Specifications

Specifications
Cerity Networked Data System
for Pharmaceutical QA/QC
Revision A.01.0x
Specifications
August 2002
Introduction
Cerity NDS for Pharmaceutical QA/QC is a networked data system
specifically designed for pharmaceutical QA/QC laboratories.
It is powerful, flexible and utilizes an integrated client-server
architecture enabling seamless industry standard distributed
client-server scalability. Its user interface is optimized to model the
way analysts work in the QA/QC environment, fully supporting their
everyday tasks. Cerity NDS for Pharmaceutical QA/QC is available
in two configurations, Cerity NDS for Pharmacuetical QA/QC
Professional and Cerity NDS for Pharmaceutical QA/QC Client/Server.
Overview
Cerity NDS for Pharmaceutical
QA/QC Professional
Cerity NDS Professional is the
solution for laboratories that
require instrument control, data
acquisition, data analysis, flexible
reporting and support for up to
8 chromatographs controlled by
a single computer with strict
adherence 21 CFR Part 11
(electronic records and electronic
signatures) and related predicate
rules such as to 21 CFR 210 (GMP)
and 21 CFR Part 211 (cGMP).
This configuration provides system
access for one user at a time. It is
designed for small laboratories
that require secure data storage,
data collection of electronic
analytical records, support for
several instruments without
the need for concurrent user
operations (figure 1)
Cerity NDS for Pharmaceutical
QA/QC Client/Server
The Client/Server configuration
extends the capabilities of Cerity
Professional by distributing
system tasks between the central
database server, any number of
connected instruments, acquisition
controllers and review client
workstations. This allows for
multiple users to access and
concurrently work with the central
database and any connected
instrument transparently from
any connected client workstation.
You can configure as many
clients as necessary on the Cerity
NDS cluster, considering any
licensing and resource limitations.
2
Figure 1
Cerity NDS for Pharmaceutical QA/QC Professional allows a single user to control, acquire and
process data from up to 8 dual channel instruments.
Figure 2
Example configuration of Cerity NDS for Pharmaceutical QA/QC Client/Server. One central Oracle
database server with two groups of instruments connected to dedicated acquisition controllers.
Users access the system through the connect client PCs.
General Description
The Cerity NDS uses the following
components to handle data
storage, data acquisition and
data processing and review:
• Review client – user interface
for sample entry, method
setup, instrument status
monitoring and results review
• Database server – data storage
and report generation
• Acquisition (reprocessing)
controller – instrument
control, data acquisition and
data processing/reprocessing
In the Cerity NDS Professional
system, all components are
installed on a single computer,
including the Oracle database.
In Cerity NDS for Pharmaceutical
QA/QC Client/Server, the
components may be installed
on separate computers in
order to distribute the load
on dedicated resources in a
distributed environment.
The underlying technical
infrastructure such as processes,
services and user interface
components are identical in
both configurations.
Central Data Repository
In a client/server environment,
the Cerity NDS database server
consists of a Windows NT server
hosting an Oracle database. This
is the central data repository of
the so-called Cerity cluster. The
cluster consists of all network
devices configured in the Cerity
NDS system. This includes the
database server, acquisition
controllers, instruments, printers,
client workstations and other
devices. All raw data (acquired
signals), meta-data (such as
methods, calibration information,
instrument serial numbers,
calculation formulae), and
calculated results are stored
centrally in the database along
with the computer-generated
audit trail information. Standard
queries allow searching, retrieving
and displaying data for review
and other purposes, such as
inspection, collation, sign-off and
reporting. The size of the database
depends on the number of
concurrent users, concurrent
instruments and the amount of
data online (accessible) in the
database.
Data Acquisition and Instrument Control
Acquisition Controllers and
Reprocessing Servers
The acquisition controller is
used to perform data acquisition
and instrument control. This
component controls instruments
that have been scheduled at
the review client to execute an
analysis using the specified
method. It collects and processes
the raw data and transmits it to
the central database server.
Acquisition controllers can
theoretically be used as review
clients. However, the background
processing load on the acquisition
controller typically decreases
system performance for
interactive use.
Agilent Instrument Driver
The suite of drivers to control
the supported instruments is
bundled with the Cerity NDS
software. The drivers for all
supported instruments are
installed with the base system.
The supported instruments are
the Agilent 1100 Series HPLC,
the Agilent 6890 GC, the Agilent
35900E A/D and the Waters
Alliance 2690 LC with a Waters
2487 Dual Wavelength Detector.
Agilent instruments implement
Level 4 instrument control using
standard LAN communications
(TCP/IP). Cerity NDS controls
instrument parameters and
components and collects digital
signals from detectors. Data can
be acquired at rates up to 200Hz,
the data rate required for fast
GC and supported on the Agilent
gas chromatographs.
3
Before the instruments can be
used, they must be configured to
an acquisition controller. One
enabling Agilent instrument
control license is required for
each instrument. Instrument
control licenses are available for
the Agilent 1100 Series as
Agilent product number G4061AA,
the Agilent 6890/6850 GC as
Agilent product number G4063AA
and the Agilent 35900E Dual
Channel Interface as Agilent
product number G4064AA.
Waters Alliance Instrument Driver
Cerity NDS provides full
instrument control of and data
acquisition from the Waters
Alliance LC system. Instrument
control of and data acquisition
from the Waters Alliance LC
require a direct connection
between the computer and
instrument, using an Agilent
82350 PCI high-performance
GPIB interface adapter and
cable. The standard interface
control library software (SICL)
required for GPIB communication
is delivered with the Cerity NDS
software. It must be installed on
the acquisition controllers where
the GPIB support is required.
(GUI) of the review client.
Sample and sequence scheduling,
instrument status monitoring,
method setup, results review and
approval and other tasks can be
performed from the Cerity NDS
review client.
modules, instruments, logon
permissions, user capabilities
and roles, auditing and system
wide settings.
available for Cerity NDS for
Pharmaceutical QA/QC reads
required details from the system
directly and inserts them into
the document automatically. The
utility provides input forms for
details that cannot be extracted
automatically from the system
(software and hardware). The
entry forms support further
techniques for automated data
entry such as bar coding.
A separate instrument control
license (Agilent product number
G4062AA) is required for each
Waters Alliance HPLC system
controlled by Cerity NDS for
Pharmaceutical QA/QC.
Data processing and review
The Cerity NDS review client is
the interface to the Cerity NDS
system. Users perform their work
with the graphical user interface
Software Administration Console
The presentation of the GUI in the
Cerity Software Administration
module is made possible by
integrating the Cerity Software
Administration module with the
Microsoft Management Console
(MMC) and its user interface.
MMC is a console designed to
integrate management tools
and functions and to present a
common visual environment for
management applications. Only
NT administrators can log on to
the console. The Cerity Software
Administration module permits
administrators to set up system
components, administer and
track software licenses and
license consumption, application
4
Installation Qualification Tool (IQT)
The Installation Qualification
Tool is a computer-based
qualification utility used to
perform Installation Qualification
(IQ) of the Cerity NDS for
Pharmaceutical QA/QC system.
Computer-based installation
qualification protocols verify the
completeness and intactness of
the Agilent software installed on
the PC. The computer-based
installation qualification utility
Execution of the software IQ
protocol requires a valid IQ
license. Without a valid license
number, the final acceptance
protocol cannot be generated.
Operation Qualification Tool (OQT)
OQ allows qualification tests at
defined intervals on the data
system and the connected
instruments. Without a valid
OQ/PV test result, the system
must not be used. OQ/PV typically
requires a series of different tests
depending on the instrument,
the lab’s specification and the
configured software capabilities.
