epBlue GxP - Eppendorf

epBlue GxP - Eppendorf
™
ual
EN)
manual
Register your instrument!
www.eppendorf.com/myeppendorf
epBlue GxP™
Software manual
from software version 40.2
Copyright© 2015 Eppendorf AG, Germany. All rights reserved, including graphics and images. No part of
this publication may be reproduced without the prior permission of the copyright owner.
Focus Diagnostic® is a registered trademark of Focus Diagnostic, Inc., USA.
Qiagen® and Rotor-Disc® are registered trademarks of Qiagen GmbH, Germany.
epMotion®, Eppendorf Tubes ®, epT.I.P.S.®, and Eppendorf ThermoMixer® are registered trademarks of
Eppendorf AG, Germany.
Eppendorf® and the Eppendorf logo are registered trademarks of Eppendorf AG, Germany.
Registered trademarks and protected trademarks are not marked in all cases with ® or ™ in this manual.
epMotion VAC sealing foil U.S. Pat. No. 6,666,978
epMotion optical sensor U.S. Pat. No. 6,819,437
epMotion gripping tool U.S. Pat. No. 7,462,327
U.S. Design Patents are listed on www.eppendorf.com/ip
The software of the device (firmware) contains open source software. License information is available on
request from Eppendorf AG, Germany.
Only for epMotion M5073, M5073c, 5075m and 5075mc: Limited Use Label License NOTICE TO
PURCHASER; LIMITED LICENSE FOR RESEARCH USE ONLY.
This product and its use may be covered by one or more patents owned by Gen-Probe Incorporated. The
purchase price for this product includes only limited, nontransferable rights under certain claims of certain
patents owned by Gen-Probe Incorporated to use this product for research purposes only. No other rights
are conveyed. Purchaser is not granted any rights under patents of Gen-Probe Incorporated to use this
product for any commercial use. Further information regarding purchasing a license under patents of
Gen-Probe Incorporated to use this product for any other purposes, including, without limitation, for
commercial use, may be obtained by contacting Gen-Probe Incorporated, Attn: Business Development
Department, 10210 Genetic Center Drive, San Diego, California 92121-4362, U.S.A.
5075 901.269-01/122015
Table of contents
epBlue GxP™
English (EN)
Table of contents
1
Operating instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.1
Using this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2
Danger symbols and danger levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2.1
Danger symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2.2
Danger levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3
Symbols used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4
Abbreviations used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5
Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.6
Revision history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2
Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3
Product description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.1
Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.1.1
epBlue GxP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.1.2
epMotion 5075 with epBlue GxP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.1.3
Modification kit for epBlue GxP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.1.4
epBlueID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.1.5
epBlue Assistants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.2
Delivery package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4
Working in accordance with legal regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5
Basic concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.1
User groups and their rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.1.1
Protection against unauthorized access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.1.2
Rules for passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.2
Electronic documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.2.1
Digital signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.2.2
Status of electronic documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.2.3
Revisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.2.4
Handling of signed applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.2.5
Digital key pair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.2.6
Certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.3
Audit trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.3.1
Providing a reason for actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
6.1
Requesting a GxP activation license . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
6.2
Importing the activation license . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6.3
Setting up the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6.3.1
Logging in as an administrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6.3.2
Configuring epBlue GxP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
7
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
7.1
Login and changing the password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
7.1.1
Logging into epBlue GxP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
7.1.2
Unlocking epBlue GxP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
7.1.3
Changing your own password. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
3
4
Table of contents
epBlue GxP™
English (EN)
7.2
7.3
7.4
7.5
7.6
Using digital signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
7.2.1
Signing applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
7.2.2
Signing logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
7.2.3
Managing revisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
7.2.4
Signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
7.2.5
Signatures in applications and logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Labware in signed applications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
7.3.1
Changing signed applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Working with signed PDF documents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
7.4.1
Exporting data as signed PDF documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
7.4.2
Exporting digital certificates from epBlue GxP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
7.4.3
Importing the master certificate into the PDF reader. . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.4.4
Verifying signatures and certificates in PDF documents. . . . . . . . . . . . . . . . . . . . . . . . 43
Audit trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.5.1
Opening the audit trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.5.2
Displaying the details of an entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.5.3
Sorting entries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.5.4
Creating a filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
7.5.5
Editing a filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
7.5.6
Selecting a filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
7.5.7
Deleting a filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
7.5.8
Selecting columns to be displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
7.5.9
Printing and exporting the audit trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
7.5.10 Audit trail categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Creating and validating checksums . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
7.6.1
Importing and validating files with checksums . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
7.6.2
Exporting files with checksums . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
7.6.3
Validating checksums in external software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
7.6.4
Creating checksums in external software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
8
Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
8.1
Expanded user administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
8.1.1
Setting the security of user accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
8.1.2
Configuring the authorization scheme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
8.1.3
Defining signature rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
8.1.4
Unlocking a user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
8.1.5
Deleting a user account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
8.2
Enabling checksum validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
8.3
Archiving data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
8.3.1
Archiving applications and logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
8.3.2
Archiving the audit trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
8.4
Checking the system configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
9
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
9.1
General errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
10 Ordering information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
10.1 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Operating instructions
epBlue GxP™
English (EN)
1
1.1
Operating instructions
Using this manual
Your epMotion operating manual consists of hardware instructions and software instructions. Separate
instructions exist for some optional software modules.
The operating manual is part of the product.
The current version of the operating manual can be found on our website: www.eppendorf.com.
 Read the operating manual in full before using the device.
 Store the operating manual at an easily accessible location.
 The device may only be transferred with the operating manual.
 If the operating manual is lost, replace it immediately. Please contact Eppendorf AG for further details.
1.2
Danger symbols and danger levels
1.2.1
Danger symbols
The safety instructions in this manual appear with the following danger symbols and danger levels:
Material damage
1.2.2
Danger levels
DANGER
Will lead to severe injuries or death.
WARNING
May lead to severe injuries or death.
CAUTION
May lead to light to moderate injuries.
NOTICE
May lead to material damage.
1.3
Symbols used
Depiction
Meaning
1.
2.
Actions in the specified order

Actions without a specified order
•
Text
List
Display text or software text
Additional information
5
6
Operating instructions
epBlue GxP™
English (EN)
1.4
Abbreviations used
BCR
Barcode reader
CSV
Comma Separated Value
CFR
Code of Federal Regulation
DNA
Deoxyribonucleic acid
DWP
Deepwell plate
epT.I.P.S.
Eppendorf Totally Integrated Pipetting System
HEPA
High Efficiency Particulate Air (filter)
GxP
Good Practice — Guidelines for a good operating practice
IQ
Installation Qualification
LH
Liquid Handling
LIMS
Laboratory Information Management System
MTP
Microplate
OQ
Operational Qualification
PCR
Polymerase chain reaction
PDF
Portable Document Format
TMX
Eppendorf ThermoMixer module
Operating instructions
epBlue GxP™
English (EN)
USB
Universal Serial Bus
UV
Ultraviolet radiation
VAC
Vacuum unit
1.5
Glossary
A
Administrator
User possessing the rights for the administration of epBlue.
Application
Program for a dedicated application. An application comprises the procedure and the equipping of the
worktable.
Audit trail
Chronological record of events that change the database or the state of the system.
B
Barcode reader
Device for scanning a barcode.
C
Certificate, digital
Dataset that enables the identity of a person, organization, or system to be assigned to a digital signature.
CleanCap
Optional epMotion equipment. The CleanCap includes a HEPA filter and at least one UV lamp.
Command
Step in a procedure. Various parameters are set for commands. Each command triggers an action, e.g., the
transport of liquids.
Control device
Device for controlling the epMotion. Depending on the equipment of the epMotion, a MultiCon PC or a
EasyCon Tablet is available.
CSV file
Text file for saving and exchanging structured information.
7
8
Operating instructions
epBlue GxP™
English (EN)
D
Destination labware
Rack or plate with destination positions.
Destination position
Position in the labware that exclusively is destination of liquid transfers.
Dispensing tool
Tool that aspirates and dispenses liquid. Single-channel dispensing tools and eight-channel dispensing
tools are available for various volume ranges.
E
Entry list
ID list assigned to a labware. The ID list contains the name of the labware, IDs for the positions of the
labware and descriptions. epBlue imports and exports the IDs of the labware with entry lists. epBlue can
process entry lists in the formats CSV and XML.
epBlue
Software for creating and administrating applications and labware. The epBlue software is used for
controlling the epMotion.
epBlue ID
With the epBlue ID module, you can track samples during the application. The labware is labeled with IDs
for this purpose. The sample tracking is documented automatically.
epT.I.P.S. Motion
Pipette tips of the epMotion. epT.I.P.S.® Motions are available with or without a filter. The abbreviation
stands for Eppendorf Totally Integrated Pipetting System.
