Page 59 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en After selecting the action a popup will confirm if the action as successful Notification if the network is offline The Customer (Site Contact) will receive a notification in any case if the network is offline for more than 60 minutes. If the notification is turned on by default it cannot be changed in the back-end of SmartView. Please contact [email protected] if you want to turn OFF/ON network notification at all. Add a Notification for a Location If a Sector of a Location is offline the contact person of the location will be notified per Mail (eg. people on site) Page 60 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en You can modify users (add and remove) on the right by pressing the button to modify. Add or remove Users from the notification list Page 61 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Notification for a sector When sector offline monitoring is enabled SmartView will send e-mail notifications to SmartView users. This functionality can be configured for each sector, including time interval and recipients. Press Modify on the right. NOTE: Users have to set up these notifications for their Sectors to benefit from this functionality. Notification for a device When no device measurements are received from the sector for the user-defined period. This functionality can be configured for each sector, including time interval and recipients. Page 62 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en The notification for devices can be set ON or OFF. If it is ON the notification will be sent to the user-defined above within the notification recipients. Location User question mark – This user(s) will be used for the location offline/online notifications. Modify a Sector If you want to change entries in a Sector, click Modify on the right side. You can modify all entries which you have put in when creating the Sector. Page 63 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Reason for change If the “Reason for Change” has been enabled by the Admin in the site settings then all changes made to sectors will require the user to provide the reason for the change. This information will be visible in the Audit Trail. Enable/Disable a Sector If you want to enable or disable a sector use the toggle Enable/Disable on the bottom of the details tab in modify mode. Choose to modify in the sector tab Page 64 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Scroll down to the toggle Enable/Disable and change settings. Click save to save your settings. ! A Sector cannot be deleted, only disabled. Page 65 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 5. Shipments The Shipments page provides an overview of all the Shipments is SmartView: active, pending, idle or completed. The Overview list also contains details about the Shipment, such as Shipment ID, Product, Origin, Destination, etc.) You can “create a shipment” and take “More Actions” like export the list to CSV or Add to Analysis (one or more Shipments must be selected) Create a Shipment Analysis Report: Shipment Filters Go to Shipment overview and choose AIR as a transport method and the following list will appear: Page 66 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 67 of 218 Berlinger &amp; Co. AG * SmartView Clinical Trial 5.4 - 1_en Their are two additional filters like Flight Code and Flight Date, compared to all other transport methods. Page 68 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 5.1. Shipment Icons Idle Newly created shipments Pending Shipments with associations waiting for data Active Shipments with (partial data) Completed Shipments with all data accounted for Expired Shipments that did not send in all data in time Approved Manually approved shipment Declined Manually declined shipments Archived Manually archived shipments Page 69 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 5.2. Managing Shipments Shipment Overview Page Page 70 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Create a Shipment https://player.vimeo.com/video/175370241 From the Shipment Overview page, click on to add your Shipment. This will open a pop up as illustrated below, allowing you to choose a Shipment ID for your Shipment: Page 71 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Note: If you have created similar Shipments in the past, you also have the option to choose a template for your new Shipment out of the existing ones. Once you have chosen the Shipment ID, click OK and you will be redirected to the screen, allowing you to choose the detailed information for your Shipment. Note: Alternatively, you can add information at a later stage by clicking on the Modify button of a shipment. You can add following information to the shipment: General settings about the shipment: In this section you can edit the Name (i.e. Unique Shipment Identifier) of the Shipment and optionally can add a descriptive note to the Shipment. You can also define the Customer of the Shipment by selecting one from a drop-down list. . Page 72 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Transportation information of the shipment: In this section you can define origin, destination, trip ID, transport Method, transportation Company and Carrier of the shipment. Origin, destination and transport Method need to be selected from their drop-down lists. If Method is selected as Air then Carrier field will show a drop-down list with Air Carrier subset list that is already defined in the system. For other transport Method (e.g. Road) Carrier field will become a free-text field and will allow you to type the name of the carrier. Product information for the shipment: In this section you can choose the predefined product for the shipment. If a Product Code is defined for the product, then selecting the product, will populate the Product Code filled in the screen. Optionally you can define related Batch Number and Order number. Note: Before you start creating a Shipment and defining its detailed information, make sure you have already defined and/ or configured the following information • Customer • Location (to be defined as Origin / Destination) • Product • Air Carrier subset list • Also note that you may not be able to delete an item (e.g. customer or product) if it has once used with a Shipment. After defining the General Information for your Shipment, you need to associate the necessary devices to the Shipment: Click in the Serial No. field to choose your Device for the Sector. Page 73 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Select or modify the Start Date and click on After associating the devices, you need to enable the Event monitoring for the Shipment by choosing an existing Event Profile. This will enable SmartView to apply the appropriate rules, and notify you in case of an excursion event. You can access the Event page by clicking on the Event tab: Click on the Monitoring button, to enable the Event Monitoring: Page 74 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Once this has been enabled, you can choose the appropriate Event Profile from the drop down list: Note: If you cannot find the necessary Event Profile in the list, you can define a new Event Profile by following the steps in chapter Event Profiles. By selecting the Event Profile in the drop down list, the Event Profile will be applied to your Shipment. Click on Save to save your changes. Page 75 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Add a Device Association to a Shipment After creating a Shipment, you need to associate one/more devices to it. https://player.vimeo.com/video/176303737 You can also add devices to an existing Shipment which has not been started yet. Page 76 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Unit Load Device You can add one or multiple unit load device ids to the device association. Commisson Number You can add one or more commisson numbers to the device association. Modify a Shipment The Modify Shipment screen can be accessed in two ways: 1. From the Options button in the Shipment Overview page, choose Modify Shipment. Page 77 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 1. By clicking on a Shipment in the Shipment Overview page, you will be redirected to the View Shipment page. Click on Modify button to add an Association. Add an Event Profile to a Shipment https://player.vimeo.com/video/175365680 To add an Event Profile to the Shipment, click on the “Event” tab in the Modify screen of the Shipment: Page 78 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Click on the Monitoring button, to enable the Event Monitoring: From the dropdown list, select the Event Profile which you have created. Click on to save your Event Profile to this Shipment. Add a Milestone to a Shipment SmartView allows a user to document a useful information related to a specific shipment by allowing the Page 79 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en user to add a milestone to the shipment. For example, to document the arrival of a shipment to a location, a user can add a milestone “Shipment arrived at location X” with the time stamp of the arrival. https://player.vimeo.com/video/176302328 To create a milestone go to the Shipment and click on the button. Under this tab you can see all the milestones related to this shipment that have already been defined or add new Milestones if necessary. • Select the date and time of the milestone in the Date field Page 80 of 218 Berlinger &amp; Co. AG • Provide a short description for the milestone and click the SmartView Clinical Trial 5.4 - 1_en button. You can visualise your milestones both on the Shipment Graph and on the Shipment PDF report. Delete a Shipment You cannot delete a shipment! Page 81 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 5.3. Add an Event Profile to Shipment https://player.vimeo.com/video/175365680 https://player.vimeo.com/video/175365680 To add an Event Profile to the Shipment, click on the “Event” tab in the Modify screen of the Shipment: Click on the Monitoring button, to enable the Event Monitoring: From the dropdown list, select the Event Profile which you have created. Page 82 of 218 Berlinger &amp; Co. AG Click on SmartView Clinical Trial 5.4 - 1_en to save your Event Profile to this Shipment. Note: Here you can change who should be notified by our system