System IQ and OQ/PV are provided
both as a product and as a service
from Agilent Technologies. The
scope of the validation services
and products for Cerity NDS
includes the Agilent 1100 Series
HPLC, Agilent 6890 GC, Agilent
35900E A/D and software system
qualification.
The Operational Qualification
Tool is a computer-based
qualification utility used to
perform Operational Qualification
(OQ/PV) of the Cerity NDS for
Pharmaceutical QA/QC system.
The computer-based OQ protocols
available for Cerity NDS for
Pharmaceutical QA/QC uses well
defined interfaces (so-called test
harnesses) specifically designed
into the software for the purpose
of executing critical system test
cases automatically. This comprises
• A number of test cases require
scripted manual tests because
of their interactive nature. The
test scripts cover areas such as
challenging logon security,
auditing of interactive changes,
authority checks, and
archive/restore functions.
• Automatic low and mid-level
functional tests that verify
fundamental system-level
functions that are not even covered by the traditional interactive protocols available for
other data systems
• Automatic high-level system
operation tests that verify
application functionality such
as sequencing, quantification or
recalibration. These tests execute in unattended mode and
the evaluation is performed
automatically using known data
source, prerecorded acceptance
limits and selfevaluating reports.
Execution of the OQ protocols
requires a valid OQ license.
Without a valid license number,
the final acceptance protocol
cannot be generated.
Cerity NDS for Pharmaceutical QA/QC
Professional
Table 1 lists the minimum
computer configuration that is
supported for a Cerity NDS for
Pharmaceutical QA/QC professional
system. This next table provides a
guideline for computer hardware
specifications, such as the
amount of random access memory (RAM), disk space measured in
gigabytes (GB), central processing
unit (CPU) speed measured in
megahertz (MHz), etc.
Hardware Requirements
The data system consists of a
personal computer (PC) and
Agilent software. All hardware
and peripherals must appear in
the appropriate Microsoft
Windows Compatibility Lists for
the operating system. Cerity NDS
for Pharmaceutical QA/QC is
designed to run on computers
that conform to the specifications
listed below.
Specification
CPU
Memory
Disk
Display
Low end
High end
4 single channel instruments
Pentium III
512 MB, 1GB virtual memory
20 GB
1024 x 768 pixels, 65536 Colors
8 single channel instruments
Pentium III
1 GB, 1GB virtual memory
40 GB
1024 x 768 pixels, 65536 Colors
Table 1
Recommended hardware configuration Cerity NDS Professional
5
Cerity NDS for Pharmaceutical
QA/QC Client/Server
Database Server Configurations
Overview
Table 2 specifies the minimum
and recommended hardware
configurations for a database
server.
NOTE:
• It is NOT recommended to use
the Cerity database server as a
print server for the Review
Client computers.
• It is not recommended to use
the Cerity Database server
for network administration
services such as domain
control (Primary Domain
Controller PDC or Backup
Domain Controller BDC).
• RAID 1 is recommended for
the operating system, Oracle
(application and data) and
Cerity application disks.
• RAID 5 is recommended for
the BLOB disks;
• RAID 0 is recommended for
the backup disks
• Consider additional disks and
disk array storage for better
performance and reliability.
One or more Rack-Storage/12
arrays configured with
18Gbyte or 36Gbyte drives
allow for larger database sizes
and better performance by
multiple RAID arrays for
the different database I/O
subroutines.
Acquisition controller
Client/Server configurations allow
the addition of optional acquisition
controllers to balance instrument
data stream and buffer it before
upload to the central database
server. The Cerity NDS acquisition
Medium
High end
Specification ≤ 20 instrument channels
≤ 10 concurrent users
Entry Level
≤ 70 instrument channels
≤20 concurrent users
> 70 instrument channels
> 20 concurrent users
CPU
Pentium III, 1 GHz
Pentium III, 1 GHz
Dual processor
recommended for
>50 instruments
Pentium III, 2x 1 GHz
(dual processor mandatory)
Memory
512 MB minimum,
1GB recommended
1GB minimum,
1.5 GB recommended
2048 MB
Disk Space
8 GB: Operating System,
Oracle and Cerity application
18 GB: Oracle Tablespace
(RAID1)
21 GB (RAID5): BLOBs1
(compressed)
8 GB: Operating System,
Oracle and Cerity application
52 GB (e.g. 18+35 GB
in RAID1 configuration):
Oracle Tablespace
70 GB (RAID5):
BLOBs (compressed)
8 GB: Operating System,
Oracle and Cerity application
70 GB (e.g. 3 RAID1
subsystems of 18, 18, 35GB):
Oracle Tablespace
150 GB (RAID5):
BLOBs (compressed)
21 GB (RAID0): Temporary
space for backup utility
(compressed)
70 GB (RAID0): Temporary
space for backup utility
(compressed)
150 GB (RAID0): Temporary
space for backup utility
(compressed)
1024 x 768 pixels,
65536 Colors
1024 x 768 pixels,
65536 Colors
1024 x 768 pixels,
65536 Colors
Display
Table 2
Minimum and recommended hardware configurations for Cerity NDS database server
controller is a dedicated Windows
NT Workstation running the Cerity
NDS acquisition controller software.
• For configurations with more
than eight instrument channels,
it is recommended to install
acquisition controllers separately from the database server.
• For typical system configurations
with 150 channels or less, it
is recommended to use one
acquisition controllers for
every 15 instrument channels.
• There is no hard-coded limit on
the number of instrument
channels that can be collected
by a single acquisition controller.
The recommended maximum
number of chromatography
signal channels for an
acquisition controller is 15.
1
6
BLOB: Binary Large Object
• Acquisition controllers can
also be used to balance the
reprocessing load within a
distributed Cerity NDS
installation. In this case, the
acquisition controller serves
as a dedicated reprocessing
server.
1. Plan your client/server systems
to that you use no more than 15
channels for each acquisition controller. For example, a 35900E
with 2 channels configured and a
DAD with all 5 signals configured
leaves 8 available channels.
2. For large systems with a heavy
processing load, add an additional
acquisition controller for every 10
review clients in your client/server
system to perform off-line
reprocessing. Do not add any
instruments to these systems.
Table 3 specifies the minimum
hardware requirements for an
acquisition controller.
CPU
Memory
Disk
Display
If server computers are available
for acquisition controllers, RAID
controllers are recommended.
Fast PCs with sufficient RAM are
also acceptable. For system
redundancy, please consider
standby computers to be used in
case of computer hardware failures.
Table 3
Hardware prerequisites for Cerity NDS acquisition controller
Review client
Review clients are workstations
used for interactive entry of sample
and sequence data, method entry
and management, scheduling of
analyses, data review, reporting
and result approval.
CPU
Memory
Disk
Display
Pentium III
256 MB (8 instruments), 512 MB (15 instruments)
20 GB
1024 x 768, 65536 Colors
Pentium III
Minimum 128 MB, 256 MB recommended
8 GB
1024 x 768, 65536 Colors
Table 4
Hardware prerequisites for Cerity NDS review client
Table 4 specifies the minimum
hardware requirements for
review a client. Keep in mind, as
previously stated, the acquisition
controller and review client may
operate together on a computer.
It is recommended to deploy
dedicated acquisition controllers
for optimum performance and
load balancing in the Cerity NDS
cluster.
Operating System/Software Requirements1
• Microsoft Internet Explorer
revision 5.5 or greater
(included with product)
• Microsoft Data Objects
Components “MDAC”, revision
2.5 or greater (included with
product)
• Oracle Standard Edition, rev.