F
Filling volume
Maximum volume of a labware. The filling volume is higher than the working volume. The epMotion
removes liquid from the labware up to the filling volume.
G
Gripper
Tool that transports labware.
H
Height adapter
Adapter for low labware. The height differences between the labware is offset to decrease the tool holder
paths, and therefore decrease the cycle time of the application.
Operating instructions
epBlue GxP™
English (EN)
HEPA filter
Air filter. The filter prevents particles such as dust and germs from the environment entering the epMotion
workspace.
I
ID
Character string which is used by the epBlue ID module to identify the labware.
Input list
ID list containing information on the source labware. The input list contains the IDs of the source positions.
epBlue creates an input list for each source labware with activated ID tracking.
Intermediate labware
Rack or plate with intermediate positions.
Intermediate position
Position in the labware that is source and destination of liquid transfers.
L
Lab administrator
User possessing the rights for the administration of applications and labware.
Labware
Racks, plates, tips, etc. which are placed on the worktable.
Location
Area where labware is placed on the worktable.
M
MagSep
System for nucleic acid preparation with the epMotion. The MagSep consists of a magnetic finger module,
an Eppendorf ThermoMixer module, a PrepRack, and reagents.
MultiCon PC
A computer with touchscreen. You can control your epMotion using the computer and the epBlue software.
P
Pattern
Pattern in which liquid is aspirated and dispensed. Patterns are defined in a transfer command. Patterns are
defined as regular patterns and irregular patterns. Patterns are independent in x-direction and y-direction.
Procedure
Sequence of commands executed consecutively. Part of an application.
9
10
Operating instructions
epBlue GxP™
English (EN)
R
Rack
Mount for tubes or pipette tips.
Remaining volume
Volume that cannot be removed from a vessel. Caused by the distance from the pipette tip to the vessel
base, defined in the software, and the defined immersion depth of the pipette tip in the liquid. The pipette
tip cannot aspirate the volume. The remaining volume depends on the vessel geometry.
Reservoir
Reservoirs are used for preparing reagents. Reservoirs are hung in a ReservoirRack or placed directly on
the worktable.
Result list
ID list with information on destination labware and intermediate labware. The result list contains the IDs of
destination positions and intermediate positions. epBlue creates a result list for each destination labware
and intermediate labware for which ID tracking is active.
S
SafeRack
Rack with ep.T.I.P.S. Motion pipette tips. The SafeRack features a partition that prevents the contamination
of adjacent tips. If you want to use the tips several times, use SafeRacks.
Signature, digital
Technical term for an electronic signature that is encrypted using cryptographic methods.
Signature, electronic
Legal term for an electronic equivalent of a legally binding handwritten signature. The legal meaning of
different forms of electronic signatures is defined in country-specific laws.
Source labware
Rack or plate with source positions.
Source position
Position in a labware that exclusively is a source of liquid transfers.
T
Thermal module
Heat plate for labware. The heat plate is integrated in the worktable.
Thermoadapter
Temperature-controlled adapter that is not transported with the gripper. Plates are inserted into the
thermoadapter.
Thermoblock
Temperature-controlled adapter that is transported with the gripper.
Operating instructions
epBlue GxP™
English (EN)
There are 2 types of thermoblocks:
• Thermoblocks: Thermoblocks, into which plates are inserted.
• Thermoblocks with plates Thermoblocks that are permanently connected with a plate.
Thermorack
Temperature-controlled rack for smaller vessels, e.g., Safe-Lock tubes for 0.5 mL, 1.5 mL or 2 mL.
Tube
A micro test tube or a single well in a plate.
V
Vacuum unit
The vacuum unit uses a vacuum to suck liquid from a filter plate. The vacuum unit consists of a vacuum
manifold, vacuum pump, and Vac Frame.
W
Work volume
Filling volume minus volume of the immerging pipette tip. The epMotion fills the vessels up to the working
volume.
Worktable
epMotion work surface that labware and tools are placed on. In the software, the epMotion worktable is
represented as epBlue worktable.
1.6
Revision history
Operating manual
Version
Date
Software version
5075 901.269
00
March 2014 epBlue 40.2
Manual created
01
December
2015
Update to a new software version
epBlue 40.4
Changes
11
12
Operating instructions
epBlue GxP™
English (EN)
Safety
epBlue GxP™
English (EN)
2
Safety
The intended use and safety instructions from the hardware and software operating manuals apply when
using the epMotion with the epBlue GxP software.
NOTICE! Data loss due to mains/power outage.
If there is a mains/power outage, the computer will switch off unexpectedly. Data can no
longer be written into the epBlue database. The epBlue database is then incomplete.
 Connect the computer to an uninterruptible mains/power supply.
NOTICE! Data loss due to manipulation.
Manipulations to the settings of the operating system and to the software and hardware
settings impair error-free operation.
The recording of electronic documents can be disturbed. Communication between epMotion
and epBlue can be disturbed.
 Do not change the system configuration in the operating system, e.g., drivers.
 The operating system may only be changed by authorized service personnel.
NOTICE! Deletion of data from the database during archiving.
When you archive data, epBlue exports the data as PDF documents. The data are removed
from the epBlue database.
Archived data cannot be reimported into the epBlue database.
 Do not archive any data that you still need.
13
14
Safety
epBlue GxP™
English (EN)
Product description
epBlue GxP™
English (EN)
3
3.1
Product description
Features
3.1.1
epBlue GxP
The epBlue GxP software is designed to assist users with the creation and management of electronic
documentation. The software has been developed in compliance with the US Code of Federal Regulation
(CFR) 21, part 11.
epBlue GxP has the following functions:
• Specify an authorization scheme for applications and logs.
• Manage applications and revisions.
• Export and archive user data as digitally signed PDF documents.
• Manage user accounts.
• Automatic and continuous recording of an audit trail.
• Verify checksums.
• Verify hardware and software components.
• Optional epBlue ID: Track labware that is marked with a barcode by ID lists.
You can examine the development and change documentation for the epMotion 5075 with epBlue GxP at
Eppendorf AG.
3.1.2
epMotion 5075 with epBlue GxP
You can order the epMotion 5075 with MultiCon PC together with the epBlue GxP software installed.
The system is delivered with the appropriate validation and documentation by Eppendorf. The system is
installed at the customer.
3.1.3
Modification kit for epBlue GxP
You can order the epBlue GxP software as a modification kit for a epMotion 5075 with MultiCon PC.
The modification kit does not include any documentation, such as logs. The user is responsible for system
validation.
The Eppendorf AG service team is available to service and certify your device.
Information on the services offered can be found on our website www.eppendorf.com.
15
16
Product description
epBlue GxP™
English (EN)
3.1.4
epBlueID
You can extend the epBlue GxP software with the epBlue ID module.
Information on the epBlue ID can be found in the software operating manual.
3.1.5
epBlue Assistants
You can create applications in epBlue GxP with the epBlue Assistants. The applications are not executed
within the epBlue Assistants in order to comply with GxP requirements.
 Use the Save as function to save applications created with epBlue Assistants.
 Start applications in the Application Editor of epBlue.
Applications created with epBlue Assistants have the status unsigned.
3.2
Delivery package
Number
Description
1
epBlue GxP software
1
epBlue GxP installation guide
1
epBlue GxP operating manual
1
Documentation folder
Folder for certificates and documentation
Information on the delivery package of the device and the epBlue GxP software can be found on the
delivery note.
Working in accordance with legal regulations
epBlue GxP™
English (EN)
4
Working in accordance with legal regulations
epBlue GxP provides you with functions that support you in the creation and provision of electronic
documents. In order to fulfill additional legal regulations for the approval of your electronic documents by
government agencies, you must create and observe special basic conditions as the operator of the epMotion
5075 with epBlue GxP system. As an example, the regulations for U.S. federal law 21 CFR Part 11 for
submission to the U.S. Food and Drug Administration are described in the following section. In other
countries or for other government agencies, the legal regulations may vary.
User training
obligation
§11.10 (i). Persons who maintain and use the epBlue GxP must demonstrate that
they have adequate experience and have received appropriate training and
instruction. Corresponding training courses are offered by Eppendorf.
Bindingness of the
digital signature
§11.10 (j). You are obligated to establish and observe legal rules, defined in
writing, for handling digital signatures in epBlue GxP and the legal bindingness of
these signatures. We recommend that the obligation to observe these rules be
confirmed by every user with a handwritten signature.