in case of an alarm. Page 83 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 5.4. Stopping a shipment A shipment that is monitored by wireless sensors should be stopped in order to make use only of the relevant data related to the shipment. Stopping a shipment automatically disassociates all Smart Sensors from a shipment and also creates the final shipment report. Note: Stopping a shipment is not possible for shipments with an associated Q-tag. As the start time and stop time of such shipments is determined based on the start and stop time of the associated Q-tag data files uploaded by the user, it is not possible for a user to define the start and stop for such a shipment. The information will be derived automatically from the devices. The shipment can be stopped from the View screen of the individual shipment, by clicking on the button. The shipment is stopped in two steps: Enter the stop time (this indicates the moment that the wireless devices or GPS/GPRS devices are removed from the shipment). Press the OK button. Note: To support the reliability of this procedure, the system only allows a stop-time that is close to the current system time (based on a user-defined allowed time frame). Note: Idle shipments can be stopped. Page 84 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 5.5. Creating a Milestone for Shipments SmartView allows a user to document a useful information related to a specific shipment by allowing the user to add a milestone to the shipment. For example, to document the arrival of a shipment to a location, a user can add a milestone “Shipment arrived at location X” with the time stamp of the arrival. https://player.vimeo.com/video/176302328 https://player.vimeo.com/video/176302328 To create a milestone go to the Shipment and click on the button. Under this tab you can see all the milestones related to this shipment that have already been defined or add new Milestones if necessary. Page 85 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en • Select the date and time of the milestone in the Date field • Provide a short description for the milestone and click the button. You can visualise your milestones both on the Shipment Graph and on the Shipment PDF report. Page 86 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 5.6. Shipment Relevant Time In certain cases you may want to modify the relevant time of a Shipment. This may be, due to fact that one or more associated sensors were started earlier or stopped later than the actual start or stop time of a shipment. Rather than modifying each of the sensor timestamp, SmartView allows you to define the correct time by setting a relevant time to the Shipment. https://player.vimeo.com/video/178443573 Modify Relevant Time This option can be accessed by clicking on in the Shipment Graph. As shown in the following screen, you will asked to confirm your action to access the option to modify the relevant time of the Shipment. Page 87 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Click on OK to continue access to modify the Shipment relevant time and follow the following steps: Select Modified Time: Click Start time or Stop time button for the time that you want to modify. You can define the time in the Modified time box. You can select the modified time for both Start and Stop time or for either of them. After you have chosen the time, like shown in the following image, the screen will show grey coloured background for the trimmed part of the data due to the modification. You can click on the Clear button to deselect the chosen modified time and reselect the time again. If you do not wish to modify the time click on the Cancel button and you will return to original graph screen. Note: When modifying relevant time may affect the excursion information. Page 88 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6. Devices The type of devices supported by SmartView: • Wireless active RFID sensors. The SmartPoints and the AiroSensors can be employed as wireless sensors for static monitoring and can be used for RF Data Logging applications. These sensors use wireless networks to automatically forward data to the SmartView application. • Q-tag CLm Doc family. Users can utilize the Q-tag CLm Doc to log temperature measurements during a shipment. The SmartView system supports different types of Q-tag devices like Dry Ice (D), Logger (L) and Reusable ®. When the Q-tag data file is uploaded into the SmartView system, users can use SmartView to view detailed information regarding the measurements of the shipment. In addition, users can benefit from the reporting and analysis functionalities of SmartView. • Fridge-tag family. Users can utilize the Fridge-tag 2 L to log temperature measurements at different locations or during a shipment. The SmartView system supports the Fridge-tag 2 L. When the data file is uploaded into the smartview system, users can use smartview to view detailed information regarding the measurements of the monitored goods. In addition, users can benefit from the reporting and analysis functionalities of SmartView. By integrating our Fridge-tag 3 devices into SmartView we offer the best of two worlds: Having a stand alone device which is sending out alarms by SMS directly to defined recipients, and in parallel reporting to SmartView providing access to all relevant functionality of our data management software. • Fridge-tag 2 L • Fridge-tag 3 • GPS/GPRS monitoring devices. Sendum PT300 is a GPRS monitoring device that can be placed either on packages during shipments in order to create real-time in-transit visibility or in temperature-controlled transportation vehicles. • Sendum PT300 Page 89 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6.1. Device Overview The device overview shows all devices in use with their current information. Page 90 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6.1.1. CLm Doc family Supported Devices by SmartView are: • Q-tag CLm doc • Q-tag CLm doc L (Logger) • Q-tag CLm doc LR (Reusable) • Q-tag CLm doc Ice (Logger) • Q-tag CLm doc Ice R (Reusable) • Q-tag CLm doc D (Dry Ice) Uploading CLm doc data files Note : Before you upload a CLm doc data file make sure the CLm doc device is already registered for your site. If the device has not been registered to your site you cannot upload the data file. To upload a new CLm doc data file in the system go to the menu item “Devices” and click on the button. https://player.vimeo.com/video/232785719 Page 91 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en The following screen will appear, allowing you to choose the Clm doc files which you would like to upload: Uploading a CLm doc file is a three step process. Step 1: Select File(s). Choose Q-tag file(s) and click the Upload File(s) button. Step 2: Check File(s). After the Q-tag data files are uploaded, in the second step the system will check the integrity of the files. You will be notified if any file is invalid or its integrity has been compromised or if the file has been uploaded to the system earlier. Step 3: Process Files. Finally click the button to store the Q-tag data into the Page 92 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en system. If any Q-tag device ID does not exist in the system, this process will also ensure the inclusion of the Q-tag device ID in the system. If the Q-tag devices are already associated with any shipment, this process will also make an update in the shipment information such as filling the start time of the shipment. After the files are processed, the results will be shown in the Results section. You will be notified about how many of the files have been processed and how many of them are ignored. CLm doc family e-mail data upload Watch the video to see how the Clm doc family data files are sent by E-mail to smartview. The e-mail address for the e-mail data upload is [email protected]. https://player.vimeo.com/video/206205338 Page 93 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6.1.2. Fridge-tag family Supported Devices by SmartView are: • Fridge-tag 3 • Fridge-tag 2 L Fridge-tag 3 Key-Features Fridge-tag 3 • Temperature data is shown in a Graph • Fridge-tag 3 devices can be associated to Sectors • Temperature and non-temperature related events from the device are converted to Notifications in SmartView • Daily Statistics are stored in SmartView and can be viewed and exported as PDF • Device Event notifications are stored in SmartView • Two different Email Recipient lists are available: one for the temperature related Notifications and another one for non-temperature related Notifications • Excursions from the device are converted to Excursions in SmartView when the device is associated to a Sector • Sector and Device offline Notifications are supported when the Device is associated to a Sector • Full support of the SmartView Excursion management and tracking • Full support of the SmartView Audit Trail • Device can be configured in SmartView, allowing the user to change all relevant Settings • Configurations can be saved as Templates for easy assignment to multiple Devices Page 94 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Fridge-Tag 3 Configuration Fridge-Tag 3 General Information Page 95 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en • Firmware version • GSM module version • IMEI • Mobile number • Mobile gateway • SIM ID • Device model • Initial CID • Timezone Fridge-tag 2 L Key-Features Fridge-tag 2 L • • • • • Log temperature measurements at different locations or during a shipment. Upload to SmartView manually Status Checks of the device are shown in the column of the daily statistics Device time zone is now integrated in PDF reports Data gaps are now shown in the PDF report as “-“, when including the measurements The Fridge-tag 2 L measures the ambient temperature. If one of the two alarm limits is exceeded or fallen below, an alarm will be triggered on the display and/or is audible as an audio signal. A quick decision and immediate action is thus possible. The PDF/A report, now also with a temperature curve, can be generated without additional software. The Fridge-tag 2 L is optionally available with an external temperature sensor (measures till –40°C / –40°F) Page 96 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Uploading Fridge-tag 2 L data files Note : Before you upload a Fridge-tag 