8.1.7.2.1 (media and 5 licenses
included with the base products,
G4000AA and G4001AA)
Table 5 defines the operating
system requirements for each of
the Cerity NDS for pharmaceutical
QA/QC components.
A.01.01
A.01.02
A.01.03
Cerity NDS for Pharmaceutical
QA/QC Database Server
NT 4.0 Server SP6a, Windows 2000
N/A
Hotfix Q316211
Advanced Server2 SP2
Cerity NDS for Pharmaceutical
QA/QC Acquisition Controllers
and Review Clients
NT 4.0 Workstation
SP6a, Hotfix
Q316211
Cerity NDS for Pharmaceutical
QA/QC Professional
NT 4.0 Workstation Windows 2000
SP6a, Hotfix Q316211 Professional SP2
Windows 2000
Professional SP2
Review Clients only:
Windows 2000
Professional
SP2 Terminal Server
N/A
Table 5
Operating System Requirements
Note: Cerity for Pharmaceutical QA/QC is only supported in either a pure NT4 environment
(A.01.01) or a pure Windows 2000 environment (A.01.02 or greater). Agilent will issue service
packs for either version if necessary.
1 Cerity NDS for Pharmaceutical QA/QC is fully tested and supported on the US-English version of
NT and Windows 2000. It is highly recommended to use US English as input locale. Please consult
the software status bulletin and release notes for more information on regional settings, number
and date formats. Localized versions of the operating system are supported on a best effort basis
and require the corresponding local-language hotfix to be installed. The hotfix is supplied on the
Cerity NDS CD media in the following language versions: English, German, French, Spanish, Italian,
Japanese.
2
If applicable, required operating system hotfixes are included on the product media.
7
Table 6 defines the third party
required software revisions
to properly operate Cerity NDS
for pharmaceutical QA/QC
client/server and professional
systems. Any of these components
is installed automatically during
Cerity setup, except for the
Oracle Database Management
System (DBMS) which needs
to be installed separately.
Oracle Licensing
Cerity NDS for Pharmaceutical
QA/QC uses the Oracle RDBMS
to manage and store its records.
• The Oracle RDBMS software
may only be installed and used
if the appropriate software
licenses have been purchased.
You must possess an Oracle
license for each user account
(“named user”) established in
your Agilent Networked Data
System valid for use with the
Agilent NDS software.
• The base products of Cerity
NDS for Pharmaceutical
QA/QC (Agilent G4000AA and
G4001AA) include 5 application
specific named user Oracle
client licenses. These licenses
are subject to a restricted use
license and can only be used
in conjunction with the NDS
application.
• Agilent provides support for
included Oracle software
according to the application
requirements of the respective
Agilent networked data system.
Further software maintenance
for Oracle software must be
purchased separately
• Alternatively, you may purchase
full use Oracle licenses from
Oracle Co. or their authorized
distribution partners.
8
Manufacturer
Product
Revision
Comment
Oracle
Oracle DBMS
8.1.7.2.1
Shipped on product CD-ROM; needs to
be installed separately. Oracle Standard
8.1.7 is contained on Cerity product CD #2.
Oracle Update 8.1.7.2.1 is mandatory and
included with the Cerity product CD #3.
Microsoft
Internet Explorer
5.5
Needs to be installed separately.
Included on Cerity CD#1.
Microsoft
Visual Basic
6.0 SP4
Runtime library
Runtime library
Microsoft
Visual C++
6.0 SP4
Inprise (Borland)
C++ Builder
5
Runtime library
Agilent
SICL library
J.02.00
is needed for GP-IB connection
to Waters Alliance
Table 6
Other software requirements for Cerity for Pharmaceutical QA/QC
• Each individual with a logon to
the Cerity software requires a
separate Oracle client license.
• Additional Oracle licenses,
can be purchased using Agilent
product number G1411A.
Please note that Oracle
licenses delivered by Agilent
Technologies are applicationspecific and may only be used
within the context of the
Agilent networked data system.
Cerity NDS for Pharmaceutical
QA/QC License
The number of Cerity NDS
concurrent licenses in use must
not exceed the number of licenses
installed, otherwise the license
agreement is violated. Additional
licenses are easy to order and
easy to install. The Cerity NDS
licenses float and are consumed
by concurrent users. For the
client/server configuration,
there must be an equal number
of Cerity NDS licenses as there
are Cerity NDS concurrent users.
Cerity NDS for Pharmaceutical
QA/QC Professional (Agilent part
number G4000AA) is a single-
user system and includes one
concurrent Cerity user license.
The following restrictions apply:
• Only one Cerity user can be
logged on to the computer at
any given time.
• Part number G4002AA (add
concurrent Cerity NDS user),
is not applicable to the
professional system. If the
professional system is used by
different operators at different
times, each individual user
requires a separate named
user license of Oracle Standard
valid for the Agilent NDS family
of products.
GMP Module License
• One GMP license is needed for
each concurrent user license
(Agilent part number G4002AA)
• The GMP module enables strict
auditing, audit comments and
e-signature.
• The GMP module also enforces
a strict results review/approval
process. This will ensure that
analysts review their own
results before a peer reviewer
and finally, a final approval is
given.
This is an enabling license; no
additional software is installed.
The GMP module enables the
audit node in the Cerity System
Administration Console.
Note: Only one GMP license
is needed in the professional
system.
Instrument Control License
One instrument control license is
required per instrument controlled
by the Cerity NDS software. The
licenses are easy to install,
and they are monitored by the
application.
Cerity instrument control licenses are available for the following
products:
• Agilent part number G4061AA
for instrument control and
data acquisition of the Agilent
1100 Series HPLC
• Agilent part number G4062AA
for instrument control and
data acquisition of the Waters
Alliance LC
• Agilent part number G4063AA
for instrument control and
data acquisition of the Agilent
6890/6850 GC
• Agilent part number G4064AA
for instrument control and
data acquisition of the Agilent
35900E Dual Channel Interface
Supported Analytical Instrumentation
Agilent 1100 Series
Liquid Chromatograph
Full (Level 4) instrument control
of the Agilent 1100 Liquid
Chromatograph via LAN interface.
In revision A.01.0x, the following
modules are supported:
• Agilent 1100 isocratic, binary
and quaternary pumps
• Agilent 1100 VWD, MWD and
DAD (in 2D-chromatography
mode)
• Agilent 1100 standard and
thermostatted autosampler
• Agilent 1100 thermosttated
column compartment
• Agilent 1100 vacuum degasser
NOTE: 3D-spectral data
acquisition and evaluation
from the Agilent 1100 Series
DAD and FLD are scheduled
for revision A.02.01.
Agilent P/N
Agilent 1100 Series Module Description
Minimum
Firmware
G1310A
G1311A
G1312A
G1313A
G1329A
G1330A
G1314A
G1315A
Isocratic pump
Quaternary pump
Binary Pump
Autosampler
Thermostated Autosampler
Autosampler Cooling module
Variable Wavelength Detector (VWD)
Diode Array Detector (DAD)
A.05.01
A.05.01
A.05.01
A.05.01
A.05.01
N/A
A.05.01
A.05.01
G1315B
G1316A
G1322A
G1323B
G1365A
G1365B
Diode Array Detector (DAD)
Thermostated Column Compartment (TCC)
Online Degasser
Control module
Multiple wavelength detector (MWD)
Multiple wavelength detector (MWD)
A.05.01
A.05.01
N/A
B.01.02
A.05.01
A.05.01
Comment
Requires mainboard rev. B
No spectra acquisition, up
to 5 simultaneous signals;
Requires mainboard rev. B
Table 7
Supported Agilent 1100 Series LC modules
One Agilent 1100 Series LC
instrument control license is
required per Agilent 1100 Series
LC system connected to the Cerity
software.