§11.50 (a). You are obligated to verify the identity of persons authorized to use
digital signatures. It is recommended to document the identity verification in
writing and to enter the real first and last name in epBlue GxP when creating a
user account. This information appears in the electronic documents.
§11.100 (c). Before the signatures are used or during their use, persons who use
electronic signatures should provide verification to the government agency (FDA)
that the electronic signatures in their system, which were used on or after August
20, 1997, apply as the legally binding equivalent of traditional handwritten
signatures.
Handling system
accesses
§11.200 (a)(3). You must ensure that an electronic signature cannot be executed
by any person other than the lawful owner of the system access. If passwords are
lost, a user belonging to the user group Administrator can assign a new password
to a user. If a password is changed by a user belonging to the user group
Administrator, Eppendorf recommends that it is recorded in writing and that the
user in question is present and must immediately define a password for the user
account which is only known to him or her.
Availability of
electronic
documents
§11.10 (c). You are obligated to guarantee proper access to documents during the
retention period. epBlue GxP provides backup and archiving functions for this
purpose.
The system must be operated on an uninterruptible power supply in order to
prevent data loss due to power failure.
§11.300 (c). You are obligated to establish and comply with procedures in case of
loss or theft of system access data. To be able to manage system accesses in
epBlue GxP you must have a user account belonging to the user group
Administrator. If no valid administrator access is available (e.g., due to loss of
password or automatic locking after the password was entered incorrectly several
times), the system cannot be administered without a reinstallation. You are
responsible for guaranteeing administrator access. Eppendorf recommends
setting up at least one additional administrator access in epBlue GxP.
17
18
Working in accordance with legal regulations
epBlue GxP™
English (EN)
Handling system
documentation
§11.10 (k). You are obligated to establish and observe a regulation for the
distribution, access and use of documentation for the operation and maintenance
of epBlue GxP and epMotion 5075.
System maintenance §11.10 (h) and §11.300 (e). You are obligated to guarantee the proper and safe
functioning of system components and to ensure that no unauthorized
modifications have been made to the system. Eppendorf has maintenance
contracts available for this purpose.
The paragraphs refer to 21 CFR Part 11. You can find the legal text online at http://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm.
Basic concepts
epBlue GxP™
English (EN)
5
Basic concepts
This chapter explains how to create and manage electronic documents in epBlue GxP.
5.1
User groups and their rights
It is required when working with electronic documents that all manipulations must be clearly assigned to a
person at all times. epBlue GxP ensures this. epBlue GxP saves the signature of the user changing an
electronic document in the audit trail and when a digital signature is created.
epBlue GxP has five user groups to facilitate user management. These user groups can be used to define
the rights of users based on their roles in your organization. Each user group has special rights to execute
digital signatures.
User group
Example of the rights of the respective user groups
Guest
Lab employee who executes authorized applications, but does not create any
applications.
User Level 1
Lab employee who creates ("create") electronic documents and executes
authorized applications.
User Level 2
Lab employee who is responsible for testing and validating ("review") electronic
documents.
Administrator Lab
Lab manager who is responsible for authorizing ("authorize") and exchanging
electronic documents, as well as managing user accounts and data.
Administrator
System administrator who maintains the device and software, creates a back-up of
the epBlue database and manages the system.
The administrator does not create any applications nor executes any applications.
A detailed description of the user rights and the user groups can be found in the epBlue GxP software.
The rights of the user groups Guest, User Level 1, User Level 2 and Administrator Lab are structured
hierarchically.
5.1.1
Protection against unauthorized access
epBlue GxP secures access to epBlue GxP by means of the following functions:
• Locking the epBlue GxP window if the logged in user has not performed any actions within a defined
time.
• Locking user accounts if an incorrect password has been repeatedly entered.
• Optional: Restricting the validity of user accounts to a specific time period; see the software operating
manual.
• Optional: Restricting the validity of passwords to a specific time period.
• Complex rules for passwords.
19
20
Basic concepts
epBlue GxP™
English (EN)
5.1.2
Rules for passwords
The following rules apply to passwords:
• A length of at least six characters.
• At least one uppercase letter.
• At least one lowercase letter.
• At least one digit.
• At least one special character.
5.2
Electronic documents
Electronic documents constitute data that has a digital signature.
The following data can be saved as electronic documents:
• Applications
• Logs of applications with the status authorized
epBlue GxP saves electronic documents and signatures in the epBlue database. Electronic documents
cannot be deleted from epBlue GxP. Electronic documents can be archived.
5.2.1
Digital signatures
epBlue GxP creates digital signatures in accordance with the Digital Signature Algorithm (DSA)
standardized procedure.
If electronic documents are used, epBlue GxP verifies whether the signatures are valid. If a signed
document has been changed, its signature becomes invalid. epBlue GxP displays an error message.
In order to sign a document, you have to enter your name and your password.
Basic concepts
epBlue GxP™
English (EN)
5.2.2
Status of electronic documents
Each signature has a meaning.
The status of an electronic document depends on the status and number of assigned signatures. An
electronic document has a maximum of three signatures with a different status and can be signed by a
maximum of three users.
Tab. 5-1:
Status of electronic documents
Status:
Number of
signatures
none
1
2
Significance for
applications
Each new
document created
has the status
unsigned.
The signer confirms
that he has created
and tested the
application.
The signer confirms The signer
that he has
authorizes the
reviewed the
application for use.
application.
The signer confirms
that he has
executed the run
per specification.
The signer confirms
that he has
reviewed the run
per specification.
Significance for
logs
1, 2 or 3
The signer
authorizes the log
and thus the run.
He thus releases,
for example, edited
samples.
The Administrator specifies the number and status of signatures that are required for authorizing a
document. The number and status of signatures are separately specified for applications and logs.
epBlue GxP enforces the "concept of multiple review". A document can be only be signed once by a user.
The user group to which a user belongs determines whether he is authorized to assign signatures with a
specific status.
5.2.3
Revisions
epBlue GxP automatically manages the revisions of signed applications. This allows epBlue GxP to
document the development of the applications.
•
•
•
•
•
•
The status of an application refers to a revision.
Revisions of an application can have different statuses.
If you change and save a signed application, epBlue GxP creates a new unsigned revision.
Older revisions can be read, but not changed.
Revisions can be executed until a newer revision is signed as authorized.
Logs are recorded for each revision.
21
22
Basic concepts
epBlue GxP™
English (EN)
5.2.4
Handling of signed applications
An application is signed if the current revision has a signature.
Tab. 5-2:
The following restrictions apply to signed applications:
Editing
• epBlue GxP creates a new revision when you edit and save the
application.
• This can be avoided by saving the changed application under a new
name.
• The properties of a signed application cannot be changed.
Labware
• epBlue GxP saves a copy of the labware used together with the signed
application.
• This ensures that signed applications can be executed if the labware
library has been changed.
• A signed application is always performed with the labware that is
saved in the application.
Execution
• If an application is executed, the user cannot change the preset Level
Sensor Options.
Administration
• The application cannot be deleted. The application needs to be
archived in order to remove it from the system.
• The Cut function is not available.
• If you copy the application, the signatures are not copied with it. Sign
the applications after they have been copied.
• If you export the application, the signatures are not copied with it.
• Folders containing signed applications cannot be deleted or renamed.
• User accounts under which signed applications are saved cannot be
deleted.
5.2.5
Digital key pair
If a new user account is created, epBlue GxP calculates an individual digital key pair and saves it in the
epBlue database. The digital key pair consists of a private and a public key.
The private key is protected by the password for the user account. The private key is used to generate
digital signatures.
The public key is used to verify digital signatures of documents. The documents can be contained in the
epBlue database and exist as a PDF document.
Basic concepts
epBlue GxP™
English (EN)
5.2.6
Certificates
A system signature can be used to prove that a PDF document was generated by epBlue GxP (authenticity)
and that it has not been changed after it was exported.
The system signature is valid for one epBlue system. The system signature is identical for all PDF
documents originating from this epBlue system.
As soon as an electronic document is opened in epBlue GxP, the digital signature is verified. To verify the
validity of the signatures in PDF documents, export the public keys together with the information about the
user as PKCS#7 certificates (.cer files) from epBlue.
Exported certificates can be used to verify created PDF documents and signatures contained therein.
Tab. 5-3:
Verification of PDF documents and signatures contained therein
Certificate
Description
User certificate
This certificate is used to verify the validity of the digital signature of the
user who exported the document from epBlue GxP.
It provides proof that the document exported by a specific person has not
been tampered with.
System certificate
This certificate is used to verify the validity of the digital signature of the
epBlue system that was used to create the document.