2 L data file make sure the Fridge-tag 2 L is already registered for your site. If the device has not been registered to your site you cannot upload the Fridge-tag 2 L data file. To upload a new Fridge-tag 2 L data file in the system go to the menu item “Devices” and click on the Page 97 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en The following screen will appear, allowing you to choose the Fridge-tag 2 L files which you would like to upload: Uploading a Fridge-tag 2 L file is a four step process. Step 1: Select File(s). Choose Fridge-tag 2 L file(s) and click the Upload File(s) button. You can upload serveral files at one time, but only one file per device. Page 98 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Step 2: Check File(s). After the Fridge-tag 2 L data files are uploaded, in the second step the system will check the integrity of the files. You will be notified if any file is invalid or its integrity has been compromised or if the file has been uploaded to the system earlier. Step 3: Process Files. Finally click the button to store the Fridge-tag 2 L data into the system. If any Fridge-tag 2 L device ID does not exist in the system, this process will also ensure the inclusion of the Fridge-tag 2 L device ID in the system. If the Fridge-tag 2 L devices are already associated with any shipment, this process will also make an update in the shipment information such as filling the start time of the shipment. After the files are processed, the results will be shown in the results section. You will be notified about how many of the files have been processed and how many of them are ignored. Step 4: Select Timezone. The timezone can be selected when uploading the file. Last setting will be Page 99 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en stored as a default, no need to choose the timezone everytime when uploading. To be sure that you have chosen the right timezone you have to confirm the timezone with “ok”. Page 100 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6.1.3. Sendum PT 300 The Sendum PT300 Functions With the Sendum the following measurements can be tracked in smartview: Page 101 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Sensors • Temperature • Humidity • Battery Voltage • Air Pressure • Light intensity • RF Strength • Tilt • Battery percentage • Shock force Configuration Settings Page 102 of 218 Berlinger &amp; Co. AG * SmartView Clinical Trial 5.4 - 1_en You can see all configuration settings of the Sendum in SmartView. Changes in the configuration can not be made within SmartView. Please contact our support team [email protected] to help you configuring the Sendum in the right way. Modifications in SmartView Modification can be made for: • • • • State: enabled or disabled Responsible Location: e.g. Amersfoort (This is the home base of the device) Name of the Device: for e.g. Sendum #1 Description: e.g. when was the device added to the system Page 103 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 104 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6.2. Device Icons Icon Meaning Description Q-Tag device No log files have been uploaded yet. Q-Tag device The log files have been uploaded. Wireless device The device has reported within the last hour. Wireless device The device has reported within the last 24 hours. Wireless device The device has not reported in more than 24 hours. GPS/GPRS device The device has reported in the last hour. GPS/GPRS device The device has reported within the last 24 hours. GPS/GPRS device The device has not reported in more than 24 hours. Page 105 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6.3. Calibration Icons Icon Description Calibration certificate available. Calibration certificate is about to expire. Calibration has expired. No calibration certificate available. Page 106 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6.4. Manage and modify devices https://player.vimeo.com/video/178596638 The modify screen of a device, enables you to edit certain settings of a specific sensor: • • • • State: enabled, disabled or out of service Responsible location. Name: a meaningful description that can be used to identify the sensor device. Description Page 107 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Changing the state of a sensor Devices have a default status of ‘Enabled’. The status can be changed to ‘Disabled’ or to ‘Out of Service’. *Status disabled:** This supports situations where sensors should not be used temporarily in sectors or shipments anymore., Incoming data will still be processed and is available on the device level. For example assumed malfunctioning or expired calibration certification. The status can be switched back to enable at any time. . To disable a device simply click on the device, then click on to change the state. *Status out of service for SmartPoint devices only:** With this state, the device is no longer assigned to the site, incoming data will be rejected. All existing data of the device is still available. This is useful if a device is lost or shouldn`t be used anymore. By setting the state to Out of Service the device is no longer considered for the invoicing accordingly to the SLA agreement. This process cannot be reversed. ! Status “Out of Service” for SmartPoint devices only Assigning a Responsible Location A Responsible Location is a location within a corporate organization that bears the responsibility for a specific device. The location may be a location with a wireless network, but may also be a location where shipments originate, but no wireless network is available. To improve the management of a pool of devices within a corporate organisation, it is possible to assign the responsible location. To assign a responsible location, access the modify page of the device and select the Responsible Location from the list. Note: the Responsible Location will be automatically overwritten by the system with the current network location, when the device starts to report from a network location that is different from the manually assigned location. Choosing a Name Assigning a name to a device, helps the user recognise it easier in the system. The name will appear Page 108 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en throughout the system and its changes are are also reflected throughout the system. Define the Name in the Name field and click ‘Save’ to save the change. Assigning a descriptive note Besides the alias, you can also define a descriptive note for a device. Page 109 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6.5. Device Association To monitor a sector or a shipment, the specific devices need to be associated accordingly. Therefore you can: 1. Add an Association to a Shipment 2. Add an Association to a Sector 3. Associate an external Sensor to a Fridge-tag 2 / Fridge-tag 3 Page 110 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6.5.1. Associate a new Sensor to a Fridgetag 2L / Fridge-tag 3 External Sensor for Fridge-tag 2L / Fridge-tag 3 can be associate to the device. Choose the Fridge-tag 2l / Fridge-tag 3 to assign a new sensor: Select Select Replaceable Sensor: Add Replaceable Sensor by choosing the Sensor Set start date and time Page 111 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Add additional information at Association Details if available Page 112 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6.6. Device calibration The status of the calibration of each device in SmartView, can be identified in the device overview page in the column indicating a calibration icon. When hovering over with the mouse, the information box will indicate the state of the calibration of the device and whether this is available. https://player.vimeo.com/video/178598225 The different states of the calibration certificates in the device overview page are indicated as follows: Icon Description Calibration certificate available. Calibration certificate is about to expire. Calibration has expired. No calibration certificate available. The calibration of the devices can be checked also in the view page of each individual device, where it is also possible to download the certificate (if available) in PDF. In this box, you will find all the details related to the calibration, including expiration date or remaining date until this will expire. Page 113 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en E.g. Calibration certificate: Calibration Certificate Expiry Notification: All devices are part to the calibration certificate expiry notification: SmartPoint, SmartPoint One, Fridge-tag 2 L, Fridge-tag 3 Page 114 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en End-of-life Calibration If the device is no longer in use and an End-of-Life calibration was conducted the Calibration status will show a green icon with not expiry date. Page 115 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6.7. Geofence notifications If you are using a GPS enabled Smart Sensor for your Shipment and want to ensure receiving notification email, then check and ensure the following steps: Configure geofence(s) for the Location(s): SmartView will send Shipment notifications based on the detection of a GPS enabled Smart Sensor inside or outside of a geofence defined for a Location. For example, if a sensor sends position information from within the geofence of a Location for the first time, SmartView will translate the Shipment’s entry in that Location and will send notification email. In the same way SmartView will detect the Shipments exit from the Location and will send notification email. E.g. Notification E-Mail when Shipment has left Location: If you want to get notification email for a Location, you have to make sure that the Location is defined in the SmartView with geofence specified for it (see section 9.3 for detail). Main Recipients of the Shipment Event Settings: SmartView will use the main recipient of the Shipment Event Settings to send automatic notification emails. Before you add an Event Profile to a Shipment make sure that required recipients are defined. Page 116 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 6.8. Monitoring with GPS/GPRS devices The GPS/GPRS devices are autonomous battery-powered device for real-time monitoring of valuable shipments and transportation vehicles via the GSM network. The device