A LAN interface is required for
the Agilent 1100 system. The
GPIB interface is not supported
in Cerity NDS for Pharmaceutical
QA/QC for this instrument.
9
Agilent 35900E Dual Channel Interface
This interface can be used to
acquire up to two independent
channels of data from instrumentation that is not directly
controlled by the software.
The Dual Channel Interface
supports data rates up to 100 Hz.
The Agilent 35900E Dual Channel
Interface supports BCD-coded
vial number and can be used to
track the vial position of each
injection from third party auto
samplers in the software. One
Agilent 35900E A/D instrument
control license is required per
Agilent 35900E dual channel
interface connected to the Cerity
software. For firmware requirements, refer to table 8.
A LAN interface is required for
the dual channel interface. The
GPIB interface is not supported
in Cerity NDS for Pharmaceutical
QA/QC for this device.
Agilent 6890 Gas Chromatograph
Cerity NDS for Pharmaceutical
QA/QC revision A.01.0x will
support the Agilent 6890A,
and 6890N (table 10).
A LAN interface is required for the
Agilent GC. The GPIB interface is
not supported in Cerity NDS for
Pharmaceutical QA/QC for this
instrument.
Waters Alliance
Full control of the solvent delivery
system, column heater and
autosampler of the Waters 2690
Alliance Liquid Chromatograph
via GPIB interface (optionally
available with the software).
Up to four Waters Alliance
chromatographs can be controlled
through a single GPIB interface.
10
Agilent P/N
Description
Minimum Firmware
Comment
35900E
A/D converter
E.01.02
Data acquisition,
remote start/stop, BCD
G1530A
6890A GC
A.03.05
G1530N
6890N GC
N.04.08
LAN Board FW 04.5BD
G2612A (Controller) 7683 Autosampler
G2613A (Injector)
A.01.07
A.10.04
G2614A (Tray)
A.01.02
Via 6980 only
Full control,
dual simultaneous
injection not supported
G1512A (Controller) 7673 Autosampler
G1513A (Injector)
A.01.12
A.09.14
18596C (Tray)
N/A
7694E
Headspace
Via 6980 only
Full control,
dual simultaneous
injection not supported
1.02B
Via 6980 only in
standalone mode
Table 8
Firmware revisions of other instruments supported by the software
Model Number
Description
Firmware
Comment
Waters 2690
Waters Alliance
1.21
The Waters 2690 has also been
tested successfully using rev. 2.0
of the 2695 firmware
Waters 2487
Waters Dual
1.01
Wavelength Detector
Table 9
Supported Waters instrumentation
Agilent 6890A GC
Inlet:
Column Inlet:
Column Outlet:
Oven:
Detector:
EPC—S/S, EPC—P/P, EPC—COC
Front, Back, Unspecified
Front, Back, Other, MSD, AED
High Ramp Rate
AIB, EPC—FID, EPC-FPD, EPC-NPD, EPC—TCD, EPC—ECD, EPC—uECD
Cryo:
Valves:
Aux:
CO2, N2
GSV, LSV, Multiposition, Switching,
EPC, Temperature
Data Channels:
In revision A.01.0x, dual simultaneous (“dual tower”) injection is not supported
Table 10
Supported Agilent 6890 GC configurations
Full control of the Waters 2487
Dual Wavelength Detector via
GPIB interface. For firmware
requirements, refer to table 9.
One instrument control license
is required per Waters Alliance
system (consisting of one Waters
2690 Alliance mainframe and one
Waters 2487 detector)
connected to the Cerity software.
A remote start-stop cable is
required to synchronize the
Waters detector with the LC.
Network Infrastructure
Overview
The Cerity NDS infrastructure
adheres to operating system and
common IT standards. TCP/IP is
the communication mechanism
used by the Cerity NDS system.
This system includes Windows NT,
Cerity NDS software, network
printers, instruments and other
networked devices.
TCP/IP protocol accomplishes
communication among network
nodes, which includes analytical
instruments, computers, network
devices, etc. This is the primary
protocol for communication
among components in the Cerity
NDS cluster. It is required on all
Cerity NDS computers. Cerity
NDS for Pharmaceutical QA/QC
uses TCP/IP as delivered with the
operating system.
Some advantages and benefits to
the client/server model:
• Emphasis on user-friendly
applications and consistent
interface
• Applications are distributed
• Data is centralized
• Facilitates open and modular
systems
• Networking is fundamental to
the process
• Distributed system provides
redundancy and robustness
• Distributed processing provides
power without monopolization
of resources
• Seamless growth and scalability
of configuration
• Industry standard network
device compatible
• As many users as resources permit can be configured in the
Cerity NDS cluster
• Concurrent Cerity NDS user
licensing
• The Oracle licenses apply to all
enabled, configured, Cerity users
• Multiple database servers may
exist in a domain
• Multiple database server
connectivity by review clients
• Multiple review client support
• Multiple acquisition controller
support per database server
• Multiple instrument support
per acquisition controller
• Multiple network printer
support
• Microsoft domain security
• Cerity NDS cluster security
• Centralized system
administration
• Centralized backups
• Supported import and export of
data between database servers
• Enterprise connectivity
• Dedicated hardware resources
Network interfaces
To connect Agilent Technologies
instruments to an Agilent
Technologies Cerity NDS for
Pharmaceutical QA/QC system,
an HP JetDirect Connectivity Card
is required. Table 11 lists all
HP JetDirect Connectivity Cards
supported with the Cerity NDS for
Pharmaceutical QA/QC software.
Agilent P/N LC
Agilent P/N GC
Assignment of IP addresses
• The system requires a static IP
address for the database server
module, which is installed by
selecting the Cerity Professional
or Cerity Database Server
installation.
• IP addresses for clients,
acquisition controllers and
instruments may be allocated
statically by using the Bootstrap
Protocol BOOTP, or dynamically
using the Dynamic Host
Configuration Protocol DHCP.
• The Cerity NDS system
includes a dedicated BOOTP
server which operates as a
service in NT. The Agilent
BOOTP service should be
used if no other BOOTP server
or DHCP server are available
to assign IP addresses to
networked instrumentation
and clients.
• The instrument configuration
requires specific buffer settings
on the Jetdirect interface card.
These buffer settings are
automatically configured by
the Cerity Software
• If fixed IP addresses are
available and assignment via
BOOTP or DHCP from a
server is not required, the
Agilent 1100 HPLC and the
Agilent 6890 GC allow setting
instrument IP addresses from
the handheld controller or
local keyboard.
Description
Minimum FW
N/A
N/A
HP J2552B MIO card for 10Base-T, 10Base2
A.08.32
G1846A
G1847A
HP JetDirect 400N (MIO) card for 10Base-T,
10Base2, 100Base-TX
K.08.32
Table 11
HP JetDirect Connectivity Cards supported with Cerity NDS for Pharmaceutical QA/QC software
11
Functional Specifications
Technology and Architecture
General description
Cerity Cerity NDS for Pharmaceutical QA/QC is a fully scaleable
networked data system for analytical QA/QC laboratories that require
chromatographic instrument control, data acquisition, data analysis,
flexible reporting and with strict adherence 21 CFR Part 11 (electronic
records and electronic signatures) and related predicate rules such
as to 21 CFR 210 (GMP) and 21 CFR Part 211 (cGMP).