It provides proof that the document was exported using a specific epBlue
system.
Master certificate
This certificate is used to verify the validity of user certificates and system
certificates that are used to check the document.
It provides proof that the digital signatures were generated by
epBlue GxP.
The master certificate is the root certificate of the system certificates and
the user certificates.
23
24
Basic concepts
epBlue GxP™
English (EN)
5.3
Audit trail
The audit trail is recorded chronologically.
An audit trail saves the following information:
• Changes to applications and labware.
• Signature of data.
• Execution, interruption and termination of applications.
• State of and changes to the system configuration.
• User logins and logouts.
• Changes to user accounts.
The audit trail is part of the documentation. The audit trail can be exported as a signed PDF document.
5.3.1
Providing a reason for actions
Abb. 5-1: Entering a reason
Fig. 5-1:
Entering a reason
You are required to provide a reason for actions that change the system configuration or the data file.
epBlue GxP saves the reason together with the data of the action in the audit trail.
Installation
epBlue GxP™
English (EN)
6
6.1
Installation
Requesting a GxP activation license
If you have ordered an epBlue GxP upgrade kit, you will need to activate the epBlue GxP
software with the activation license.
If you have ordered an epMotion with epBlue GxP, the activation license will already have
been loaded into the software at Eppendorf.
Prerequisites
•
•
•
•
epMotion and MultiCon PC have been installed by an authorized technician.
A USB storage medium is connected to the MultiCon PC.
epBlue GxP has been started.
A user belonging to the user group Administrator or Administrator Lab is logged in.
1. Click on the Setting symbol.
2. Select the License Management tab.
3. Press the Show computer information button.
The Computer Identity Information window appears.
Abb. 6-1: Computer Identity Information window
Fig. 6-1:
Computer Identity Information window
4. Press the Save to file button.
5. Select the folder on the USB storage medium.
6. Press the Save button.
A text file with the computer identity information is saved.
7. Access the website www.eppendorf.com/software-licensing.
8. Sign up on the website.
9. Copy the contents of the text file from the USB storage medium to the field provided on the website.
You will receive the GxP activation license in an e-mail within 48 hours.
25
26
Installation
epBlue GxP™
English (EN)
6.2
Importing the activation license
Prerequisites
• A USB storage medium with the activation license is connected to the MultiCon PC.
• A user belonging to the user group Administrator or Administrator Lab is logged in.
• The License Management tab in the Settings area is opened.
1. Press the Open license file button.
2. The Open Eppendorf License window appears.
3. Select the activation license on the USB storage medium.
4. Press the Open button.
The activation license is inserted into the software.
5. Restart the epBlue GxP.
6.3
Setting up the system
6.3.1
Logging in as an administrator
In epBlue GxP, a user account belonging to the user group Administrator has been installed. This user
account is used to set up the software.
Abb. 6-2: Welcome to epBlue window
Fig. 6-2:
Welcome to epBlue window
1. Start epBlue GxP.
The Welcome to epBlue window appears.
2. Log into epBlue GxP:
• Username: Administrator
• Password: Admin123!
You are logged in as administrator.
Installation
epBlue GxP™
English (EN)
6.3.2
Configuring epBlue GxP
epBlue GxP offers an advanced user management to facilitate GxP-compliant mapping of laboratory
processes and structures.
Only a user belonging to the user group Administrator is authorized to configure epBlue GxP.
Make the following settings before you start to work with epBlue GxP:
 Change the password for the user account Administrator.
Be sure to keep the new password in a safe place.
 Set up the user accounts.
 Set the security for the user accounts.
 Set the signature rights for the user accounts.
 Set the authorization scheme of applications and logs.
27
28
Installation
epBlue GxP™
English (EN)
Operation
epBlue GxP™
English (EN)
7
7.1
Operation
Login and changing the password
7.1.1
Logging into epBlue GxP
Abb. 7-1: Welcome to epBlue window
Fig. 7-1:
Welcome to epBlue window
1. Start epBlue GxP.
The Welcome to epBlue window appears.
2. Enter your name and password.
3. Press the Login button.
You are now logged into epBlue GxP.
7.1.2
Unlocking epBlue GxP
epBlue GxP will be locked if you do not make any entries for a defined time.
Abb. 7-2: Unlocking epBlue GxP
Fig. 7-2:
Unlocking epBlue GxP
 Enter the password of the logged-in user in the Unlock window.
If you repeatedly fail to enter the correct password when trying to unlock epBlue GxP, the user account
will not be locked.
29
30
Operation
epBlue GxP™
English (EN)
7.1.3
Changing your own password
If your password has expired or you would like to change your password, you can assign a new password
yourself.
If you have forgotten your password or your user account has been locked, a user belonging to the user
group Administrator will need to assign a new password.
Abb. 7-3: Changing your own password
Fig. 7-3:
Changing your own password
Prerequisites
• You are logged into epBlue GxP.
1. In the Settings area, click on the Account Management > Edit own account tab.
2. In the Users column, select the user account.
3. Press the Change Password button.
4. Enter your password in the Old Password field.
5. Enter your new password in the New Password field.
6. Re-enter your password in the Confirm Password field.
7. Press the Submit button to save your entries.
7.2
Using digital signatures
7.2.1
Signing applications
Signatures refer to a revision.
If a revision does not have the status authorized, you can subsequently sign the revision.
Each signature has a meaning. A meaning can be assigned to each revision once only. The meanings which
are available depend on the signatures which the revision already has.
The signatures which the user can assign depend on the user group to which the user belongs.
A user who is not logged into epBlue GxP can execute a signature.
Operation
epBlue GxP™
English (EN)
Abb. 7-4: Applications in the Application Editor
Fig. 7-4:
Applications in the Application Editor
Sign a revision as follows:
1. In epBlue GxP, open the Application Editor area.
2. Select the application.
3. In the Revision area, select the revision.
4. Click on the
in the menu bar.
The application is opened.
5. Click on the
symbol in the menu bar.
The Sign window opens.
If the revision has signatures, the signatures will appear in the Sign window.
Abb. 7-5: Sign window
Fig. 7-5:
Sign window
6. Click on the Sign button.
The Sign window opens.
31
32
Operation
epBlue GxP™
English (EN)
Abb. 7-6: Sign window
Fig. 7-6:
Sign window
User Identification
Name of the signing user
Meaning
Meaning of the signature
Password
Password of the signing user
Description
Description of the signature
7. Complete the fields in the Sign window.
8. Click on the Sign button to save the signature.
The signature appears in the Sign window.
Abb. 7-7: Revision with signature
Fig. 7-7:
Revision with signature
9. Click on the Sign button to add more signatures. Repeat the steps described.
10. Close the window. To do this, click on the OK button.
Operation
epBlue GxP™
English (EN)
7.2.2
Signing logs
Abb. 7-8: Sign Logfile window
Fig. 7-8:
Sign Logfile window
Prerequisites
• The revision has the status authorized.
1. Start an application with the status authorized.
The application is executed. If the application is ended or aborted, the Sign Logfile window opens.
2. Click on the Sign button.
The Sign window opens.
3. Complete the fields as described in the chapter Signing applications, (see p. 30).
4. Click on the Sign button.
The signature appears in the Sign window.
5. To close the Sign Logfile window, click on the OK button.
7.2.3
Managing revisions
epBlue GxP has a revision management for applications. The revisions document the development of the
application.
7.2.3.1 Opening the current revision
You can change current revisions.
1. In epBlue GxP, open the Application Editor area.
2. Select the application.
3. Click on the Open application symbol
The current revision of the application is opened.
33
34
Operation
epBlue GxP™
English (EN)
7.2.3.2 Opening any revision
You can open any revisions.
Older revisions cannot be changed and are opened with read-only status. Older revisions can be executed
until the current revision has the status authorized.
Abb. 7-9: Opening a revision
Fig. 7-9:
Opening a revision
1. In epBlue GxP, open the Application Editor area.
2. Select the application.
3. In the Revision area, select the revision.
4. Click on the
symbol in the menu bar.
The revision is opened.
The Open Applications column displays the revisions.
Abb. 7-10: Information about the opened application
Fig. 7-10: Information about the opened application
7.2.3.3 Creating a new revision
Signed applications are read-only and cannot be changed. To change a signed application, you have to
create a new revision.
Create a new revision as follows:
Prerequisites
• The current revision has at least one signature.
1. In epBlue GxP, open the Application Editor area.
2. Select the application.
3. In the Revision area, select the revision.
4. Click on the Open application symbol.
The revision is opened.
Operation
epBlue GxP™
English (EN)
5. Click on the
symbol in the menu bar.