contains a range of sensors, including temperature, humidity, battery Voltage, air pressure, light intensity, RF-strength, tilt, battery percentage and shock-force. The device also enables localisation of shipments with GPS and cellular localisation. The Sendum PT 300 automatically shuts off prior to aircraft take-off, and automatically turns back on when the aircraft lands. While in-flight, the device continues to collect sensor data. Because of the device’s capabilities to transmit the GPS location, it is also possible in smartview to draw a geofence around a location. Once the GPS/GPRS device will be associated to a shipment and once this will enter/leave the area that the geofence was defined, it will trigger an alarm and notify all the recipients defined in the event profile. Page 117 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 7. Maps You will find an overview of all destinations which you have set up as Loocation/Destination on the Map. If you click at one of the icons green, red or grey one you will get more detailed information about the device, like coordinates, status, type of device, etc. Page 118 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 119 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8. Reporting The SmartView application provides a number of reporting and analytical functionalities that enable users to review and analyze sensor data collected from their monitoring devices which are used both for shipment monitoring and for facility monitoring. The analytics and reporting module incorporates a number of functionalities which ensure the accessibility to the sensor data, provides aggregated information on the monitored shipments and enables personalized analysis depending on the required scope. A description of their usability is displayed in the following table: How to Description How to create How to use Report for each individual Shipment. Includes Automatically Evaluate the complete On-line or temperature graph, excursion information and milestones. created for each Shipment information about an individual Shipment in PDF format. Custom graph Report that combines data from multiple sensors (e.g. Q-tag CLm doc) Manually, by selecting specific sensors For specific tests such as Thermal Mappings. Online or in PDF format. Shipment Analysis Report Report that provides a statistical analysis and overlay of multiple Shipments (maximum 20) Manual, by selecting specific Shipments or directly from the View:Shipments For example to analyze the performance on a specific shipping lane or from a specific transportation company On-line or in PDF, JPG or Excel format Automatic For trend analysis, for example on the number of Shipments with excursions. Online and by e-mail subscription Shipment Report Aggregated information Shipment about excursions, Dashboard transportation and the monitoring process share The reporting and analytics module provides a powerful tool that enables users to review the automatic generated sensor data and to perform custom analysis. This module is divided in four main functionalities which outputs have been described above and which can be used both for shipment and facility monitoring. Page 120 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.1. Shipment Dashboard The Shipment Dashboard offers aggregated information about excursions, transportation and the monitoring process. The dashboard is generated automatically and moreover it is also possible to receive monthly subscriptions by e-mail. The dashboard enables trend analysis like for example on shipments with excursions on a specific trade lane. https://player.vimeo.com/video/178026101 Usability The Shipment Dashboard provides statistical information based on different entities: a) Excursions: statistical report of the excursions that have been identified based on selected time frames. b) Details: overview of all the shipments that have been monitored and statistical analysis of the information related to the shipments (such as origin, destination, customer, products) based on a selected time frame. c) Device usage: statistics based on the used monitoring devices and the information related to their use. Page 121 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Tip: You have the option in SmartView to automatically receive a monthly update of the Shipment Dashboard by e-mail. You can subscribe as follows: Navigate in the menu to Profile —> Support User and click to Subscriptions. Make a tick at the Transport Report. Page 122 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.1.1. Shipment Dasboard Details Shipment Dashboard Details • Shipment Transport Methods • Number of Shipments by Origin • Number of Shipments by Destination • Number of Shipments by Product • Number of Shipments by Product Filter by • Year • Month • Customer • Origin • Destination Page 123 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.1.2. Shipment Dashboard Excursions Shipment Excursions Dashboard • Shipment Excursions • Excursions by Root Cause • Shipment Excursions Rate • Excursions by Product Filter by • • • • • Year Month Customer Origin Destination Page 124 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.1.3. Shipment Dashboard Device Usage Shipment Excursions Dashboard • Shipped Q-tag CLm doc Upload Completion • Shipped Q-tag CLm doc Upload Completion Rate • Q-tag CLm doc Deviation • Used Loggers Filter by • Year • Month • Customer • Origin • Destination Page 125 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.2. Excursions An important functionality of smartview® is the excursion management, as the application not only documents the event excursion, but also enables you to investigate and process an the excursion. As soon as an event excursion is identified, smartview will send out notification messages to pre-defined recipients and it is important that the excursion is evaluated, acknowledged and eventually closed. A user can view all the historical excursions reported against a Shipment or a Sector. Further on it is possible for a user to note down the Root Cause and Action taken for an event excursion. This helps users to identify the most frequent causes and the user can define preventive action for identified causes. It is also possible for the users to acknowledge an Event Excursion so that the system stops sending a notification message for an excursion. After acknowledging an excursion, the user can close the excursion to indicate the proper handling of the situation. Viewing Excursion overview To view the list of all the event excursions reported by the system, click on the ‘Excursions’ tab in the Main Menu. A list will appear, displaying all the excursions registered in the system. The Home Page shows the 5 latest active shipments for both shipments and sectors. If any of the latest 8 shipments have an active excursion, then this is indicated by the excursions list found in the Home Page. icon in the The following image gives an overview of all excursions: To view the detailed information of an excursion, click on the an icon on the home page and choose ‘View excursion’. You will get the View: Excursion screen as shown in the following image: Page 126 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en The screen includes the following information for an excursion: Details: Detailed information related to the excursion, such as related shipment or sector, related Event and Rules of the event. Information regarding start and end time of the excursion, its duration, whether it has been acknowledged or closed. Information about the way users interacted with the excursion like user who have acknowledged or closed the excursion. Graph: Redirects to the specific temperature graph of the sector or the shipment where the excursion was identified. Managing/Modifying an excursion You can select from a predefined list of reasons and provide an appropriate action for handling the excursion. Exporting Excursions: You can export and download the filtered excursions list as PDF or CSV file. Page 127 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 128 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.2.1. Excursion Icons Excursion Alert State Icons Icon Meaning Description Active Excursion The sensor value is currently in alert state. Stopped Excursion The sensor value has returned to the allowed range. Excursion User State Icons Icon Meaning Description Open Excursion The excursion has not been acknowledged yet by user. Acknowledged Excursion The excursion has been acknowledged by user. Closed Excursion The excursion has been closed by user. Page 129 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.2.2. Notifications about excursions Once smartview® has identified an excursion (shipment excursion, sector excursion or Q-Tag excursion) it will send out notifications to the predefined recipients via E-Mail and/or SMS. The excursion notification per E-Mail provides information about: • Excursion ID • Event Rule that has been reached • Start time of the excursion • Personalised message • Recipients • Last reported message • Value that has been reached # Type Who When How 1 Warning Main Recipients When sensor value reaches warning limit, but not excursion limit E-mail, or E-mail and SMS 2 Excursion Alert Main Recipients When sensor value reaches excursion limit, based on value and delay period (e.g. temperature > 8˚C for 15 minutes) E-mail, or E-mail and SMS 3. Excursion Reminder Main Recipients (and when escalated also Escalation Recipients When excursion value persists and excursion is not acknowledged by user within the repetition interval period E-mail only 4. Escalation Alert Escalation Recipients + Main Recipients When the excursion value persist and excursion is not acknowledged within the defined delay period E-mail, or E-mail and SMS (depending on Notification for Main Recipients and Escalation Recipients) 5. Escalation Escalation Recipients + Main Recipients When excursion value persists and escalation is not acknowledged by user within the repetition interval period E-mail only (depending on Notification for Main Recipients and Escalation Recipients) reminder Page 130 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Example Scenario Event Rules: Main Recipients: Notification Type (Main Recipients): Repetition Interval: Excursion can escalate: Notification Type (Escalation Recipients): Escalation Recipients: Event Rule: Temperature < 15.00 °C (59.00 °F) for 00:15:00, warn when < 18.00 °C (64.40 °F) Gerry, Andy E-mail and SMS 15 minutes Yes, with 30 minute delay period E-mail and SMS Jon, Marlen Let’s assume the following scenario for a cold room with this Event Profile: • At 10:31h a temperature value of 16.26˚C is received • At 11:16h a temperature value of 11.30˚C is received • The temperature remains above 8 ˚C for 4 hours, in which period the users do not acknowledge the excursion in SmartView. What messages will SmartView send? At 10:31h a WARNING MESSAGE is sent to Gerry and Andy by E-mail and SMS Page 131 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en At 11:16h an EXCURSION ALERT is sent to Gerry and Andy by E-mail and SMS Page 132 of 218 Berlinger &amp; Co. AG * The excursion E-Mail also provides a button the excursion in smartview®. SmartView Clinical Trial 5.4 - 1_en that redirects you to At 11:31h an EXCURSION REMINDER is sent to Gerry and Andy by E-mail. Page 133 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en At 11:46h an ESCALATION ALERT is sent to Jon and Marlen, as well as to Gerry and Andy by E-mail and SMS Page 134 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en At 12:01 an again an EXCURSION REMINDER is sent to Gerry, Andy, Jon and Marlen by E-mail. Page 135 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 136 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.2.2.1. Notification Q-Tag Excursion Although you do not get the notification about the Q-tag alarm in real time, SmartView has the capability to send notifications about the Q-tag excursions reported against Q-tag Alarms. As soon as a Q-tag data file is uploaded to the system, the system will send a notification about the Q-tag alarms reported in it. If a Q-tag is associated with a Shipment and an Event Profile with recipients defined is added to the shipment prior to the Q-tag file upload, then as soon as Q-tag file is uploaded, the notification email about the Q-tag will be sent to the recipients defined in the shipment profile. Below is an example of the Q-tag excursion notification email: However, the notification email about the Q-tag excursion will be sent to the main contact (e.g. Site Page 137 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Manager) instead of the recipients in the event profile, in the following cases: • Prior to the data file upload, if the Q-tag is not associated with a shipment prior to its data file upload • Prior to the data file upload, if no Event Profile is added to the shipment to which Q-tag is already associated with. Page 138 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.2.3. Acknowledge an Excursion In order to stop receiving notifications about an open excursion, it is important to acknowledge this. You have various options to acknowledge an excursion: From the homepage You can easily acknowledge an excursion from the homepage, by clicking on the ‘Acknowledge Excursion’, like shown in the video below: and then choose https://fast.wistia.net/embed/iframe/kioda5c25m From the Excursion overview From the Excursion list, you can choose to acknowledge your excursion by clicking on the choose ‘Acknowledge Excursion’ as instructed in the previous video. and From the ‘View Excursion’ page You also have the option to acknowledge the excursion by choosing to view the details of the excursion and click on as shown in the following video: https://www.youtube.com/embed/WFAmiwUKT3o?rel=0 From the Graph Another possibility to acknowledge excursions, is to go to the Graph in the Excursion details page and acknowledge the desired excursion directly from the Graph, as shown below: Page 139 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en After the excursion has been acknowledged After the excursion has been acknowledged by one of the recipients, smartview will send out an acknowledgement E-Mail informing all recipients about this action. The E-mail will contain information about who has acknowledged the excursion, which other recipients are aware of this, what the excursion details are, the root cause and the action taken. E.g. Acknowledgement E-Mail Page 140 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Once the excursion has been acknowledged, smartview will stop sending out notifications about the particular excursion, as this has already been processed by a user and has been taken into account. Page 141 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.2.4. Document an Excursion SmartView allows you to document additional information about an excursion. You can note down the Root Cause of an excursion and the corrective Action taken for the excursion. https://player.vimeo.com/video/175688790 You have various options to document the Root cause and Action for an excursion: From the homepage You can easily modify an excursion from the homepage, by clicking on the and then choose ‘Modify Excursion’. You can then add the Root cause and Action taken in the designated fields and click on to save your changes. From the Excursion overview From the Excursion list, you can choose to modify your excursion by clicking on the ‘Modify Excursion’ as instructed in the previous video. and choose From the ‘View Excursion’ page Page 142 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en When clicking on the Excursion ID (either from the E-Mail notification or from the Excursion Overview) you will be redirected to the Excursion Details screen. Click on to modify your Excursion. Page 143 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.2.5. Close an Excursion When an excursion situation no longer persists and corrective action has been taken, you can close the excursion. Closing an excursion is only possible after it has been acknowledged by the user. The sole purpose of closing an excursion, is to document proper handling of an excursion situation. You should not close an excursion when it still persists. The same as acknowledging an excursion, you have various options to close an excursion: • From the homepage • From the Excursion overview • From the ‘View Excursion’ page • From the Graph Page 144 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.2.6. Q-tag Excursions As soon as a Q-tag file is uploaded, the system checks for Alarms reported by the Q-tag and translates them into Excursions. Each Alarm reported in the Q-tag data file will be translated into a single Excursion. Configuration for an Alarm will be represented by the Rule of the corresponding Excursion. For example, if a Q-tag alarm configuration is set for temperature “above 44.9°C for 1h” then the excursion triggered against such an alarm would have its rule as “Temperature > 44.9 for 01:00:00”. If the alarm configuration has any established rule, then this is also indicated in its corresponding Excursion rule. Note: The Time of an Alarm and the Start time of an Excursion do not represent the same thing. The date and time of an alarm represent the time when the alarm was trigged based on a configuration. E.g. Time 10:00 of an alarm against configuration “above 44.9°C for 1h” indicates that at that time the temperature was found to be above 44.9°C for one hour. The actual breaching of the temperature was started an hour ago which is at 09:00 in this case. The Start time of the reported Excursion shows the actual start time when the breaching of the temperature is first identified. This helps to identify the exact point of time when the temperature started breaching the limit. The excursion also states the End time of an Excursion which usually represents the exact point of time when the temperature went back to the limit. In case the temperature did not come back to the limit before the Q-tag is stopped, then the Stop Time of the Q-tag is noted as End time for the excursion. The excursion reported against the Accumulated Alarm configuration does not have an end time. Notification about a Q-tag Excursion Although you do not get the notification about the Q-tag alarm in real time, SmartView has the capability to send notifications about the Q-tag excursions reported against Q-tag Alarms. As soon as a Q-tag data file is uploaded to the system, the system will send a notification about the Q-tag alarms reported in it. If a Q-tag is associated with a Shipment and an Event Profile with recipients defined is added to the shipment prior to the Q-tag file upload, then as soon as Q-tag file is uploaded, the notification email about the Q-tag will be sent to the recipients defined in the shipment profile. Page 145 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.2.7. Excursion markers in the graph The displaying of additional markers in the Sector/Shipment Graph is similar to the Shipment Milestone markers, but related to the Shipment Excursions. Effectively, it will show a dashed vertical line in either the color red, yellow, gray (depending on the excursion state) and indicate a box with the ID of the Excursion and click-through to the detail page of that Excursion. https://player.vimeo.com/video/178011135 The markers are colored according to the status of the excursion: Red – indicating open excursions. Yellow – indicating acknowledged excursions. Gray – indicating closed excursions. Page 146 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en When hovering the mouse over the Marker, this will display the detailed information of the Excursion. When clicking on the Excursion ID in the detailed information box, you get redirected to the detail page of the Excursion. You also have the possibility to acknowledge the excursion directly from the graph. Page 147 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.3. Audit Trail https://player.vimeo.com/video/178441495 The Audit Trail functionality of SmartView allows a user to track different users’ activities in SmartView. Such an activity includes the creation of a Shipment and/or Sector, adding or deleting a SmartSensor association to a Shipment and/or Sector and so on. The user has the option to view an overview of all the Audit Trail generated by the system. The user can filter the overview to track the activities of a specific user or to track the activities related to a Shipment or Sector. Note: Only a user with specific access rights can view the Audit Trail. To have the access to this feature, contact Berlinger Support. To view the overview of all the Audit Trail generated by the system, go to the menu item ‘Audit Trail’. You will see the overview of the system generated by the Audit Trail as show in the following image: Page 148 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Each entry in the audit trail is generated for the activity related to one of the objects: Shipment, Sector, Event, Event Profile, Event Rule, Sensor Association, Location, Shipment Milestone. Thus it may look difficult to identify all the activities related to a single object. For example how to track activities related to a Shipment. This purpose can easily be served by performing the following steps: View audit trail related to a single object You can view the audit trail related to a single object in one of the following ways: Use the filtering option: Filter the Audit Trail overview list by selecting the required Object (e.g. Shipment) and Object ID (e.g. Shipment ID). You will get a list of the Audit Trail containing the activities related to the specific object. Click on the Object ID: Alternatively you can get the list of Audit Trail related to a specific object by clicking on the Object ID in any of the visible entries. For example, the screen shot showing the Audit Trail overview includes audit trail for Create, Update for Shipment with ID 5. To view only the audit trail related to this shipment, simply click on the ID (i.e. 5) of any of the corresponding entries. As shown in the following image, you will get the audit trail list with activities related to that particular shipment. Page 149 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.4. Graph View The Graph View and handling of the Graph is identical in Sectors and Shipments. The only difference is, that within the Sector Graph I can choose and change the Time Period under the point Settings. Overview Settings (only available in Sector Graphs) Period: Choose the time period which should be displayed Sensor Type: Choose the tyepe of sensor which should be shown on the graph if available Page 150 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Graph Displays the graph with the following settings: Show the Behavior of the last hour on the graph y-scale range settings Choose a temperature range for the y-scale graph view which you have set under Site Settings —> Range Settings Page 151 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Export CSV File Print Chart or Download different images types for presentations Choose (mark) x-scale of graph view By cklicking in to the graph, holding down the left mouse button, dragging along the x-scale and releasing the mouse button you can zoom in into the part you have choosen. Page 152 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Press the Reset zoom button to get back to the initial position Create Note on the Graph You can click on the Graph and a new pop up window will open. Page 153 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en . The note will by shown on the Graph by a blue rhomb. You can cklick on it and the notes window will be opend. In the PDF report you have an option whether to export Graph Notes or not. Page 154 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 155 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.5. Custom Graph You can either choose a custom graph from the list or create a new custom graph Choosing a custom graph from the list: Creating a new custom graph: Click on the top right on graph. to start the process of creating a new custom A new window will pop up that will allow to enter a name for the new graph as well as the option to select another custom graph as template if one is available. In the following window 3 options will be available for graph type. Name Description Custom Period This allows to create a custom graph for a specific time period for non Q-tag Devices Latest Period This allows to create a custom graph for the latest period for non Q-tag Devices Q-tag Overlay This allows to create a custom graph for Q-tag Devices Page 156 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en If custom period is selected as option, the duration can either be limited with the duration modifier or the specific end date.If both are entered the end date will be used. By clicking on custom graph. the following view will be available where the devices can be added to the Page 157 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Modify a Custom Graph To modify a custom graph can be pressed within the custom graph overview and Modify Custom Graph selected. Delete a Custom Graph When within the detail page of the custom graph by pressing be deleted. on the top right the graph can Page 158 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.5.1. Detail On the detail page an overview of the selected devices in your custom graph is shown. It also shows which color of the graph is assigned to the certain devices. Page 159 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.5.2. Graph SmartView provides the capability to create a Custom Graph by overlapping the data from multiple sensors in order to perform an analysis of several used monitoring devices. The Custom Graph has the capability to include and combine data from sensors of the same type or of different types (e.g. Q-Tag, etc.) into one single graph. Each Custom Graph contains the following two elements: 1. Overlay of the temperature graph of the various sensors that shows the different values of the sensors in a single graph. 2. Statistical Table that shows the statistical information in table format, with easy indication of the lowest and highest maximum etc. Usability If the graph includes sensor data from real-time monitoring devices, the Custom Graph functionality offers the possibility to define the desired period for which the data should be included in the graph. If the graph will include sensor data from a Q-Tag USB logger device, the graph will overlay automatically the data based on the start time and the end time of the device. The Custom Graph is to be created manually by selecting the sensors that should be included in the graph in order to analyze their containing data. A maximum number of 100 sensors can be included and overlayed in the custom graph. The Custom Graph is commonly used for conducting Thermal Mapping studies inside a temperaturecontrolled facility, for sensor recalibration or for performing different tests with a larger number of sensors. Page 160 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Custom Graph Overwiew Custom Graph Zoom Area Click, hold and drag the mouse from one point to the other a zoom area will be selected as shown in the next graphic. Custom Graph Zoomed The next screenshot shows the zoomed in area. Go back to the overview by clicking the “Reset zoom” Button on the right. Page 161 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 162 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.5.3. Statistics Temperature Statistics Graph in Boxplot and Table format: Page 163 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 8.6. Shipment Analysis Report The Shipment Analysis Report is a document that provides a statistical analysis of shipments that have been monitored with SmartView and enables users to overlay multiple shipments in a single graph. Each Shipment Analysis Report contains the following three elements: 1. Overlay of the temperature graph of the various shipments. As these shipments may be performed at different times, the temperature graph is based on a relative time. 2. Statistical Overview Graph (see below) that provides a graphical overview of the maximum, minimum, average and standard deviation for each shipment that is included. 3. Statistical Table that shows the statistical information in table format, with easy indication of the lowest and highest maximum etc. The Shipment Analysis Report is generated manually by selecting the specific shipments that need to be included in the analysis. This functionality can be accessed directly from the menu option or from the shipment overview screen. E.g. Shipment Analysis Graph E.g. Shipment Analysis Report Page 164 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 165 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 9. Configuration • Carriers • Customers • Event Profiles • Packing Systems • Products • Clinical Trial • smartAlert Unit Page 166 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 9.1. Carriers https://player.vimeo.com/video/178601186 Carriers The Carriers menu item allows you to define a subset list of Air Carriers from a list of all the carriers available in the system that you will use in smartview when working with carriers. The carrier list available in the system includes around 250 commercial Air Carriers. Before you use the carrier in other places (for example for a Shipment) you need to define the Air Carriers subset list by adding the frequently used carrier from the main list. Overview of existing Carrier To view an overview of the air carrier subset list, click on the menu item Configuration: Carriers. As shown in the following image and you will get the screen with the air carrier subset list. Page 167 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en To add a new carrier to the list simply click on the carrier from the dropdown list. button and choose the desired To remove an air carrier from the subset list, simply click on the select delete. button next to the carrier and Note: You cannot remove a carrier from the subset list if it has already been referred somewhere. Page 168 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 9.2. Customers Create Customers The Customers menu item provides an overview of all the customers created in the system. This screen also enables you to define new customers for your shipments and to edit existing customers. You can also filter the list of customers depending on your preferences. To add a new customer, simply click on the button and fill in the name of your customer. After creating a customer, you will be able to assign this to one or more shipments. Modify Customers You can edit your customers by clicking on the button. Enable/Disable Customers If you want to enable or disable a Customer, use the toggle Enable/Disable on the bottom of the details tab in modify mode. Choose to modify in the Customer tab. Page 169 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Scroll down to the toggle Enable/Disable and change settings. Page 170 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Click save to save your settings. ! A Customer cannot be deleted, only disabled. Page 171 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 9.3. Event Profiles One of the core capabilities of SmartView is the event management, which includes defining events, identifying, handling and reporting on event excursions. An event is the occurrence of a pre-defined situation. Note that this functionality is relevant when real-time shipments loggers are being used. Note further, some loggers have their own, built-in, event profiles. SmartView enables users to define business rules for such situations. An Event Excursion represents an alert situation which indicates the breach of one of the business rules that are defining the event. With continuous sensor measurements, SmartView can identify the breach of a rule and thereby can report on an excursion. The user needs to define appropriate Event Profiles in the system first. For monitoring a shipment or a facility, he needs to select one of the predefined Event Profiles that is applicable for it. Selecting an Event Profile for a shipment or sector means that the business rules, as defined in the Event Profile, are now applicable to the specific shipment or sector. In case of a TCI, stability budgets are not controlled by event profiles, but are configured on a product level. To access the Event Profiles, you need to go to the ‘Configuration’ tab in the Menu bar and click on Event Profiles. Page 172 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 173 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 9.4. Packing Systems Create Packing Systems The Configuration: Packing Systems menu item allows you to define the Packing Systems (e.g. Envirotainer). In practice the Packing System refers to a kind of packaging to which a Smart Sensor is mounted to monitor the relevant shipment. You can define a list of frequently used Packing Systems for your shipments that are monitored by SmartView. While creating a Smart Sensor association to a Shipment, you can optionally select the Packing System. Overview of Existing Packing Systems To view an overview of Packing Systems already defined in the system, click on the menu item Configuration: Packing Systems. You will get an overview of all the Packing Systems as shown in the following image. The coloured icons indicate whether the packing system is: enabled or disabled Adding a Packing System To create a new Packing System click on the button. Provide a nonexisting and non-empty name for the new Packing System and click on the OK button. The Packing System name can have a maximum length of 64 characters. Editing and Deleting a Packing System To Edit an existing Packing System simply click on the for the Packing System. Note: You cannot delete an existing Packing System if it has already been defined against a Shipment Association. Page 174 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Modify Packing Systems Changed Packing System from Package A to SkyCall CRT750 Modify Storage Conditions You can choose a Storage Condition for your packing system which you have predefined under Site Settings / Storage Conditions. Page 175 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Delete Packing Systems * The Packing System can only be deleted if the Packing System is not in use anywhere. Page 176 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 9.5. Products Products Overview Create your Clinical Trial Products you ship with the button Click the small black triangle to see the settings of your Product Modify If you want to Modify your Product settings, click the Product name to get inside the product settings. Click to change settings and save afterward. Modify Storage Conditions Page 177 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en You can choose a Storage Condition for your product which you have predefined under Site Settings / Storage Conditions. Details Stability Data Mean Kinetic Temperature (MKT) Fill out the data for the the MKT settings. It is also possible to disable the MKT. Page 178 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Alarm Thresholds Define the alarm thresholds for your product. You can add up to 8 threasholds. * If the alarm thresholds is disabled or enabled, then the setting applies to all thresholds created. Batches A product itself can have multiple batches. The batches are visible within the general view of a Prduct. Page 179 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en TCIs will be automatically be linked to a batch if the name matches with a batch for that product. Adding a Batch to a product Press Modify on the top right corner in the Product view. In the modify view then select the tab “Batches” On the right side new batches can be now created by entering the Production date, the name and the Status. Page 180 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Onces it is created the stability budget rules can also be defined for the batch by pressing the 3 bars and selecting Stability Budget. * The stability check will be performed by using the Batch stability rules if available Audit Trail The Products Audit Trail shows you all the changes you have made. Page 181 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 9.6. Clinical Trial Details Clinical Trial To create a Clinical Trial, click on the Create Clinical Trial tab in the main menu. Choose a name for your Clinical Trial and click OK. General Add the following information to set up the Clinical Trial. Page 182 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Topic Description Name Name of the Clinical Trial (internal Product name for example) Start Date Start of the Clinical Trial Program Additional deeper information about the Clinical Trial Phase Enter the phase of the Clinical Trial Description Description for more information about the Clinical Trial Contact Details Add the following contact details for the parties involved in the Clinical Trial. Topic Description Sponsor Details Enter the name of the sponsor (for internal use only) CRO Details Enter the name of the CRO (for internal use only) Other Contact Details Enter other contact involved (for internal use only) Page 183 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Products Now add your products to the Clinical Trial. * Note: You must first create the products before you can assign them to the Clinical Trial. More information how to manage products With the Save button you can save the entered information and with the Modify button you change the information. Page 184 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Audit Trail Page 185 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 9.6.1. TCI TCI Details Page Under this page you find all important details from the TCI. The status of the stability budget can be seen on the right side of the details page if any information in that regard is available. Page 186 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en With a click on PDF a TCI PDF Report can be downloaded with the following options: TCI Graph Page in this page a graph will display the measured values. Once the stability budget is reached the band of the desired values will switch to a lighter green. Also the reaching of the stability budget will be marked by an “!” exclamation mark. Page 187 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en If available by the devices the measured type of data can be switched as well. Stability Budget Status This page give an overview over the stability budget used and still available. Page 188 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Activities This page give an overview over the recorded activities. A broad summary can be seen don the top of the page and and a more detailed list is displayed in the second half. History This page displays previous events sorted by date. Related Excursion In this page excursion are listed that stand in direct relation with the TCI. Page 189 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 9.7. smartAlert Unit The smartAlert Unit menu item allows you to add an audio/visual alert device for your facility. https://player.vimeo.com/video/178155401 Note: This functionality will only be visible if you are using the application for facility monitoring and if an audio/visual alert device has been installed in your facility. To add an alert device, click on the image: button as indicated in the following Page 190 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en This will lead you to the screen that allows you to add a location, a serial number and a telephone number for your alert device. After defining the details for your alert device, you have the option to test the device. Click on the Test Alert Device button and SmartView will automatically send a trigger to the defined phone number for test purposes. If the test is successful and you want to save the changes to your alert device, click the Create Alert Device button: Page 191 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10. Administration The Administration button in the Main Menu enables you to Manage your own and other users’ account settings. This functionality provides two options: • User Management – The User Management option allows you to create new users and to modify the settings of existing users (status, access rights, restrictions, etc.) • Password Policy – The Password Policy functionality enables you to define a personalised password policy for your users. * The Administration functionality is only available to Admins. Page 192 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10.1. User Management In SmartView we distinguish between three types of SmartView users: Admin – have full access and full rights in SmartView including viewing, editing and deleting information. SuperUsers also have the role of administrators of the database and can manage other user accounts including defining the access rights and setting user restrictions. User – regular users with viewing and/or editing rights, depending on the access rights set by the SuperUser. Q-Tag upload user – users who only have the right to upload Q-Tag data in SmartView. These type of users will only be able to view the screen that allows them to upload the Q-Tag data file. No other access rights are applicable to these type of users and no other information is available for them. Page 193 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10.1.1. User Templates The Admins have the option to manage other users including to create, enable or disable users. https://player.vimeo.com/video/178190982 To create a User, simply click on the button and fill in the necessary contact details. An Admin can View the details of any type of user by clicking either on the user name and can modify the details of that specific user by clicking on the button. Page 194 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en A user (of any type) cannot be deleted, but can be suspended. An Admin can suspend a User, a Q-Tag upload user or another Admin in case one is not entitled to have access to the system any longer. This can be done by selecting the ‘Suspended’ status in the Modify screen and by clicking the Save button. The same way, a user can be activated, after it has been suspended, by selecting the ‘Activated’ status. User Restrictions An administrator can restrict a user to one or multiple locations. Navigate to User and click modify. Page 195 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Now you can select the locations you want to restrict. Page 196 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 197 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10.1.2. Admin For Admins, a tab called “User Management” will appear in the menu bar as displayed in the below image. By clicking on the ‘User Management’ tab, the Admin can edit the configuration of any type of user by selecting it from the overview list. A number of rights are assigned to the Admin: Page 198 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en https://player.vimeo.com/video/178461865 An Admin can View the details of any type of user by clicking either on the user name or on the icon in the overview list. • An Admin can add a User, Q-Tag upload user or another Admin by clicking on the ‘Create user’ button in the User Overview page. • An Admin can edit the account settings for a User or for another Admin by clicking on the icon of an individual user in the overview list or by clicking on the user name and then on the button of that particular user. • A user (of any type) cannot be deleted, but can be suspended. An Admin can suspend a User, a Q-Tag upload user or another Admin in case one is not entitled to have access to the system any longer. This can be done by selecting the ‘Suspended’ box in the Edit: User screen and by clicking the Save button. • An Admin can activate any type of user in case the account needs reactivation following the same steps as for suspending the user by selecting the ‘Active’ box in the Edit: User screen and by clicking ‘Save’ . • An Admin can trigger a password reset for any of the users by clicking on the Page 199 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en button. An automatic email providing a link will be sent to the email address for which the password should be reset. • An Admin can select and modify the access rights for a regular User, by clicking on the button. Note: The access rights of an Admin cannot be modified, as these are set by default to have full rights and full access in SmartView. • For the Q-Tag upload users, the option to edit the access rights will not be visible, as the access rights for this type of users are set by default to only be able to upload Q-Tag data files. The QTag upload users will only see a screen as displayed in the following image: • An Admin can export an Excel document containing all the existing users in the system by clicking on the ‘Export’ button. Create a new User Template An Admin can create the following User Templates: Create a new Template with the following steps Name and description of template Page 200 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Permissons of the new template Now you can give permission for your new template and save it. When creating a new user you can use the templete from the list. Page 201 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Create a User Template from an existing User Only Administrators can make new User Templates. You can not make a Template out of a Administrator Account. You cannot assign Templates to CLm doc User uploaders only Page 202 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10.1.3. Restricted user accounts SmartView provides the option to restrict the viewing and/or editing rights of regular users. This can be done from the “Modify user” option or from the button of a specific user. https://player.vimeo.com/video/178447190 Access can be restricted for ONLY ONE of the three filters: Carriers – users can view and/or edit only the information related to a specific carrier and no other information. Customer – users can view and/or edit only the information related to a specific customer and no other information. Location – users can view and/or edit only the information related to a specific location and no other information. Note: Only Admins have access to this feature and have the right to restrict the viewing and/or editing rights of a user. Please note that only one restriction per user can be applied, e.g. a user can be restricted to a location, but the same user cannot be restricted to another entity. Page 203 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10.2. Password Policy smartview by default has a highly secure password policy. However, you also have the option to strengthen this policy if necessary. Create https://player.vimeo.com/video/178449758 You can create a new password policy and determine your own requirements for the password of your users by clicking on the button. Choose the new requirements for your password policy. Page 204 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en The created password policies can be activated or deactivated at any time, and you can recognise the status of a password policy by the status icon. To activate/deactivate a password policy, simply click on the button and choose your action. A pop-up will appear, asking you whether you would like to force a password reset for all users or whether you would like to schedule this action: Page 205 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Page 206 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10.3. Site Settings General: The Administrator can activate the “Reason for Change” functionality which will require the user to provide a reason when changing shipment or facility monitoring information. Approve Automatically The Administrator can define to automatically Approve all shipments that contain no excursions The following points can be modified in the Site Settings • • • • • • Range Settings Storage Conditions Root Causes Login Security Email Recipient API Page 207 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10.3.1. Range Settings Range Settings Temperature y-scale for Graph View A Super user can define upper and lower limits for the graph view (y-scale) to make easier to compare different reports side by side. Fields that should be provided: – name for the template - lower limit (optional) - upper limit (optional) At least one of the limits should be filled in. Ranges set on the basis of the user settings (F or °C). Max amount of the ranges are 10. Page 208 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10.3.2. Storage Conditions Storage condition settings are used in multiple areas of SmartView. Therefore, SmartView provides the functionality to define storage conditions in the Admin settings so that these conditions can be reused when assigning to products, packaging systems, shipments and sectors. Page 209 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10.3.3. Root Causes In the Root Causes tab, the administrator can define customized reasons for excursions. These reasons can then be used when managing a specific excursion by selecting a root cause and providing an appropriate action for handling the excursion. Page 210 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10.3.4. Login Security System will lock out user account after repeated, unsuccessful login attempts. Administrator can provide amount of unsuccessful login attempts and block time period on which user will be blocked. Regular user do not have access to the tab Login Security. System will show warning message on the login page that user account was blocked. System will send email notifications to a user that his account was blocked because of too much unsuccessful login attempts. Also email will be send to the site admin. Page 211 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10.3.5. Email Recipients Upload Notification Recipients: Up to 5 additional E-mail recipients can be added by the Admin. Calibration Certificate Expiration Notification Recipients: Up to 5 additional E-mail recipients can be added by the Admin. 2 months before a calibratoin of a device expires an email reminder will be sent per mail to the Admin and up to 5 additional users (optional) assigned by the Admin. PSDC recipients option: Recipients can be defined regarding the PSDC status of each TCI. Page 212 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en Shipment Approval Digest Notification Recipients Up to 5 additional E-mail recipients can be added by the Admin. Page 213 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 10.3.6. API In the API Tab the Admin can allow integration with other applications by way of • Webhook URL’s • API Users A password will be automatically generated. Page 214 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en API Structure * The structure of the SmartView API and the available Endpoints you will find here. Page 215 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 11. Profile The Profile shows you information about the user and settings. Page 216 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 11.1. User Profile Settings Subscriptions Password Page 217 of 218 Berlinger &amp; Co. AG SmartView Clinical Trial 5.4 - 1_en 12. Sign Out By using the “Sign Out” button, you can log out of SmartView. Page 218 of 218 ">

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