Description
of data repository
Central, secure data repository based on Oracle database
management system.
Supported Database
Management System
Oracle 8i (Oracle® 8.1.7.2.1)
Data Model
Object-relational data model.
Maximum size
of data base supported
No hard-coded limits.
Design language/tools
UML, Visual C++, Visual Basic
Operating System
A.01.01 Windows NT 4.0 SP 6a
A.01.02 Windows 2000 SP2, A.01.03 Windows 2000 Terminal Server
Compatibility with
Windows Terminal Server.
Operation in a Windows Terminal Server environment with Citrix
Metaframe Software is currently being qualified.
Other client/server capabilities • During running analyses, users can log out and log in without
interruption of the sequence.
• After log-out of the session, the user's license is released
and available for another concurrent user.
Hardware requirements
See separate chapter in this document
Scalability
Cerity NDS for Pharmaceutical One user at any one time.
QA/QC Professional:
Maximum number
of concurrent users
Note: By definition, Cerity NDS for Pharmaceutical QA/QC
Professional is a single-user, multi-instrument configuration.
Cerity NDS for Pharmaceutical No hard-coded limits (function of database server configuration and
QA/QC Client/server :
available network bandwidth);
Maximum number
of concurrent users
Typical configurations have 30-50 users and 80-100 instruments.
User Interface
Characteristics
of the User Interface
Graphical user interface designed in adherence to Windows
standards and configurable to laboratory specific workflow (based on
user roles and analysis specific requirements).
The user interface of Cerity NDS for Pharmaceutical QA/QC is
streamlined to adhere to the requirements of GMP regulated QA/QC
labs.
This includes, but is not limited to
• Convenient arrangement of functions into four context areas: Sample
Entry, Instrument Status, Results Review and Method Management
• Graphical Instrument Status Display
• “Explorer”-like Tree-View to conveniently display search results
from the database
• Menus (pull-Down as well as context menus)
• Toolbars
• Tables configurable to the method
User specific storage of
user interface configuration
details (profiles)
12
Specific to job roles and analytical methods.
If a user has no permission to use a certain system function, the
function is not shown in the user interface or it is disabled (grayed out).
Analytical instruments
Supported analytical techniques LC, GC, A/D converter (general purpose)
Number of instruments that
system can simultaneously
control and acquire data from.
No hard-coded limits (function of database server configuration and
available network bandwidth);
Typical configurations have 30-50 users and 80-100 instruments.
Data acquisition interfaces
LAN
Level 4 instrument control of Agilent 1100 LC, 6890 GC and 35900E
ADC, using TCP/IP protocol as installed with Microsoft Windows NT.
IEEE-488 (HP-IB/GP-IB)
Based on standard interface control library (SICL)
Level of bi-directional
instrument control
Level 4 instrument control for instruments with appropriate
capabilities (e.g. Agilent 1100 and Agilent 6890)
Level 3 instrument control for Waters Alliance LC and the Waters 2487
Dual Wavelength Detector..
Instruments for which
bi-directional control
is supported.
Agilent 1100 Series LC, Agilent 6890 GC, Waters Alliance,
Agilent 35900E ADC for general purpose/multi-vendor interfacing
Proprietary control hardware
required?
No. Instruments interfaced via LAN require a HP JetDirect LAN
interface and an Ethernet LAN card in the PC. Waters Alliance
instruments are interfaced via GPIB (IEEE-488) and require an
Agilent 82350 GPIB board in the PC
Data Transfer
Data import formats
• Data files from Agilent ChemStation A.03.01 or greater
• ANDI (Analytical Data Interchange) format
• Import of work-lists in XML format, e.g. from a LIMS.
Data export formats
• Microsoft Excel format (XLS) for tabular data
• HTML for analytical reports
• JPEG, GIF, TIFF, WMF for graphics
• ANDI (Analytical Data Interchange) format
Standard interface protocols
supported between network
components of the system
COM+/DCOM
Results review
(o-line on-demand viewing)
By design, all result records are available for instantaneous online
review in the results review context of the application.
Direct FAX or PDF output
Through standard operating system functions
(print to fax, print to PDF device)
Other interfaces
Examples for further customization based on the following techniques
• Reports post-processing through DOM (Document Object Model)
• Reports post-processing through embedded scripts (Javascript or
VBScript code)
• Web-Access to queries through SSL (Secure Sockets Layer)
Documentation
Description of documentation • How-To Tasks (Online Help),
delivered with the Cerity system • Cerity Quick Reference Card
• Cerity Concepts Guide
• Getting Started Cards
• Cerity Installation Guide
• System Administration Guide (Online, PDF)
• Cerity Technical Reference Guide
• GC Operation in Cerity for Pharmaceutical QA/QC
Description of formats
PDF and HTML Help
used for online documentation.
Number of printed manual
sets provided with system
One set per user license
(Note: Additionally, PDF-versions of all manuals are included on the
software media)
Link to standard operating
procedures SOPs
The application user interface allows to configure a link directly to
the intranet location where SOPs or monograph are stored
13
Access security and control
Security concept
Based on NT security system
(user accounts management, password policy).
Application does not have a proprietary account system but allows
reusing password and security policies directly from the operating
system.
Access controls
for security configuration
User with Cerity system administrator permissions.
Note: Cerity system administrators require system administration
permissions on the local computer
Granularity of security access
Managed at the individual function level of the application.
Menus and toolbar functions can be selectively configured for
each user role. Examples: Create method, reprocess chromatogram,
approve result etc.
Description of
application security controls
• Cerity users must be authenticated through the operating system
• Mandatory login using user-ID and password
• Cerity uses a role-based security concept based on job roles and
job responsibilities of users.
• Prior to executing a function in the system, Cerity's security
service checks whether the user has the appropriate capabilities
• Mandatory audit trail every time a record is created, modified or
destroyed
• Cerity allows to configure which system tasks require authorization
by electronic signature (e.g. accept/reject an analysis result).
• System-wide inactivity time-out locks the session after
a predefined idle period
• Physical access security controls are not enforced by the application,
but the system is compatible with physical access security controls
such as bio-metric or smart-card identification as supported by the
operating system.
Security mechanism
of network data packets
Yes, using COM+ security
Encryption key length
Depends on local OS version (128 bit in US version)
Biometrics-based identification Planned for subsequent release:
Support biometrics-based identification with standard interfaces for
face recognition, voice recognition, fingerprint scanning
Instrument Status and Analysis Scheduling
Instrument Status Monitoring
Figure 3
Transparent access
to connected instruments
14
• Transparent real time access to any instrument connected to the
network, independent of the instrument and the client computer.
• Transparent access to instrument control and equilibration functions
such as reset injector, lamp on/off, balance detector, wavelength
calibration
Real-time display
Configurable online plot for detector channels and diagnostic plots
(e.g. thermostat temperature, pressure, flow)
Instrument actuals
Configurable status information table (run-time, instrument errors,
warnings, diagnosis buffers)
Real-time status – finding out
why the instrument is in an
error state or not ready.
Cerity offers three troubleshooting mechanisms for problems such as:
• instrument status GUI and instrument actuals
• instrument logbook
• “Service Report” function that queries the diagnostic registers of
the Agilent 1100 Series to generate a service report that helps to
diagnose instrument problems down to the module level
Scheduling of analyses
(“chaining of analyses”)
The system uses a scheduling process that allows submitting analysis
jobs (single sample analyses as well as sequences) to the so-called
worklist.
The analysis priority is entered at sample entry and can be high,
medium or low.