A new unsigned revision is created.
6. Change the application.
If you have changed a signed revision, labware conflicts may occur (see Changing signed applications on
p. 38).
7. Click on the Save button to save the revision.
8. Enter a reason for the changes to the application.
9. Press the OK button.
You have created a new unsigned revision.
7.2.4
Signatures
7.2.4.1 Displaying signatures of applications
Abb. 7-11: Sign window
Fig. 7-11: Sign window
1. In epBlue GxP, open the Application Editor area.
2. Select the application.
3. In the Revision area, select the revision.
4. Click on the Open application symbol.
The revision is opened.
5. Click on the Sign symbol in the menu bar.
The Sign window opens.
35
36
Operation
epBlue GxP™
English (EN)
7.2.4.2 Displaying signatures of logs
Abb. 7-12: Saved logs in the Log Viewer window
Fig. 7-12: Saved logs in the Log Viewer window
1. In epBlue GxP, open the Log Viewer area.
2. Select the application.
3. In the Revision area, select the revision.
4. Click on the
symbol in the menu bar.
The logs that belong to the selected application are opened.
5. In the Stored logs area, select the log.
6. Click on the Show signatures symbol.
7. The Sign window opens.
Abb. 7-13: Signatures of a log
Fig. 7-13: Signatures of a log
Operation
epBlue GxP™
English (EN)
7.2.4.3 Verifying signatures
If a signature is valid, the document has not been changed after it was signed. If the signature of an
application is valid, the labware used has not been changed.
An invalid signature indicates that the application was manipulated.
Abb. 7-14: Sign window
Fig. 7-14: Sign window
Date
Date and time of signing
Description
Status of the signature.
Name
Name of the user who signed the document.
Valid
Validity of the signature:
Signature is VALID.
Signature is INVALID.
Meaning
Meaning of the signature
Prerequisites
• The Sign window is open.
 Verify the signatures.
Each line corresponds to a signature. If the document does not have any signatures, the window is
empty.
37
38
Operation
epBlue GxP™
English (EN)
7.2.5
Signatures in applications and logs
Printouts of applications and logs contain the status and validity of the signature.
Abb. 7-15: Information about the signature in the printout
Fig. 7-15: Information about the signature in the printout
7.3
Labware in signed applications
epBlue GxP saves a snapshot of the labware used together with the signed application. Signed applications
can be executed, even if the labware is changed in the labware library. The signed application is executed
with the labware snapshot that is saved in the application.
7.3.1
Changing signed applications
When you create a new revision of a signed application, epBlue GxP uses the labware snapshot in the
revision and compares it with the labware in the labware library. If the labware from which the snapshot
was created has been changed or deleted in the labware library, a labware conflict will occur. epBlue GxP
offers various solutions for labware conflicts.
Abb. 7-16: Labware conflicts window
Fig. 7-16: Labware conflicts window
Conflicts column
Labware conflict.
Snapshot labware column
Properties of the labware used in the signed application.
Options column
Library labware column
Options for resolving the labware conflict.
Properties of the labware snapshot.
Operation
epBlue GxP™
English (EN)
Creating a new revision
1. Create a new revision of the application.
2. Alternatively, save the application under a different name.
If a labware conflict occurs, the Labware conflicts window appears. In this window, epBlue GxP shows
problems and solutions for the labware conflict.
Resolving a labware conflict
3. Select the option to be used to resolve the labware conflict.
Option for resolving the labware Description
conflict
Rename and add labware to library
• Under the name there is labware with the same name but different
properties.
• The labware snapshot is added to the labware library as new
labware.
• A name must be assigned for the new labware.
• The labware snapshot is used in the new revision.
• All patterns used in the application remain valid.
• The application remains executable without any changes.
Add labware to library
•
•
•
•
•
Use library labware
• The labware snapshot is replaced by labware from the labware
library.
• If the labware snapshot and the labware in the labware library are
different, patterns become invalid.
• If the labware snapshot and the labware in the labware library are
different, the application can no longer be executed without
changes.
Delete from application
• The labware snapshot is deleted.
• Patterns become invalid.
• The application can no longer be executed without changes.
No labware exists under the name.
The labware snapshot is added to the labware library.
The labware snapshot is used in the new revision.
All patterns used in the application remain valid.
The application remains executable without any changes.
39
40
Operation
epBlue GxP™
English (EN)
7.4
Working with signed PDF documents
Digitally signed PDF documents contain the system signature and the signature of the user who exported
the PDF documents as well as the associated certificates. The digital signature is inextricably embedded in
the PDF document as encrypted code.
epBlue GxP exports digitally signed PDF documents consisting of the following data:
• Signed applications
• Signed logs
• Audit trail
• IQ
• Archives consisting of applications, logs and labware used therein
Data in the database is not changed when it is exported.
7.4.1
Exporting data as signed PDF documents
Prerequisites
• You are logged into epBlue GxP as Administrator or Administrator Lab.
• The database contains applications and logs with a signature.
1. Select the area containing the data to be exported.
Applications
Logs
Audit Trail
IQ
Application Editor area
Log Viewer area
Audit Trail Viewer area
Settings > Devices area
2. Select the data.
3. Click on the
symbol in the menu bar.
The print preview opens.
4. Press the
button.
The Sign window appears.
Abb. 7-17: Sign window
Fig. 7-17: Sign window
Password
The password of the user.
Description
Enter a reason for exporting the data.
Operation
epBlue GxP™
English (EN)
5. If the PDF document is not to be signed, click on the Cancel button.
6. In order to sign the PDF document, click on the Sign button.
7. Select where the PDF document should be saved.
8. Click on the Save button.
7.4.2
Exporting digital certificates from epBlue GxP
Exported digital certificates are required in order to verify the signatures in PDF documents.
The master certificate is also located on the website www.eppendorf.com/automation.
Abb. 7-18: Certificates window
Fig. 7-18: Certificates window
Prerequisites
• You are logged into epBlue GxP as Administrator.
1. Open the Settings area.
2. On the GxP tab, click on the Certificates entry.
3. In the Certificates area, select the certificates to be exported.
Master
The master certificate is exported.
System
The system certificate is exported.
All
The certificates of all users, the master certificate and the system certificate are
exported.
The certificates of disabled and deleted user accounts are exported.
4. Click on the Export button.
The Browse For Folder window opens.
5. Select where the certificates should be saved. Click on the OK button.
Each certificate is saved in the format PKCS#7 (*.cer).
If a user belonging to the user group Administrator has changed the password of a user
account, several digital certificates are exported for this user account. You need all the digital
certificates in order to verify the user's signatures before and after the password was changed.
 Archive all the digital certificates of a user.
41
42
Operation
epBlue GxP™
English (EN)
7.4.3
Importing the master certificate into the PDF reader
To check the validity of signatures and certificates in a PDF reader, you need to export the master
certificate from epBlue GxP and import it to the PDF reader.
The master certificate is the root certificate of epBlue GxP. The system certificate and the certificates of the
users are signed with the master certificate.
Handling certificates is different in each PDF reader. Details can be found in the instructions
for your PDF reader.
Many PDF readers trust certificates that come from a trusted root certificate, such as Adobe
Reader.
If your PDF reader trusts the master certificate, proceed as follows to import the master certificate.
Prerequisites
• The master certificate is located in the file MasterCertificate.cer (see Certificates on p. 23).
• The PDF reader supports certificates in the format PKCS #7.
1. Import the MasterCertificate.cer file to the PDF reader.
The master certificate was imported using the name Eppendorf epBlue CA.
2. Check the master certificate.
The checksums must match the following character string. The character string may contain uppercase
or lowercase letters.
Tab. 7-1:
Checksum for character strings
SHA1 digest
9E B7 33 3D 2A 8D 16 D3 82 C4 01 B8 AD A2 8B FF BF B8 87 70
MD5 digest
47 90 88 69 77 44 B2 DB A2 AE 41 29 FF 1C EF 59
3. In order to verify signatures in PDF documents from epBlue GxP, specify the following setting.
• Use the master certificate as a trusted root certificate.
• Trust the master certificate for the signature of documents.
• Trust the master certificate for certifying documents.
Abb. 7-19: Master certificate settings in Adobe Reader
Fig. 7-19: Master certificate settings in Adobe Reader
Operation
epBlue GxP™
English (EN)
7.4.4
Verifying signatures and certificates in PDF documents.
In order to verify signatures, you can use any PDF reader that supports PKCS #7 certificates. Working with
Adobe Reader 9 is shown below.
Prerequisites
• The master certificate has been imported into the PDF reader (see Importing the master certificate into
the PDF reader on p. 42).