Sample/sequence entry
Automatic data entry
A so-called “Sequence Template” can be configured as part of the
Cerity method.
When creating a new sequence, the new sequence is pre-filled
based on the settings defined in the sequence template stored in
the analysis method.
Mechanisms to minimize
typing effort during data entry
• Fill-down column
• Intelligent fill-down wizard
• Apply changes to a selection of sequence lines
Revision control of sample data Sample data is subject to strict revision control within the application.
Entry of calibration standards
Weights (concentrations) of calibration standards can be directly
entered during sample entry.
Partial calibration and multi-vial standards are supported (standard
compounds of a certain level can be provided in different vials)
Method specific sample
variables
Method specific sample variables (multipliers, divisors) are entered
during sample entry and available for custom calculations.
Custom naming of method
specific sample variables
Yes, names are configurable per method
Naming conventions
allow for long descriptors
Names and description fields for samples, sequences, methods and
instruments permit long descriptive names with at least 128 characters.
Operator can selectively
run data acquisition,
processing, reporting
When scheduling an analysis, operators can selectively define
which processing tasks will be performed. Options include data
acqusition, data analysis and reporting.
Method Management
Change control to methods
Cerity subjects all methods to strict revision control and audit trail
maintained in the data system logging. No part of the method can be overwritten.
Who needs to modify methods Method management is typically only required for a senior chemist
or chemist.
Analysts (chemists, technicians) typically work with predefined
methods.
Master methods
(template methods)
Master methods are protected methods that serve as template for
instrument specific methods. By using a master method, analysts
can be sure that the analysis settings are coherent with the official
analysis procedure.
Linking methods
to analysis procedures
Cerity allows translating a chromatographic analysis procedure into
a Cerity method. This includes the required sample entry variables,
calculations, recalibration schemes, layout and reporting requirements
and templates for the sequence of injections
15
System checks to ensure
consistency between method
parameters and physical
instrument capabilities
The software queries the current configuration details from the
physical instrument prior to starting the analysis to ensure that the
analysis parameters are compatible.
Cerity methods are specific to an instrument configuration
(e.g. Agilent 1100 Series LC with a DAD and a binary pump) and can
be applied for groups of instruments that have the same configuration.
Typical interaction of an
analyst with a method
• Login to system
• Select sample entry context (view)
• Login the sample
• Select the method (the system automatically suggests
the instrument suitable for this analysis)
• Enter sample information (description, name, vial number, product
code, LIMS ID, concentration of standard etc.)
• Schedule analysis
Settings controlled
by the Cerity method
• Sample variables (multipliers and divisors)
• Limits
• Example chromatogram (i.e. a typical chromatogram as generated
with this analysis) for display in online results review and on reports
• Instrument control/data acquisition
• Integration
• Peak identification
• Calibration
• Quantification
• Custom calculations
• Reporting
• Data review layout
• Reporting
Reintegration
• System allows reintegrating results in the controlled environment
of Cerity results review context.
• Fine-tuning of integration settings on a specific chromatogram is
performed under strict revision control of the result record
• Fine-tuning of integration settings on a specific chromatogram
remain private to the chromatogram and do not implicitly affect the
master method
Reprocessing
• Reprocessing functions allow to reprocess data with modified
parameters, or a different revision of the same method or a different
method
• Reprocessing calculations are subject to audit trail and revision
control functions of the software
Data review layout
• The method stores so-called “data review layout” settings
• Data review layout defines the content and layout of the graphical
and tabular display of results generated with a particular analysis
method
• The data review layout is used to show analysis results consistently
in the application's result review context.
• The result display is method specific and independent of the user
and the client PC used for the review.
Sequence template
• The method allows storing the so-called “sequence template”
• The sequence template defines the normal sequence of injections
required for analyses run with this method: blank injections,
system suitability, standards, samples, QC samples etc.
• The sequence template of the method minimizes data entry effort
during sequence setup
16
Data Analysis
Integration algorithm
Revised version of the Agilent Enhanced Integrator.
Integration events
The system allows setting integration events to change integration
parameters appropriate for the signal measured during the analysis.
Typical integration events include, but are not limited to:
• Area reject
• Height reject
• Slope sensitivity
• Peak width
• Shoulder detection
• Tangent skimming
• Detection of negative peaks
Standard quantification modes Area%,
Norm%,
External Standard Quantification (ESTD),
Internal Standard Quantification ( ISTD)
Description of recalibration
The system supports flexible calibration schemes:
schemes for sequence analyses • Moving average calibration (single update calibration)
• Standard bracketing
• Overall bracketing (also known as “grand average bracketing”)
Description of overall
bracketing calibration scheme
Two bracketing modes are available. Overall bracketing calculates
one calibration curve per calibrated compound for the sequence and
uses it for the quantification of all samples in the sequence. In terms
of validation and traceability, this is a lot easier to handle than other
floating average recalibration schemes.
Description how the system
prevents discrepancies between
printed reports and results
displayed on the screen.
The Cerity report writer is a rendering device that only displays data
already stored in the central data repository and does not perform
any calculations of its own. This is to avoid discrepancies between
results shown on screen and paper.
Description of how system
controls re-integration and
reprocessing in a controlled
manner according to GMP
and 21 CFR Part 11.
Every modification of a test result (e.g. in the course of reintegration
or reprocessing using updated calibration information) results in a
new revision of the result record along with tight links to the
metadata and result.
Manual intervention in the integration of a chromatogram
is notified in the report and in the system's online results view
using the following measures:
• Definition of user capabilities for authorized access
• Strict auditing with mandatory audit comments
• Authorization by electronic signature (configurable)
• Data review layout and Report templates set up to include analysis
audit trail and method version
Support of method specific
calculations
Yes, through spreadsheet integrated into the data analysis method.
Supported calculation functions Arithmetic, logical, statistical functions also available in off-the-shelf
spreadsheet programs
Storage of method specific
calculation results
Yes, including calculation formulae
Triggering of warnings
(pass/fail information) based
on calculation results
Yes, such as warnings if system suitability or other limits
are exceeded.
Description of user-defined
(custom) calculations
The built-in Custom Calculator spreadsheet. This allows setting up
method specific calculations, for individual peaks in a single injection,
groups of compounds in groups of injections and even summary
statistics for entire sequences.
17
Specialized calculation
functions
Custom calculations for single injections, groups of injections and
sequences are available in the custom calculator built into the data
analysis method.
Examples:
• Impurity calculations
• Reproducibility calculations for replicates
• Group statistics
• Response factor statistics (calibration precision)
Figure 4
Setting up a method-specific statistical group calculation in the “Custom Calculator”
Description of system
suitability criteria and limits.
• Cerity calculates peak performance parameters according to the
different pharmacopoeias (USP, EP, BP, JP and DAB). The user can
configure which of them are reported and shown.
• System suitability limits can be defined by component
and sample type.
• Available noise calculations: peak to peak and ASTM
Description of peak
identification mechanisms.
• The system supports identification by absolute and relative
retention times (RRT).
• Peak windows for peak recognition are customizable per peak
using absolute or relative peak retention time windows
• Peak summing and peak grouping
• The system compensates for retention time variability during
analyses using reference peaks for the RT update
• Peak naming is flexible and allows for long names
• Peak confirmation based on spectral data is planned
for subsequent release.
Calibration capabilities
The system allows multilevel calibration with an unlimited number
of levels, fixed amount, variable amount and manual response factors
Reprocessing capabilities
All chromatographic runs in a sequence can be reprocessed
automatically (“batch-wise”)
18
Available calibration schemes
Cerity supports the following calibration curves types: piecewise,
linear, quadratic, cubic, exponential, logarithmic, power, average slope.
The following weightings are supported:
• Equal
• # of calibrations
• Linear (x)
– by the factor 1/Amount
• Quadratic (x) – by the factor 1/Amount^2
• Linear (y)
– by the factor 1/Response
• Quadratic (y) – by the factor 1/Response^2
• Lg (x)
– by the factor 1/lg(Amount)
• Lg (y)
– by the factor 1/lg(Response)
• Ln(x)
– by the factor 1/ln(Amount)
• Ln (y)
– by the factor 1/ln(Response)
Calibration curve
origin treatment
• Include
• Force
• Ignore
• Piecewise (connect)
Calibration review capabilities
• An authorized user can reject individual calibration points manually
from a calibration curve; This action is subject to audit trail and
requires authorization by electronic signature if configured so.
• Calibration data display includes regression curve, correlation
coefficients, confidence intervals (configurable) and relative residuals.
Quantification capabilities
• Response factors are calculated from the calibration result and
stored automatically.
• Response factors can also be entered manually per peak.
• Response factors can be updated automatically after performing
a re-calibration
• Results can be calculated using a factor per peak in its calculations.
• Results can be calculated using the same factor for all unknown
impurities in its calculations.
• Specified impurities can be calculated using a specific factor
The systems allows to define
and check limits on system
suitability parameters.
• Cerity allows setting limits on all calculated values
(including custom calculations).
• Limits can be based on sample type
• Allows defining peak specific limits
• If a parameter is out of limit a user-defined action is performed
(e.g. trigger configurable warning )
Online Results Review and Approval
Display of analysis results
• Online results review is a separate context (view) of the application.
• Results can be queried from the Cerity database using standard or
customize queries (database searches)
• Results are displayed according to the settings defined in the data
review layout of the method
Results approval
• The system supports a 3-step results approval process
(analyst review, peer review, manager approval)
• Data can be approved, rejected, or marked for rework.
• Operational system checks ensure the approval steps are
performed in permitted sequence of steps.
Figure 5
Result approval in the
Accept/Reject screen
for results sign-off
19
Description of retrieval
capabilities
• Database queries can be defined with a query wizard
to search for data.
• Queries can be defined based on Samples, Methods, Instruments
and results.
• All results can be stored and retrieved.
Protection of electronic records All binary raw data is handled by the Oracle database and Cerity
managed by the system
information manager objects and is under strict revision control of
the Cerity security service.
The actual position of analyzed
vials in auto-samplers is
stored and reported (Part 11)
Yes, for Agilent 1100 Series LC and Waters Alliance LC.
For 3rd party autosamplers, requires BCD vial number input
to the 35900E.
All components of the system
are identified in the system
(Part 11)
Automatic tracking and storage of instrument serial numbers and
firmware revisions (depends on instrument capabilities).
Reporting
Figure 6
Example Report Template
Description of Cerity
report generator
The reporting functions consist of a graphical report template editor
and a reporting tool that extracts the data to be reported from the
Cerity database. Report design is done through drag & drop editing
of the report. Report templates are stored in HTML format. Reports
can be published to a web browser and on paper.
Configurability
of the report generator
• All Cerity reports can be customized using the report template editor.
• Report template editor allows to render (visualize) all data from the
application database.
• Item selection is done using a tree view representation of the
system's “data dictionary”
20
Figure 7
Example Report Published in a Web Browser
Description of built in reports
Single injection reports, group summary, composite
(sequence summary) reports.
Reports include headers, footers, pagination, logos, result tables,
graphics and statistics
Description
of reporting capabilities
• WYSIWYG (report preview in Internet Explorer).
The report template editor is HTML based
• Full control of format attributes (layout, fonts, colors)
• Automatic pagination
• Headers and footers
• Reports can be printed in ‘Portrait’ and ‘Landscape’.
• Chromatograms can be printed separately. (full page)
• Result files can be printed separately from chromatograms.
• Chromatograms and results can be combined on the same page.
• The system can produce summary tables per analyte
• Result reports include integration codes per peak
• Peak markers are shown on the screen and in the report.
• Peak names and retention times can be added to the chromatogram.
• Date and time of printout is reported.
• Date and time of processing or reprocessing is reported
• Date and time of acquisition is reported
• The scaling of a chromatogram in a report is user definable.
Data Archiving
Description of Cerity data
archiving capabilities
• The built-in archive/restore utility can be used to exchange
electronic records (accurate and complete copies) as well as to
restore and replay data throughout the record retention period.
• Easy transfer of electronic records to other disks or media for
long-term storage and to free up database space
• Complete audit-trail of all archiving and delete operations.
• Data selection is performed using an archive query wizard.
• XML-based archive catalog allows for interface to archive
management tools
21
Description of measures
to ensure data integrity
of archived data
• In order to maintain data integrity, Cerity archives related records
in one consistent archive.
• By design, the system prevents archiving incomplete information
(e.g. an individual injection from sequence, or injection results
without audit trail or method information).
• If archived data was deleted from online storage, it needs to be
reloaded to be accessed by the system
Support of multi-tiered
archiving technology
Requires 3rd party tool e.g., active data on hard drive, older data on
slower optical magneto-optical disks, jukeboxes.
Technical Controls for Regulatory Compliance (GxP, 21 CFR Part 11)
Designed for the regulated
environment
• The product was designed to fulfill the validation requirements
of the users of this product according to current regulations
and quality standards including, but not limited to, 21 CFR 210
(Good Manufacturing Practice for Drugs ), 21 CFR 211
(current Good Manufacturing Practice for finished pharmaceuticals),
21 CFR 58 (Good Laboratory Practice), 21 CFR Part 11 (Electronic
Records and Signatures).
Validation of systems to ensure • Software Lifecycle of Life Science and Chemical Analysis (LSCA)
accuracy, reliability, consistent
business of Agilent Technologies
intended performance, and
• Division Quality System
the ability to discern invalid
• Qualification services available for Cerity as well as the connected
or altered records (11.10a)
instrumentation
Ability to create accurate
• Through the Cerity archive/restore utility included
and complete copies of records in the standard product
(11.10b)
Protection of records to enable • Strict protection and version control within the Cerity database
accurate and ready retrieval
• Data must be archived before it can be deleted from the database
throughout record retention
(system check)
period (11.10c)
• Restored data is read-only
Limit system access to
• Yes, combination of NT security policies and Cerity access rights
authorized individuals (11.10d)
Use secure, computer• Yes, every time a record is created, modified or destroyed; this
generated, time-stamped
includes maintenance activities such as archive, restore, delete
audit trails (11.10e) to document
who did what and when.
Documentation can be recorded
without electronic signatures
themselves.
The audit trail must be created • Yes, this is the standard behavior;
by the computer system
• Options for electronic sign-off on system tasks, configurable and
independently of the operators mandatory audit comments as well as system checks for electronic
(c73).
results review and approval can be enabled using the optional Cerity
GMP module (Agilent P/NG4030AA).
All changes to existing records • Yes, every time a record is created, modified or destroyed; this
need to be documented,
includes maintenance activities such as archive, restore, delete
regardless of the reason,
to maintain a complete and
accurate history, to document
individual responsibility, and
to enable detection of record
falsification (c75).
Record changes shall not
obscure previously recorded
information (11.10e)
22
• Strict revision control, no previous entry is ever overwritten
• This is also true for data restored from archives
The system must implement
• Yes, for example,
operational system checks
• approve-reject of results
to enforce permitted sequencing (analyst review, peer review, manager approval)
of steps and events (11.10f).
• archive-delete cycle (data must be archived prior to deletion)
For example, to ensure that
manufacturing production steps
and signings to indicate initiation
or completion of those steps
are not executed outside
of the predefined order (c79).
FDA’s intent is that the computer
performs operational checks.
The system must implement
device checks to determine
the validity of the source
of data input (11.10h)
• Input verification for data entry fields (empty fields are marked red
if input is required and data ranges are checked for validity)
• Input cells are locked if data entry is not permissible
• Where available, the system automatically detects and records
instrument serial numbers and firmware revisions
(e.g. Agilent 6890 GCs and Agilent 1100 Series LCs). This ensures
and documents that the correct instrument is used for the analysis
(traceability and validity check).
• For the Agilent 1100 Series LC, the system supports the use of
column identifications tags that allow to trace and record analytical
column information (e.g. batch number, number of injections,
dimensions etc.)
• The system stores the hostname of the originating client PC when
an electronic record is created or modified.
• System allows to perform system suitability tests, automatically
checks the results against the defined limits and reports the
pass/fail results
Authority checks to ensure
only authorized individuals
use the system, electronically
sign a record, alter a record.
• Yes, for every transaction, the security services determine whether
the currently logged on user has the appropriate authorization.
(11.50a) Signed electronic
• System can show the printed name of the signer, date/time (local
records shall contain
time and timezone information), and meaning of signature online
the following information:
and on any report of data/results from the system
• printed name of the signer
• Meaning of the signature is captured in the context of the function
• local (c101) date and time
currently executed (e.g. peer review/approval) or through
when the signature
a mandatory comment.
was executed
• Meaning of the signature
(such as review, approval,
responsibility or authorship).
This does not require lengthy
explanations (c105).
(11.50b) The above items are
subject to the same controls
as for electronic records and
shall be included as part of
anyhuman readable of
the electronic record.
• Signatures become part of the original record. Changes result in
new revisions of records and previous entries are never overwritten.
(11.70) Electronic signatures
must be verifiably bound
to their respective records
to ensure they cannot be
deleted, copied or transferred
to falsify a record.
• Ensured internally in the Cerity information manager objects.
• Strict revision control (no data is ever overwritten)
• Audit trail and e-sig are part of the archived/restored records
23
(11.200) Electronic signatures
not based upon biometrics
shall employ at least two
distinct identification
components such as
an identification code
and password.
When an individual executes
a series of signings during
a single, continuous period
of controlled system access,
the first signing shall be
executed using all
electronic signature
components; subsequent
signings shall be executed
using at least one electronic
signature component that is
only executable by, and
designed to be used only by,
the individual.
It is vital to have stringent
controls that prevent
impersonation: Automatic
inactivity disconnect measures
(c124).
• Login to the operating system requires entering user id
and password of the valid NT user
• Login to application requires entering NT user id and password
of the valid Cerity user
• Signing a record requires entering the user-id and password
of that user.
• A configurable inactivity timeout prevents impersonation after a
defined period without user activity. The currently logged on user
must re-enter user ID and password to unblock the system.
Figure 8
Audit trail and electronic signature
for results sign-off
Electronic signatures not based • Cerity uses NT security system, allowing reuse of the password
upon biometrics shall be used
policies defined in NT.
only by their genuine owners
Electronic signatures not based
upon biometrics shall be
administered and executed
to ensure that attempted use
of an individual’s electronic
signature by anyone other
than its genuine owner
requires collaboration of two
or more individuals.
• User account administration is only accessible
for authorized administrators.
• Based on NT security implementation
(policies, encryption, domains)
• Requires appropriate procedural controls
• Customer policy has to define, implement and maintain
a suitable password policy
• Configurable, multi level approval scheme
Controls must be used to
maintain the uniqueness of
each combined identification
code and password (11.300a)
• Implemented in NT user account system
• Customer policy has to define, implement and maintain
a suitable password policy
• Customer policy has to prohibit shared logons
Ensure that identification code • Based on standard NT password policies that are used by Cerity
and password issuances
• Procedural controls at the site
are periodically checked,
recalled or revised (11.300b)
Use of transaction safeguards
to prevent unauthorized use
of passwords (11.300d)
• Security relevant activities are subject to the Cerity audit trail
• System uses encryption mechanisms provided by the NT
operating system
Where are electronic
Configurable, depending on the organization's workflow.
signatures used in the system? Includes, but is not limited to, method changes, adding/changing
What information is stored by user permissions, result approval
the system for each use?
Are experiments and/or
Yes. The information can be retrieved and inspected in electronic
reports reviewed and approved form as well as on paper for investigations or regulatory inspections.
in the system?
What features does
the system provide to
administer user accounts?
24
Cerity users must be authenticated NT users. The Cerity system
administration console is based on the Microsoft Management
Console (MMC) and is used to set the Cerity specific permissions.
Can the system support
password aging?
Yes (reuses password policies defined
on the operating system level)
Can the system support
disabling/re-enabling
user accounts?
Yes, by directly reusing the account policy defined
in the NT operating system
Can the system support
account lockouts after
a defined number of failed
attempts to log-in?
Yes, see above.
How are failed login attempts
recorded by the system?
How does the system
administrator gain access
to information about failed
login attempts? How are
other security problems
identified, recorded and
accessed by the system
administrator?
Standard NT security, event log and password policies.
Warranty and
Support Contracts
Please contact your local support sales representative.
Warranty Period
Varies by country and can be from 1-3 years.
Extended Warranty
Available.
Software telephone support
Available.
Software materials subscription Available.
Figure 9
Computer based protocol for OQ/PV on an Agilent 1100 Series HPLC system
25
Services
Please contact your local NDS sales representative.
Standard Services
Installation, Familiarization, Education
Available Standard Courses
H2296A – Cerity Networked Data System Basic Operation
(Full Access Users) 1 day
H2297A – Cerity Networked Data System Advanced Operation
(Full Access Users) 2 day
H2298A – Cerity Networked Data System Application Administration
1 day
H2295A – Cerity Networked Data System Routine Operation 1 day
H2299A – Cerity Networked Data System Qualification Certificate
Program (availability planned for November 2002)
Personalized
Education Services
Customized education courses are available and can be delivered at
a central Agilent location or on-site.
Qualification Services
for NDS software
Computer-based installation qualification (IQ)
Computer-based operation qualification (OQ/PV)
Delivered by Agilent customer engineers
or a certified support provider.
Qualification Services for
chromatography equipment
Computer-based installation qualification (IQ)
Computer-based operation qualification (OQ/PV)
Delivered by Agilent customer engineers
or certified support provider.
Customization Services
Available.
Delivered through Agilent's Project Services Organization.
Please contact your local NDS sales representative.
Consulting Services
Available.
Delivered through Agilent's Project Services Organization.
Project Management Services
Available.
Project management according to development lifecycle.
Services comprise specification, design, implementation,
deployment, validation and support.
Delivered through Agilent's Project Services Organization.
Figure 10
The software qualification protocols are based on the Cerity TestManager, an automated
regression test utility
26
27
www.agilent.com/chem/nds
The information in this publication is subject to
change without notice.
Microsoft® and Microsoft Windows® are U.S.
registered trademarks of Microsoft Corp.
Oracle® is a U.S. registered trademark of Oracle
Corporation, Redwood City, California.
Copyright © 2002 Agilent Technologies
All Rights Reserved. Reproduction, adaptation or
translation without prior written permission is
prohibited, except as allowed under the copyright laws.
Published August 1, 2002
Publication Number 5988-7306EN
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