1. Open the PDF document.
2. Click on the Signature Panel button.
Abb. 7-20: Certificate in the Adobe Reader
Fig. 7-20: Certificate in the Adobe Reader
3. Check the validity of the signatures.
4. In order to view embedded certificates, click on the Certificate Details... button.
The signatures are valid if the document has been exported by the signatory user from epBlue GxP
(authenticity) and the document has not been changed (integrity).
43
44
Operation
epBlue GxP™
English (EN)
7.5
Audit trail
Abb. 7-21: Audit trail
Fig. 7-21: Audit trail
The time stamp displays the time according to the time zone set in the operating system
configuration. If the time zone is changed, the time stamps will be automatically adjusted. The
set time zone is included in the audit trail printout.
7.5.1
Opening the audit trail
 In epBlue GxP, open the AuditTrail Viewer area.
The audit trail is displayed as a table. Each line shows an entry.
7.5.2
Displaying the details of an entry
 Select the entry in the table.
The details appear in the Selected entry area.
7.5.3
Sorting entries
1. Click on the column header by which sorting should be performed.
The table is sorted in ascending order.
2. Click on the column header again to sort in descending order.
Operation
epBlue GxP™
English (EN)
7.5.4
Creating a filter
1. Click on the New Filter symbol.
The Filter window appears.
2. Specify the filter name.
3. Define the filter criteria.
4. Use the Add button to add more filter criteria.
5. Press the Save button to save the filter.
7.5.5
Editing a filter
1. Click on the Edit Filter symbol.
The Filter window appears.
2. Change the filter name, if relevant.
3. Change the filter criteria.
Use the Add button to add filter criteria.
Use the Remove button to delete filter criteria
4. Press the Save button to save the filter.
7.5.6
Selecting a filter
 Select the filter in the drop-down menu of the menu bar.
The audit trail is adapted to the filter.
7.5.7
Deleting a filter
1. Select the filter in the drop-down menu of the menu bar.
The audit trail is adapted to the filter.
2. Press the Trash symbol to delete the opened filter.
7.5.8
Selecting columns to be displayed
 Open the Select Visible Columns drop-down menu.
 Select the columns to be displayed.
7.5.9
Printing and exporting the audit trail
You can print the displayed part of the audit trail or export it as a PDF document.
1. Access the audit trail.
2. Select a filter, if relevant.
3. Press the
symbol.
The print preview opens.
4. Click on the
symbol in the print preview to print the audit trail.
5. Press the
button in the print preview to export the audit trail as a PDF document.
45
46
Operation
epBlue GxP™
English (EN)
7.5.10
Audit trail categories
The audit trail saves events as entries. Each event that receives an entry is assigned to a category.
Tab. 7-2:
Changing the user data
Category
Event
New Application
Application Changed
Application Deleted
Application Saved Under
New Name
Application Imported
Application Exported
Application Printed
• The user has created a new application.
• The user has changed or deleted an existing unsigned application or
saved it under a new name.
• The user has imported or exported an application.
• The user has printed an application or exported it as a PDF document.
Old Application Updated
• In the Application Editor the user has confirmed the action of updating an
imported application that was created with an older software version.
Official Application Changed
Official Application Copied
• The user has changed a signed application and thus created a new
unsigned revision.
• The user has copied a signed application.
Application Signed
Application Authorized
• The user has signed an application as created or reviewed.
• The user has signed an application as authorized.
Application Log Printed
• The user has printed a log or exported it as a PDF document.
Labware Created
Labware Changed
Labware Deleted
Labware Copied
Labware Imported
Labware Exported
Labware Printed
•
•
•
•
ID List Created
ID List Exported
ID List Removed
Archive
The user has created new labware.
The user has changed, deleted or copied existing labware.
The user has imported or exported labware.
The user has printed labware or exported it as a PDF document.
epBlueID
• The user has created an ID list. The ID list was created when importing a
file or when executing an application with ID tracking.
• The user has exported an ID list.
• The user has removed an ID list.
• A user belonging to the user group Administrator has archived one or
more applications or parts of the audit trail.
Operation
epBlue GxP™
English (EN)
Tab. 7-3:
Executing applications
Category
Event
Application Started
Application Ended
• The user has started an application.
• An application has been ended.
Number of Samples
• The user has manually entered the number of samples for an application.
Application Stopped
Single-Step Application
Continue Application
• The user has stopped an application.
• The user has executed a step in the stopped run.
• An application has been continued.
Application Error
• An error has occurred during an application.
Application Aborted
• An application has been aborted.
Tab. 7-4:
User accounts and user actions
Category
Event
Login
Logout
• A user has logged into epBlue GxP or logged out.
Idle Session Blocked
Idle Session Unblocked
• epBlue GxP has been locked. The user has not made any entries for a
defined period of time.
• A user has unlocked epBlue GxP by entering his password.
User Added
User Deleted
User Group Changed
Password Changed
• A user belonging to the user group Administrator has created a new user
account or deleted a user account.
• A user belonging to the user group Administrator has assigned a user
account to another user group.
• A user has changed his password or a user belonging to the user group
Administrator has set a new password for a user.
False Login User Disabled
• The user has repeatedly entered an incorrect password. The user account
has been locked.
Disabled User Reactivated
• A user belonging to the user group Administrator has unlocked a locked
user account.
Password Expired
• The validity of a password has expired.
Account Expired
• The validity of a user account has expired.
47
48
Operation
epBlue GxP™
English (EN)
Tab. 7-5:
Setting and changing the system
Category
Event
Device Found
Device Added
Device Lost
• epBlue GxP has detected a connected device.
• epBlue GxP has detected an epMotion 5075 and added it to the selection.
• The communication between epBlue GxP and an epMotion 5075 has
been interrupted.
Device Initialization Failed
• epBlue GxP was unable to initialize a connected device.
Device Status Changed
• The status of the device has changed, for example, an application has
been started or stopped.
Device Firmware Update
• A user belonging to the user group Administrator Lab or Service has
installed another firmware version of epMotion 5075.
Barcode Settings Changed
epBlueID
• A user belonging to the user group Administrator Lab has changed the
barcode reader settings.
Number of Reagent IDs
epBlueID
• A user belonging to the user group Administrator Lab has changed the
Changed
number of required IDs or barcodes for reagents.
Import/Export Settings for ID
• A user belonging to the user group Administrator Lab has changed the file
List Changed
format or the storage location for the import or export of ID lists.
Checksum Settings Changed epBlueID
• A user belonging to the user group Administrator or Administrator Lab
has changed the setting for the checksum validation of ID lists or CSV
files.
Number of Authorization
Signatures
• A user belonging to the user group Administrator has changed the
authorization scheme of applications or logs.
Password Lifetime Changed
Maximum Login Retries
Changed
Max Idle Time Changed
• A user belonging to the user group Administrator has changed the
duration of the validity of user account passwords.
• A user belonging to the user group Administrator has changed the
number of failed logins after which a user account is locked.
• A user belonging to the user group Administrator has changed the time
after which a user account is locked when the user has not performed any
actions.
Auto Backup
Database Successfully
Restored
• epBlue GxP has automatically saved the database. An error has occurred
during the automatic backup.
• A user belonging to the user group Administrator has restored the epBlue
database from a backup.
Dialog Message
• epBlue GxP has displayed a message.
epBlue Application Error
• An error has occurred while creating a digital signature.
• A software error has occurred.
Device Configuration
Changed
Service Function
• Authorized service personnel have changed the configuration of the
device.
• Authorized service personnel have performed a test function or changed
a setting of the device.
Operation
epBlue GxP™
English (EN)
7.6
Creating and validating checksums
Checksums are used to validate files that are exchanged between epBlue GxP and other programs. This
ensures errors are detected when data is transferred or if data is manipulated. You can validate the
checksum of files when importing to epBlue GxP or in external software.
7.6.1
Importing and validating files with checksums
epBlue GxP cannot validate the checksums of files if the files have the format zip, dws, lhs and
ws and originate from older versions of epBlue GxP or from the epMotion 5075 Control Panel.
If you import the following data, epBlue GxP validates the checksums.
File format
Application
Checksum
.export
• Applications
• Labware
• The checksum is always validated.
.csv
• Applications
• ID lists
.xml
• ID lists
• If checksum validation has been enabled, epBlue GxP validates the
checksum.
• If checksum validation has not been enabled, epBlue GxP ignores an
existing checksum.
Prerequisites
• Checksum validation has been enabled.
 Files are imported as described in the software operating manual.
If the checksum has been validated successfully, the file is imported.
If the checksum is invalid or no checksum is present, a warning message appears.
7.6.2
Tab. 7-6:
Exporting files with checksums
Files that have a checksum after the export from epBlue GxP
File format
File
.export
• Application
• Labware
.csv
• ID List
.xml
• ID List
 Files are exported as described in the software operating manual.
49
50
Operation
epBlue GxP™
English (EN)
7.6.3
Validating checksums in external software
Proceed as follows to validate a checksum from epBlue GxP:
1. Save the checksum.
2. In the imported file, delete the line containing the checksum.
3. Delete line breaks in the file.
4. Calculate the checksum for the file using the SHA256 algorithm.
The algorithm is included in the Microsoft .NET Framework.
5. Compare the calculated checksum with the saved checksum.
7.6.4
Creating checksums in external software
The checksums must be created as follows for epBlue GxP to be able to validate the checksums during the
import.
1. To calculate the checksum, remove the line breaks.
2. Calculate the checksum using the SHA256 algorithm.
This algorithm is included in the Microsoft .NET Framework.
3. Enter the checksum in the file.
Tab. 7-7:
Checksums for certain file formats
CSV file
In line 5, column 1 = checksum, column 2 = calculated checksum
XML file
In <Checksum> tag under <ID_List>
Abb. 7-22: ID list in format csv with checksum
Fig. 7-22: ID list in format csv with checksum
Operation
epBlue GxP™
English (EN)
Abb. 7-23: ID list in format xml with checksum
Fig. 7-23: ID list in format xml with checksum
51
52
Operation
epBlue GxP™
English (EN)
Administration
epBlue GxP™
English (EN)
8
Administration
epBlue GxP can only be managed by a user belonging to the user group Administrator.
NOTICE! Data loss due to lost password for a user account belonging to the user group
Administrator.
If you no longer have the password for a user account belonging to the user group
Administrator, the system will have to be reinstalled.
 Install at least two user accounts belonging to the user group Administrator.
8.1
Expanded user administration
8.1.1
Setting the security of user accounts
Prerequisites
• You are logged in as administrator.
1. In epBlue GxP, open the Settings area.
2. Open the Account Management tab.
3. In the Navigation column, click on the Account Settings entry.
Abb. 8-1: Security settings for user accounts
Fig. 8-1:
Security settings for user accounts
Period of validity for passwords
Lock application after user inactivity
Validity of the passwords in days.
Set the number of minutes after which
Change the password after the period of validity has expired.
epBlue GxP is locked.
If you enter the value, the passwords are valid for an
If no entries are made within the
unlimited period of time.
defined time, epBlue GxP will be
locked.
Allowed maximum number of login retries
Number of failed logins.
If the number of failed logins is exceeded, epBlue GxP will
lock the user account.
User accounts belonging to the user group Administrator will
not be locked.
53
54
Administration
epBlue GxP™
English (EN)
4. Click on the Apply button to apply the settings.
5. Click on the Reset button to discard the settings.
The Please enter reason window appears.
6. Enter a reason for the change.
The reason appears in the audit trail.
Information how to set up user accounts can be found in the software operating manual.
8.1.2
Configuring the authorization scheme
Specify how many signatures are needed by applications and logs in order to obtain the status authorized.
Prerequisites
• You are logged in as administrator.
1. Click on the Settings area.
2. Open the GxP tab.
3. In the Navigation column, select the Signatures field.
Abb. 8-2: Configuring the authorization scheme
Fig. 8-2:
Configuring the authorization scheme
4. Select the authorization scheme for applications from the Applications drop-down menu.
5. Select the authorization scheme for logs from the Logfiles drop-down menu.
Tab. 8-1:
Authorization scheme
Authorization scheme
Final status of document
Number of signatures
Number of users
Create -> Review -> Authorize
Authorized
One signature each with 3 different users
the meaning Created,
Reviewed and Authorized
Create > Authorize
Authorized
One signature each with 2 different users
the meaning Created and
Authorized
Authorize
Authorized
One signature with the
meaning Authorized
1 user
Administration
epBlue GxP™
English (EN)
6. Click on the Reset button to delete the settings.
7. Click on the Apply button to apply the settings.
If you apply the settings, the Please enter reason window opens.
8. Enter a reason. Confirm your entry with the OK button.
The reason appears in the audit trail.
8.1.3
Defining signature rights
Each user group has defined rights for signing files.
User group
Signing applications Signing logs
Signing PDF documents
Guest
–
–
–
User Level 1
• Created
• Created
–
User Level 2
• Created
• Reviewed
• Created
• Reviewed
–
Administrator Lab
• Created
• Reviewed
• Authorized
• Created
• Reviewed
• Authorized
Administrator
–
–
• Archive
• Exported PDF documents of
applications and logs
• IQ
Archive
 Click on the Account Management area to display the signature rights.
 On the Account Management tab, click on the Group Overview field.
8.1.4
Unlocking a user account
epBlue GxP locks the user account in the following situations:
• The user repeatedly enters an incorrect password when logging into epBlue GxP.
epBlue GxP does not lock the user account in the following situations:
• The user repeatedly enters an incorrect password when unlocking epBlue GxP.
• The user account belonging to the user group Administrator is never locked.
Proceed as follows to unlock user accounts.
Prerequisites
• You are logged in as administrator.
1. Open the Settings area.
2. On the Account Management tab, click on the Account Management field.
3. In the Users area, select the locked user account.
55
56
Administration
epBlue GxP™
English (EN)
Abb. 8-3: Unlocking a user account
Fig. 8-3:
Unlocking a user account
4. Click on the Administrate field.
5. Enter a new password for the user account.
6. Click on the Submit button.
The user account is unlocked. The user can log in with the new password.
8.1.5
Deleting a user account
Once you delete a user account, it is not possible to create a new user account with the same name. In this
way, the system ensures that user names are unique.
After you delete a user account, the signatures made by the deleted user continue to be valid. The digital
certificate of the deleted user account can be exported.
If signed applications are saved under a user account, it is not possible to delete the user account. To delete
the user account, archive all of the applications signed by the user.
Deleting a user account is documented in the audit trail. All deleted user accounts are listed under the tab
Former Accounts.
Proceed as follows to delete user accounts.
Prerequisites
• You are logged in as administrator.
• There are no signed applications saved under the user account to be deleted.
1. Open the Settings area.
2. On the Account Management tab, click on the Account Management field.
3. In the Users area, select the user account to be deleted.
4. Click on the Administrate button.
5. Click on the Remove button to confirm the deletion of the user account.
6. Enter a reason for the deletion. Confirm your entry with the OK button.
The reason appears in the audit trail.
Administration
epBlue GxP™
English (EN)
8.2
Enabling checksum validation
Abb. 8-4: Enabling checksum validation
Fig. 8-4:
Enabling checksum validation
Import of ID lists
Enable or disable the validation of checksums
when importing ID lists.
Import of CSV files in the application editor
Enable or disable the validation of checksums
when importing CSV files.
Proceed as follows to enable and disable checksum validation.
Prerequisites
• You are logged in as Administrator or Administrator Lab.
1. In epBlue GxP, open the Settings area.
2. Select the Account Management tab.
3. In the Navigation column, select the Checksum settings entry.
4. Select the settings for checksum validation.
8.3
Archiving data
You can archive data in the form of signed PDF documents. When archived, the data are removed from the
epBlue database.
The following data can be archived:
• Applications together with the associated logs
• Individual logs
• Parts of the audit trail
Archived PDF documents can be verified by digital signatures. To verify the digital signatures, export the
certificates from epBlue GxP. Keep the certificates together with the archived data.
You can print archived PDF documents.
57
58
Administration
epBlue GxP™
English (EN)
NOTICE! Deletion of data from the database during archiving.
When you archive data, epBlue exports the data as PDF documents. The data are removed
from the epBlue database.
Archived data cannot be reimported into the epBlue database.
 Do not archive any data that you still need.
8.3.1
Archiving applications and logs
The following data cannot be archived:
• Open applications together with the associated logs
• User account of the logged-in user
Abb. 8-5: Archive window
Fig. 8-5:
Archive window
Prerequisites
• You are logged in as Administrator or Administrator Lab.
1. In epBlue GxP open the Settings area.
2. Select the GxP tab.
3. In the Navigation column click on the Archive entry.
4. Select the folder to which the files should be archived.
5. Select the files to be archived.
To select multiple files, press the CTRL key or the Shift key while selecting the files with the mouse.
Administration
epBlue GxP™
English (EN)
Tab. 8-2:
Selecting files for archiving
All applications and logs All applications and logs All revisions and logs for Logs for a revision
belonging to a user
in a directory belonging an application
to a user
 Select the user's
 In the Application
name in the
Application Library
area.
Library in the user's
folder, select the
name of the directory.
 Select the name of
the application.
1. Select the revision
number in the
Revision area.
2. Select the logs in the
Logfiles area.
3. Click on the Archive button.
The Information window appears.
Abb. 8-6: Information window
Fig. 8-6:
Information window
4. To archive the selected data, tick the I have read and accepted the above directions checkbox.
5. Enter the password.
6. You have the option of entering a reason for archiving in the Reason field.
The reason entered will appear in the audit trail and on the certificate of the PDF documents.
7. Click on the Accept button.
The data is saved in the form of signed PDF documents in a ZIP archive. After archiving, the data is
deleted from the epBlue-database.
59
60
Administration
epBlue GxP™
English (EN)
8.3.2
Archiving the audit trail
Abb. 8-7: Selection for archiving the audit trail
Fig. 8-7:
Selection for archiving the audit trail
Prerequisites
• You are logged in as Administrator or Administrator Lab.
1. In epBlue GxP open the Settings area.
2. Select the GxP tab.
3. In the Navigation column click on the Archive entry.
4. Open the Audit Trail tab.
5. Select the folder to which the files should be archived.
6. In the End Date field specify the date until which the entries should be archived in the audit trail.
epBlue GxP shows which entries are archived.
7. Click on the Archive button.
The Information window opens.
8. Tick the I have read and accepted the above directions checkbox.
9. Enter the password.
10. You have the option of entering a reason for archiving.
The reason entered will appear in the audit trail and on the certificate of the PDF document.
11. Click on the Accept button.
The data is saved in the form of signed PDF documents. After archiving, the data is deleted from the
epBlue-database.
Administration
epBlue GxP™
English (EN)
8.4
Checking the system configuration
Authorized service personnel create a reference list (IQ Reference) during installation. The reference list
contains the configuration of relevant software and hardware components. The reference list is saved in the
system.
You can compare the current configuration with the reference list. This enables you to check which
components have been changed.
Proceed as follows:
Prerequisites
• You are logged in as Administrator or Administrator Lab.
1. In epBlue GxP open the Settings area.
2. Select the GxP tab.
3. In the Navigation column, click on the IQ/OQ entry.
Abb. 8-8: Checking the system configuration
Fig. 8-8:
Checking the system configuration
4. Click on the Compare reference button.
The system determines the current configuration of relevant software and hardware components and
compares it with the reference list.
The test report appears in the Preview window.
5. Print the test report if required or save it as a PDF document.
6. Close the Preview window.
61
62
Administration
epBlue GxP™
English (EN)
Abb. 8-9: Test report
Fig. 8-9:
Test report
Category
Description
Firmware
Firmware version of the device's assemblies.
PC software
epBlue GxP component versions.
Industrial computer
Other manufacturers' component versions used in epBlue GxP.
Configuration of operating system components.
epMotion
epMotion 5075 component versions.
epMotion 5075 serial number.
The test report consists of five categories. The Term column indicates which component criterion was
compared.
Deviations between the current configuration and the reference list are shown in red. Deviations are
marked with a red cross in the printout and in the PDF document.
Troubleshooting
epBlue GxP™
English (EN)
9
9.1
Troubleshooting
General errors
Additional troubleshooting instructions can be found in the software and hardware operating manuals.
Problem
Cause
Solution
No valid reference
file has been found.
Please contact
Eppendorf Service.
• The reference list for the Compare
Reference function has not been
created.
• The reference list for the Compare
Reference function is not legible.
• The reference list for the Compare
Reference function is not valid.
 Contact your authorized service
The signature of the
PDF document
cannot be verified.
• The master certificate has not been
imported into the PDF reader.
 Import the master certificate into the
• The PDF reader does not trust the
master certificate.
 Classify the master certificate as
center to have a new reference list
created.
PDF reader.
trusted.
A log cannot be
signed.
• A revision of the log does not have the 1. Sign the revision with the status
status authorized.
authorized.
2. Restart the application.
A log or an
application cannot
be signed.
• The user does not have the right to
assign the signature.
 Change the signature rights for logs
or applications.
 Assign the user to a different user
group.
An application
cannot be deleted.
• At least one revision of the application 1. Archive the application.
is signed.
2. Delete the application.
A user account
cannot be deleted.
• At least one signed application is
saved under the user account.
1. Archive the signed applications that
are saved under the user account.
2. Delete the user account.
When an
application is
started, the Levels
setting of the
optical sensor
cannot be changed.
• The started revision is signed.
 Change the settings of the optical
sensor as a user belonging to the user
group Administrator.
63
64
Troubleshooting
epBlue GxP™
English (EN)
Ordering information
epBlue GxP™
English (EN)
10
10.1
Ordering information
Accessories
Order no.
(International)
5075 002.507
5075 002.515
5075 002.523
5075 002.728
5075 002.701
Description
LH assistant
PCR assistant
designed to streamline and automate the whole PCR set-up workflow, like Compose
Mastermix, Normalize Concentrations, Create Dilution Series, Setup Reactions
Prep assistant
provide a step-by-step guided workflow of automated nucleic acid purification with
the MagSep reagent kits
epBlue GxP
Modification kit for epMotion with MultiCon PC as of serial number 4000
with documentation folder
epBlue ID
Modification kit for epMotion with MultiCon PC as of serial number 4000
with barcode reader
65
66
Index
epBlue GxP™
English (EN)
Index
D
A
Delete
User account ................................................... 56
Account settings....................................................53
Digital key pair...................................................... 22
Application
Administration .................................................22
Archive .............................................................58
Edit...................................................................22
Labware............................................................22
Digital signature ................................................... 20
Archive
Applications and logs.......................................58
Audit trail .........................................................60
Audit trail...............................................................24
Archive .............................................................60
Categories ........................................................46
Display .............................................................44
Entries ..................................................44, 44, 46
Export...............................................................45
Filter...............................................45, 45, 45, 45
Print .................................................................45
Reason for actions............................................24
Authorization scheme
Configuration ...................................................54
C
Certificate ..............................................................23
Checksum.........................................................42
Export...............................................................41
Import from external software .........................42
Master certificate .............................................23
Root certificate.................................................42
System certificate.......................................23, 23
Types of certificates .........................................23
Verify................................................................43
Change history
Operating manual ............................................11
Checksum ..............................................................49
Character string ...............................................42
Create in external software ..............................50
Disable validation.............................................57
Enable validation..............................................57
Export...............................................................49
Import ..............................................................49
Validate ............................................................49
Validate in external software ...........................50
E
Electronic document............................................. 20
Status............................................................... 21
epBlue
Configure ......................................................... 27
Unlock ............................................................. 29
epBlue GxP
Login................................................................ 29
Export
Audit trail......................................................... 45
Certificate ........................................................ 41
Checksum ........................................................ 49
Signed PDF document..................................... 40
H
History
Operating manual ............................................ 11
I
IQ compare
Check system configuration ............................ 61
K
Key
Private key ....................................................... 22
Public key ........................................................ 22
L
Labware
Lock labware ................................................... 22
Login
Log in as a user ............................................... 29
Log in as an administrator............................... 26
Logs
Archive............................................................. 58
Index
epBlue GxP™
English (EN)
M
U
Master certificate ............................................23, 42
Unlock
User account ................................................... 55
P
User account
Delete .............................................................. 56
Security settings .............................................. 53
Unlock ............................................................. 55
Password
Changing your own password .........................30
Rules ................................................................20
PDF document
Export...............................................................40
Signature..........................................................40
Signatures and certificates ..............................43
Protection against unauthorized access................19
R
Revision .................................................................21
Administration .................................................33
Change .............................................................34
New revision ....................................................34
Open any revision ............................................34
Open current revision ......................................33
Sign ..................................................................30
Rights of user groups ............................................19
Root certificate ......................................................42
S
Sign
Applications .....................................................30
Logs..................................................................33
Revisions ..........................................................30
Signature ...............................................................20
Applications .....................................................35
Authorization scheme ......................................54
Define signature right ......................................55
Handling of signed revisions ...........................22
Logs............................................................33, 36
Printouts of applications and logs....................38
Signed PDF document .....................................40
Verify....................................................35, 37, 43
View .................................................................35
Status
Electronic document ........................................21
System certificate ..................................................23
User group ............................................................ 19
Administrator................................................... 26
67
68
Index
epBlue GxP™
English (EN)
Evaluate Your Manual
Give us your feedback.
www.eppendorf.com/manualfeedback
Your local distributor: www.eppendorf.com/contact
Eppendorf AG · 22331 Hamburg · Germany
[email protected] · www.eppendorf.com
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertisement