Roche cobas s 201 system User manual

Type
User manual
Validation Guide
for use with the
cobas s 201 system and
the cobas
®
TaqScreen
West Nile Virus Test
05128170190-01
Validation Guide for use with the cobas s 201 system Configuration B+.
This guide is designed for use with Roche PDM software version 1.1.8 and
AMPLILINK software version 3.1.2 only.
cobas s 201 system Validation Guide 09/2007, Revision 1.0
1
Table of Contents
Preface.......................................................................................................................................................... 5
Revision History .......................................................................................................................................................................... 5
Purpose of this Guide............................................................................................................................................................... 7
How to Use this Guide ............................................................................................................................................................. 8
Conventions Used in this Guide ........................................................................................................................................... 9
References..................................................................................................................................................................................10
Acronyms....................................................................................................................................................................................11
Glossary.......................................................................................................................................................................................12
Section 1: Hamilton Microlab STAR IVD Pipettor and Pooling Manager Workstation
Validation ................................................................................................................................................... 13
Traceability Matrix ................................................................................................................................... 14
Traceability Chart.....................................................................................................................................................................14
Installation Qualification (IQ) ................................................................................................................ 15
Overview......................................................................................................................................................................................15
Test Case HIQ-01: Pooling Manager Hardware and Software...............................................................................16
Test Case HIQ-02: Location Verification.........................................................................................................................19
Test Case HIQ-03: Environment Verification.................................................................................................................21
Test Case HIQ-04: Verification of Connections............................................................................................................23
Test Case HIQ-05: Safety and Training Verification...................................................................................................25
Test Case HIQ-06: Consumables ......................................................................................................................................27
Test Case HIQ-07: Documentation Verification...........................................................................................................28
Test Case HIQ-08: Communication Verification ..........................................................................................................29
Test Case HIQ-09: Verification of Application Security.............................................................................................31
Operational Qualification (OQ).............................................................................................................. 37
Overview......................................................................................................................................................................................37
Dependencies............................................................................................................................................................................39
Test Case HOQ-01: Primary Pools of 6.............................................................................................................................40
Test Case HOQ-02: Primary Pools of 1.............................................................................................................................50
Test Case HOQ-03: Manual Barcode Entry for Donor Tubes...................................................................................59
Test Case HOQ-04: Correcting S-tube Barcode Reading Errors ............................................................................68
Test Case HOQ-05: Manual Barcode Entry for an Archive Plate............................................................................77
Test Case HOQ-06: Correcting Loading Errors .............................................................................................................85
Test Case HOQ-07: Recovery from Control Pipetting Errors....................................................................................93
Test Case HOQ-08: Recovery from Sample Pipetting Errors................................................................................. 100
Test Case HOQ-09: Rejecting Pools............................................................................................................................... 109
Test Case HOQ-10: Availability of Archive Plate Wells............................................................................................ 117
Test Case HOQ-11: Resolution Pooling from Plate................................................................................................... 123
Test Case HOQ-12: Resolution Pooling from Tubes................................................................................................. 130
cobas s 201 system Validation Guide 09/2007, Revision 1.0
2
Test Case HOQ-13: Repeat Pooling from Plate.......................................................................................................... 138
Test Case HOQ-14: Repeat Pooling from Tubes........................................................................................................ 144
Test Case HOQ-15: Aborting a Pooling Run ............................................................................................................... 150
Performance Qualification (PQ)..........................................................................................................154
Overview................................................................................................................................................................................... 154
Section 2: COBAS
®
AmpliPrep Instrument and AMPLILINK Software Validation....................157
Traceability Matrix .................................................................................................................................158
Installation Qualification (IQ) ..............................................................................................................159
Overview................................................................................................................................................................................... 159
Materials................................................................................................................................................................................... 159
General Prerequisites .......................................................................................................................................................... 159
Dependencies......................................................................................................................................................................... 159
Test Case APIQ-01: Work Area Verification ................................................................................................................ 160
Test Case APIQ-02: Reagent Storage Area Verification.......................................................................................... 162
Test Case APIQ-03: Hardware and Software Verification ...................................................................................... 164
Test Case APIQ-04: Location Verification................................................................................................................... 169
Test Case APIQ-05: Environment Verification ........................................................................................................... 171
Test Case APIQ-06: Connections and Accessories................................................................................................. 173
Test Case APIQ-07: Safety and Training ..................................................................................................................... 175
Test Case APIQ-08: Documentation ............................................................................................................................. 177
Test Case APIQ-09: Consumables................................................................................................................................. 178
Test Case APIQ-10: Configuration Settings ............................................................................................................... 179
Test Case APIQ-11: Security............................................................................................................................................ 182
Operational Qualification (OQ)............................................................................................................188
Overview................................................................................................................................................................................... 188
Materials................................................................................................................................................................................... 188
Documentation ...................................................................................................................................................................... 188
General Prerequisites .......................................................................................................................................................... 189
Dependencies......................................................................................................................................................................... 190
Test Case APOQ-01: Loading Reagents....................................................................................................................... 191
Test Case APOQ-02: Loading Consumables............................................................................................................... 194
Test Case APOQ-03: Routine Sample Preparation Run.......................................................................................... 198
Test Case APOQ-04: Handling Loading Errors........................................................................................................... 206
Test Case APOQ-05: Handling Reagent Barcode Reading Errors....................................................................... 215
Test Case APOQ-06: Error Handling for Switched Controls.................................................................................. 218
Test Case APOQ-07: Error Handling for Reagents on Incorrect Rack............................................................... 225
Test Case APOQ-08: Error Handling for Empty Reagent Cassettes.................................................................... 233
Test Case APOQ-09: Error Handling for Expired Reagents ................................................................................... 236
Test Case APOQ-10: Examining System and Rack Status Indicators ................................................................ 239
Test Case APOQ-11: Status Indicators, Logs, and Problem Reports.................................................................. 241
cobas s 201 system Validation Guide 09/2007, Revision 1.0
3
Performance Qualification (PQ)..........................................................................................................245
Overview................................................................................................................................................................................... 245
Section 3: COBAS
®
TaqMan
®
Analyzer and AMPLILINK Software Validation..........................247
Traceability Matrix .................................................................................................................................248
Installation Qualification (IQ) ..............................................................................................................249
Overview................................................................................................................................................................................... 249
Materials................................................................................................................................................................................... 249
General Prerequisites .......................................................................................................................................................... 249
Dependencies......................................................................................................................................................................... 249
Test Case TMIQ-01: Work Area Verification ............................................................................................................... 250
Test Case TMIQ-02: Hardware and Software Verification ..................................................................................... 252
Test Case TMIQ-03: Location Verification.................................................................................................................. 256
Test Case TMIQ-04: Environment Verification .......................................................................................................... 258
Test Case TMIQ-05: Connections and Accessories ................................................................................................ 260
Test Case TMIQ-06: Safety and Training..................................................................................................................... 262
Test Case TMIQ-07: Documentation ............................................................................................................................ 264
Test Case TMIQ-08: Consumables ................................................................................................................................ 265
Test Case TMIQ-09: Configuration Settings............................................................................................................... 266
Test Case TMIQ-10: Security........................................................................................................................................... 269
Operational Qualification (OQ)............................................................................................................273
Overview................................................................................................................................................................................... 273
Materials................................................................................................................................................................................... 273
Documentation ...................................................................................................................................................................... 273
General Prerequisites .......................................................................................................................................................... 274
Dependencies......................................................................................................................................................................... 275
Test Case TMOQ-01: Analyzing Primary Pools of 6.................................................................................................. 276
Test Case TMOQ-02: Accepting Results on AMPLILINK Software .................................................................... 280
Test Case TMOQ-03: Blocked Samples........................................................................................................................ 284
Test Case TMOQ-04: Analyzing Primary Pools of 1.................................................................................................. 288
Test Case TMOQ-05: Analyzing Resolution Pools..................................................................................................... 293
Test Case TMOQ-06: Analyzing Additional Batches................................................................................................ 297
Test Case TMOQ-07: Status Indicators, Logs, and Problem Reports.................................................................301
Performance Qualification (PQ)..........................................................................................................305
Overview................................................................................................................................................................................... 305
Section 4: PDM Data Manager Software Validation.......................................................................307
Traceability Matrix .................................................................................................................................308
Installation Qualification (IQ) ..............................................................................................................309
Overview................................................................................................................................................................................... 309
Test Case PIQ-01: Data Manager Workstation and Software ............................................................................. 310
cobas s 201 system Validation Guide 09/2007, Revision 1.0
4
Test Case PIQ-02: Data Manager Communication.................................................................................................. 313
Test Case PIQ-03: PDM Server Hardware .................................................................................................................. 315
Test Case PIQ-04: Safety and Training ........................................................................................................................ 317
Test Case PIQ-05: Documentation ................................................................................................................................ 319
Test Case PIQ-06: Configuration Security................................................................................................................... 320
Operational Qualification (OQ)............................................................................................................324
Overview................................................................................................................................................................................... 324
Test Case POQ-01: Reviewing Results from Primary Pools of 6 .......................................................................... 327
Test Case POQ-02: Reviewing Results from Resolution Pools ............................................................................. 334
Test Case POQ-03: Reviewing Results from Primary Pools of 1 .......................................................................... 340
Test Case POQ-04: Reviewing Invalid Results............................................................................................................ 346
Performance Qualification (PQ)..........................................................................................................351
Overview................................................................................................................................................................................... 351
Appendix: The Validation Process ......................................................................................................355
Introduction............................................................................................................................................................................. 357
Defining User Requirements............................................................................................................................................. 358
Selecting the System............................................................................................................................................................ 358
Analyzing Risk........................................................................................................................................................................ 359
Preparing a Validation Plan............................................................................................................................................... 360
Executing the Validation Plan........................................................................................................................................... 361
Specifying Corrective Action............................................................................................................................................. 362
Using a Waiver Report ........................................................................................................................................................ 362
Preparing the Validation Report ...................................................................................................................................... 362
Forms......................................................................................................................................................................................... 363
Preface
cobas s 201 system Validation Guide 09/2007, Revision 1.0
5
Preface
Revision History
Manual Version Date Action
1.0 September 2007 Original document for Configuration B+
and WNV.
Roche Instrument Center AG
CH-6343 Rotkreuz
Switzerland
Distributed by
Roche Diagnostics
Indianapolis, IN 46256 USA
(For Technical Assistance call the
Roche Response Center
toll-free 1-800 526 1247)
Roche Diagnostics
H7V 4A2 Laval, Québec
(For Technical Assistance call:
Pour toute assistance technique,
appeler le: 1-877 273 3433)
Roche Diagnostics (Schweiz) AG
CH-6343 Rotkreuz
Roche Diagnostics
F-38240 Meylan
Roche Diagnostics GmbH
D-68298 Mannheim, Germany
Distributore in Italia:
Roche Diagnostics SpA
Piazza Durante 11
I-20131 Milano
Roche Diagnostics S.L.
E-08006 Barcelona
Distribuidor em Portugal:
Roche Farmacêutica Química, Lda
P-2700 Amadora
Preface
cobas s 201 system Validation Guide 09/2007, Revision 1.0
6
Questions or comments regarding the contents of this guide can be directed to the
address below or to your Roche representative.
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, California 94588-2722
ROCHE, AMPERASE, AMPLILINK, COBAS, AMPLIPREP, TAQSCREEN, and
TAQMAN are trademarks of Roche.
ROCHE RESPONSE CENTER is a servicemark of Roche.
Microlab is a registered trademark of Hamilton Company.
Microsoft, Windows, and Windows XP are either registered trademarks or trademarks of
Microsoft Corporation in the United States and/or other countries.
Pentium is a registered trademark of Intel Corporation.
Copyright © 2007. Roche Molecular Systems, Inc. All rights reserved.
Preface
cobas s 201 system Validation Guide 09/2007, Revision 1.0
7
Purpose of this Guide
The cobas s 201 system includes hardware, software, and reagents. This Validation Guide
assists users in establishing Quality Assurance (QA) procedures with regard to all the
cobas s 201 system components that are used when testing blood products.
The purpose of this Validation Guide is to assist users of the cobas s 201 system in creating
a site-specific Validation Plan to qualify their system according to current guidelines. This
Validation Guide should be used only as a guideline, and users may elect to use, modify,
or not use each section as they deem appropriate.
Refer to the cobas s 201 system Operator’s Manual for WNV for a complete description of
the cobas s 201 system. Refer to the cobas® TaqScreen WNV Package Insert for specific
instructions on collection, storage, and handling of samples.
Preface
cobas s 201 system Validation Guide 09/2007, Revision 1.0
8
How to Use this Guide
Preface
Lists the reference materials that were used to
prepare this Validation Guide and the terms and
acronyms that are used.
Hamilton Microlab
STAR IVD Pipettor
and Pooling Manager
Workstation
Provides sample test cases that can be used to
assist in preparing a Hamilton Microlab STAR
IVD Pipettor, PDM Pooling Wizard software, and
PDM Pooling Manager software Validation Plan
for your facility. The user can select those parts of
this section that are applicable for the validation
and modify them as needed.
COBAS® AmpliPrep
Instrument and Data
Station for
AMPLILINK Software
Provides sample test cases that can be used to
assist in preparing a COBAS® AmpliPrep
Instrument and AMPLILINK software Validation
Plan for your facility. The user can select those
parts of this section that are applicable for the
validation and modify them as needed.
COBAS® TaqMan®
Analyzer and Data
Station for
AMPLILINK Software
Provides sample test cases that can be used to
assist in preparing a COBAS® TaqMan® Analyzer
and AMPLILINK software Validation Plan for
your facility. The user can select those parts of
this section that are applicable for the validation
and modify them as needed.
Data Manager
Workstation
Provides sample test cases that can be used to
assist in preparing a PDM Data Manager and
Administrator Software Validation Plan for your
facility. The user can select those parts of this
section that are applicable for the validation and
modify them as needed.
Appendix
Provides an overview of the validation process
and describes how the validation plan is
developed. Templates for commonly used
validation forms are also provided.
Preface
cobas s 201 system Validation Guide 09/2007, Revision 1.0
9
Conventions Used in this Guide
Italics
Indicates a reference to another section of this guide or an
external document. For example:
Refer to the cobas s 201 system Operator’s Manual for WNV
for a complete description of the cobas s 201 system.
Italics are also used for field, screen, and dialog box titles. For
example:
The Begin Logon dialog box is displayed.
Bold
Emphasizes a term or component that is being described or
indicates a keyboard entry or mouse selection. For example:
Press F1 to display online Help.
Select Export from the File menu.
“Quotes” Designates keyboard input that should be typed exactly as
shown. For example:
Enter “GUEST” then click OK.
1 First Item
2 Second Item
Used to number procedures that should be performed
sequentially and to uniquely identify system requirements.
[Brackets] Indicates a cross-reference to an external document. Outside
source material used in the preparation of the Validation Guide
is listed in the References section. A bracketed category name
and sequential number precede each entry. For example the
first referenced FDA document is listed:
[FDA-1] CFR Title 21
> Separates command options in a multi-level command. For
example:
Select Control Panel > Help > About Windows
+ Indicates more than one key should be pressed
simultaneously. For example:
Press the Ctrl+Alt+Del keys.
Preface
cobas s 201 system Validation Guide 09/2007, Revision 1.0
10
References
(as of the date of this publication)
The following documents were used as sources of information for this Validation Guide:
[AABB-1] Facts About Blood And Blood Banking, AABB Web site:
www.aabb.org/All_About_Blood/FAQs/aabb_faqs.htm
[FDA-1] U.S. Government Code of Federal Regulations (CFR) Title 21 - Food and
Drugs.
[FDA-2] General Principles of Software Validation; Final Guidance for Industry
and FDA Staff (January 11, 2002).
[FDA-3] Glossary of Computerized System and Software Development
Terminology, 1995.
[FDA-4] Guideline on General Principles of Process Validation, May, 1987.
[FDA-5] Docket No. 91N-0450, Guideline for Quality Assurance in Blood
Establishments, July 11, 1995.
[FDA-6] CBER publication "Commemorating 100 Years of Biologics Regulation”,
March 2002.
[FDA-7] CBER publication "Guidance for Industry Q7A Good Manufacturing
Practice Guidance for Active Pharmaceutical Ingredients”, August 2001.
[FDA-8] Medical Device Quality System Manual, HHS Publication FDA 97-4179,
December 1996. Available online at www.fda.gov/cdrh/qsr/
[FDA-9] Development of West Nile virus Testing and Donor screening as a Model
for Screening Bioterrorist Agents, Hira Nakhasi, Ph.D., Director,
DETTD/OBRR, CBER, FDA
[FMEA-1] An Introduction to Risk/Hazard Analysis for Medical Devices; Daniel
Kamm, P.E., C.Q.A.
[GAMP-1] GAMP Good Practice Guide: Validation of Process Control Systems
(VPCS), October 2003.
[GOV-1] GPO Access Web site: http://www.gpoaccess.gov/cfr/index.html. A service
of the U.S. Government Printing Office.
[CEFIC-1] CEFIC Task Force – Computer Validation Guide, ver. 2, December, 2002.
[IEEE-1] IEEE-STD-829-1998; IEEE Standard for Software Test Documentation,
Institute of Electrical and Electronics Engineers, New York.
[ISBT-1] Guidelines for validation and maintaining the validation state of
automated systems in blood banking, July 2003.
[RMS-1] Roche
Diagnostics Web site: www.roche-diagnostics.com/quality.html (2006)
.
[RMS-2] cobas s 201 system Operator’s Manual for WNV
[RMS-3] cobas s 201 system Facilities Guide
Preface
cobas s 201 system Validation Guide 09/2007, Revision 1.0
11
Acronyms
The following acronyms are used in this guide:
CBER Center for Biologics Evaluation and Research
CFR Code of Federal Regulations
cGMP Current Good Manufacturing Practices
DNA Deoxyribonucleic Acid
DR Discrepancy Report
EC External Control
FDA U.S. Food and Drug Administration
FMEA Failure Mode Effects Analysis
GAMP Good Automated Manufacturing Practices
IEEE Institute of Electrical and Electronics Engineers
IQ Installation Qualification
IRQ Interrupt Request
ISBT International Society for Blood Transfusion
LAN Local Area Network
LIS Laboratory Information System
MB Megabyte
MHz Megahertz
NAT Nucleic Acid Testing
NCCLS National Committee for Clinical Laboratory Standards
OQ Operational Qualification
OS Operating System
PCR Polymerase Chain Reaction
PQ Performance Qualification
QA Quality Assurance
RMS Roche Molecular Systems, Inc.
RNA Ribonucleic Acid
TCx Thermal Cycler A, B, C, or D
URS User Requirements Specification
V Volts
VAC Volts Alternating Current
WNV West Nile Virus
Preface
cobas s 201 system Validation Guide 09/2007, Revision 1.0
12
Glossary
Code of Federal
Regulations
The Code of Federal Regulations (CFR) is the codification of the general
and permanent rules published in the Federal Register by the executive
departments and agencies of the Federal Government. It is divided into 50
titles that represent broad areas subject to Federal regulation.
1
CFR Title 21, FDA, is referenced in this guide.
Concurrent
Validation
Testing that thoroughly monitors the process, allowing tested product to
be released for use. This method can be used when a previously validated
process is modified.
Installation
Qualification
Documented verification that the system, including all software and
hardware components, has been installed correctly.
Operational
Qualification
Documented verification that the system meets all its requirements under
all anticipated operating conditions including boundary and extreme test
cases.
Performance
Qualification
Documented verification that the system produces acceptable results
under normal operating conditions in the customer environment.
Prospective
Validation
Testing that is performed before the product is used.
Quality
Assurance
The actions, planned and performed, to provide confidence that all
systems and components that influence the quality of the product are
working as expected individually and collectively.
2
Quality Control The operational techniques and procedures used to achieve quality
requirements.
2
Retrospective
Validation
Testing that is performed on representative batches of the product after
the product is released. This method is reserved for a well-established
process that has undergone a change that does not affect product quality.
Validation Establishing documented evidence that a process will consistently
perform effectively according to its intended use.
Validation Plan The written and approved document of an experimental sequence of tests,
that when executed as prescribed, are intended to produce documented
evidence that the equipment or system conforms to user needs and
intended uses, and that the particular requirements implemented can be
consistently fulfilled.
For additional information, refer to the Medical Device Quality Systems Manual.
3
1
[GOV-1]
2
[FDA-3]
3
[FDA-8]
cobas s 201 system Validation Guide 09/2007, Revision 1.0
13
Section 1: Hamilton Microlab
STAR IVD Pipettor and Pooling Manager Workstation
Validation
This section can be used to assist in preparing a Hamilton Microlab STAR IVD Pipettor, PDM Pooling Wizard software, and
PDM Pooling Manager software Validation Plan for your facility.
The contents of this section and the test cases are intended only to be used as a guide. The user can select those parts of this
section that are applicable for the validation and modify them as needed.
Hamilton Microlab STAR and PDM Pooling Manager Software Validation
Traceability Matrix Traceability Chart
cobas s 201 system Validation Guide 09/2007, Revision 1.0
14
Traceability Matrix
Requirements for the Hamilton Microlab STAR IVD Pipettor, PDM Pooling Wizard software, and PDM Pooling Manager software
and the test case(s) that validate each requirement are summarized below.
Traceability Chart
Requirements Test Case(s)
Hardware and Software HIQ-01
Location HIQ-02
Environment HIQ-03
Connections and Accessories HIQ-04
Safety and Training HIQ-05
Consumables HIQ-06
Documentation HIQ-07
Configuration Settings HIQ-08
Security HIQ-09
Operation HOQ-01 through HOQ-15
Validity Checking HOQ-01, HOQ-02, HOQ-10 through HOQ-15
Results Analysis See POQ-01 through POQ-04
Data Management and Reporting See POQ-01 through POQ-04
Audit Log See POQ-01 through POQ-04
Alarms HOQ-03 through HOQ-08
Throughput and Capacity HOQ-01, HOQ-02
Hamilton Microlab STAR and PDM Pooling Manager Software Validation
Installation Qualification (IQ) Overview
cobas s 201 system Validation Guide 09/2007, Revision 1.0
15
Installation Qualification (IQ)
Overview
The Installation Qualification (IQ) verifies that the Hamilton Microlab STAR IVD Pipettor and Pooling Manager Workstation
software have been installed correctly.
Materials
No special materials are required to perform the IQ.
General Prerequisites
Each IQ test case lists prerequisites required to begin the test case. Additionally, all IQ testing assumes that:
1 The vendor properly installed the system.
2 The operator is familiar with general computer operation and the Windows operating system.
Dependencies
All test cases in the IQ section are designed so they can be run independently.
Hamilton Microlab STAR and PDM Pooling Manager Software Validation
Installation Qualification (IQ) Test Case HIQ-01: Pooling Manager Hardware and Software
cobas s 201 system Validation Guide 09/2007, Revision 1.0
16
Test Case HIQ-01: Pooling Manager Hardware and Software
Purpose
This test case verifies that the correct hardware and software is installed for the PDM Pooling Manager workstation.
Prerequisites
This test case assumes the operator:
Is familiar with the Windows XP operating system.
Has a user ID and password that allow access to the PDM Pooling Wizard and PDM Pooling Manager software.
Record the user ID: _________________________________
Acceptance Criteria
This test case is complete and passes when the Expected Result has been obtained and entered in the Observed Result box, Pass is
circled in the Pass/Fail column for each step, and (if required by your facility) each completed step is initialed and dated.
Procedure
Step Action Expected Result Observed Result Pass/Fail By/Date
1
Power on the Pooling Manager
workstation if it is powered off.
The cobas s 201 Logon dialog box is
displayed.
Pass Fail
________
________
2
If the Logon dialog box is not
displayed, press Ctrl+Alt+Del.
The cobas s 201 Logon dialog box is
displayed.
Pass Fail
________
________
3
Enter the assigned user ID and
password and then click OK.
The Windows XP operating system
desktop is displayed.
Pass Fail
________
________
Hamilton Microlab STAR and PDM Pooling Manager Software Validation
Installation Qualification (IQ) Test Case HIQ-01: Pooling Manager Hardware and Software
cobas s 201 system Validation Guide 09/2007, Revision 1.0
17
Step Action Expected Result Observed Result Pass/Fail By/Date
4 Double-click the Pooling Wizard
icon located on the desktop.
Record the software version for
Roche Pooling Wizard software.
The Pooling Wizard main screen is
displayed. The software version is
displayed in the title bar.
Pooling Wizard software version:
__________________________________
Pass Fail
________
________
5 Click Exit.
The PDM Pooling Wizard application
closes.
Pass Fail
________
________
6 Double-click the Pooling
Manager icon located on the
desktop.
Record the software version for
Roche Pooling Manager software.
The Pooling Manager Query tab is
displayed. The software version is
displayed in the title bar.
PDM Pooling Manager software version:
__________________________________
Pass Fail
________
________
7 Click Exit and then click OK to
acknowledge the confirmation.
The PDM Pooling Manager application
closes.
Pass Fail
________
________
8 Click Start on the Windows
operating system taskbar. Select
Settings and then select Control
Panel. Double-click the System
icon in the Control Panel.
The General tab of the System Properties
dialog box is displayed. It shows that the
following peripheral hardware
specifications for the Pooling Manager
Workstation (described in the cobas s
201 system Facilities Guide) have been
met:
PC that runs the Windows operating
system
Correct operating system
Sufficient processing capacity
Sufficient memory
Pass Fail
________
________
9 Click OK to close the System
Properties dialog box and then
select File > Close to close the
Control Panel.
Windows operating system desktop
displayed.
Pass Fail
________
________
Hamilton Microlab STAR and PDM Pooling Manager Software Validation
Installation Qualification (IQ) Test Case HIQ-01: Pooling Manager Hardware and Software
cobas s 201 system Validation Guide 09/2007, Revision 1.0
18
Step Action Expected Result Observed Result Pass/Fail By/Date
10 Select Start > Help and Support
from the Windows operating
system taskbar.
The Help and Support Center dialog box is
displayed.
Pass Fail
________
________
11
Type “Installed hardware” in the
Search text box and press Enter.
Search results returned. Pass Fail
________
________
12
Select Get information about your
computer and then select Find
information about the hardware
installed on this computer.
The My Computer Information – Hardware
report is displayed. It shows that the
following peripheral hardware
specifications for the Pooling Manager
Workstation (described in the cobas s
201 system Facilities Guide) have been
met:
Disk drives
Monitor
Network cards
Printer
Pass Fail
________
________
13
Close the Help and Support Center
dialog box.
The Windows operating system desktop is
displayed.
Pass Fail
________
________
Results
Acceptable ________ Unacceptable _________
Comments ________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________________
Performed By _______________________________________ Date _________________
Verified By _______________________________________ Date _________________
  • Page 1 1
  • Page 2 2
  • Page 3 3
  • Page 4 4
  • Page 5 5
  • Page 6 6
  • Page 7 7
  • Page 8 8
  • Page 9 9
  • Page 10 10
  • Page 11 11
  • Page 12 12
  • Page 13 13
  • Page 14 14
  • Page 15 15
  • Page 16 16
  • Page 17 17
  • Page 18 18
  • Page 19 19
  • Page 20 20
  • Page 21 21
  • Page 22 22
  • Page 23 23
  • Page 24 24
  • Page 25 25
  • Page 26 26
  • Page 27 27
  • Page 28 28
  • Page 29 29
  • Page 30 30
  • Page 31 31
  • Page 32 32
  • Page 33 33
  • Page 34 34
  • Page 35 35
  • Page 36 36
  • Page 37 37
  • Page 38 38
  • Page 39 39
  • Page 40 40
  • Page 41 41
  • Page 42 42
  • Page 43 43
  • Page 44 44
  • Page 45 45
  • Page 46 46
  • Page 47 47
  • Page 48 48
  • Page 49 49
  • Page 50 50
  • Page 51 51
  • Page 52 52
  • Page 53 53
  • Page 54 54
  • Page 55 55
  • Page 56 56
  • Page 57 57
  • Page 58 58
  • Page 59 59
  • Page 60 60
  • Page 61 61
  • Page 62 62
  • Page 63 63
  • Page 64 64
  • Page 65 65
  • Page 66 66
  • Page 67 67
  • Page 68 68
  • Page 69 69
  • Page 70 70
  • Page 71 71
  • Page 72 72
  • Page 73 73
  • Page 74 74
  • Page 75 75
  • Page 76 76
  • Page 77 77
  • Page 78 78
  • Page 79 79
  • Page 80 80
  • Page 81 81
  • Page 82 82
  • Page 83 83
  • Page 84 84
  • Page 85 85
  • Page 86 86
  • Page 87 87
  • Page 88 88
  • Page 89 89
  • Page 90 90
  • Page 91 91
  • Page 92 92
  • Page 93 93
  • Page 94 94
  • Page 95 95
  • Page 96 96
  • Page 97 97
  • Page 98 98
  • Page 99 99
  • Page 100 100
  • Page 101 101
  • Page 102 102
  • Page 103 103
  • Page 104 104
  • Page 105 105
  • Page 106 106
  • Page 107 107
  • Page 108 108
  • Page 109 109
  • Page 110 110
  • Page 111 111
  • Page 112 112
  • Page 113 113
  • Page 114 114
  • Page 115 115
  • Page 116 116
  • Page 117 117
  • Page 118 118
  • Page 119 119
  • Page 120 120
  • Page 121 121
  • Page 122 122
  • Page 123 123
  • Page 124 124
  • Page 125 125
  • Page 126 126
  • Page 127 127
  • Page 128 128
  • Page 129 129
  • Page 130 130
  • Page 131 131
  • Page 132 132
  • Page 133 133
  • Page 134 134
  • Page 135 135
  • Page 136 136
  • Page 137 137
  • Page 138 138
  • Page 139 139
  • Page 140 140
  • Page 141 141
  • Page 142 142
  • Page 143 143
  • Page 144 144
  • Page 145 145
  • Page 146 146
  • Page 147 147
  • Page 148 148
  • Page 149 149
  • Page 150 150
  • Page 151 151
  • Page 152 152
  • Page 153 153
  • Page 154 154
  • Page 155 155
  • Page 156 156
  • Page 157 157
  • Page 158 158
  • Page 159 159
  • Page 160 160
  • Page 161 161
  • Page 162 162
  • Page 163 163
  • Page 164 164
  • Page 165 165
  • Page 166 166
  • Page 167 167
  • Page 168 168
  • Page 169 169
  • Page 170 170
  • Page 171 171
  • Page 172 172
  • Page 173 173
  • Page 174 174
  • Page 175 175
  • Page 176 176
  • Page 177 177
  • Page 178 178
  • Page 179 179
  • Page 180 180
  • Page 181 181
  • Page 182 182
  • Page 183 183
  • Page 184 184
  • Page 185 185
  • Page 186 186
  • Page 187 187
  • Page 188 188
  • Page 189 189
  • Page 190 190
  • Page 191 191
  • Page 192 192
  • Page 193 193
  • Page 194 194
  • Page 195 195
  • Page 196 196
  • Page 197 197
  • Page 198 198
  • Page 199 199
  • Page 200 200
  • Page 201 201
  • Page 202 202
  • Page 203 203
  • Page 204 204
  • Page 205 205
  • Page 206 206
  • Page 207 207
  • Page 208 208
  • Page 209 209
  • Page 210 210
  • Page 211 211
  • Page 212 212
  • Page 213 213
  • Page 214 214
  • Page 215 215
  • Page 216 216
  • Page 217 217
  • Page 218 218
  • Page 219 219
  • Page 220 220
  • Page 221 221
  • Page 222 222
  • Page 223 223
  • Page 224 224
  • Page 225 225
  • Page 226 226
  • Page 227 227
  • Page 228 228
  • Page 229 229
  • Page 230 230
  • Page 231 231
  • Page 232 232
  • Page 233 233
  • Page 234 234
  • Page 235 235
  • Page 236 236
  • Page 237 237
  • Page 238 238
  • Page 239 239
  • Page 240 240
  • Page 241 241
  • Page 242 242
  • Page 243 243
  • Page 244 244
  • Page 245 245
  • Page 246 246
  • Page 247 247
  • Page 248 248
  • Page 249 249
  • Page 250 250
  • Page 251 251
  • Page 252 252
  • Page 253 253
  • Page 254 254
  • Page 255 255
  • Page 256 256
  • Page 257 257
  • Page 258 258
  • Page 259 259
  • Page 260 260
  • Page 261 261
  • Page 262 262
  • Page 263 263
  • Page 264 264
  • Page 265 265
  • Page 266 266
  • Page 267 267
  • Page 268 268
  • Page 269 269
  • Page 270 270
  • Page 271 271
  • Page 272 272
  • Page 273 273
  • Page 274 274
  • Page 275 275
  • Page 276 276
  • Page 277 277
  • Page 278 278
  • Page 279 279
  • Page 280 280
  • Page 281 281
  • Page 282 282
  • Page 283 283
  • Page 284 284
  • Page 285 285
  • Page 286 286
  • Page 287 287
  • Page 288 288
  • Page 289 289
  • Page 290 290
  • Page 291 291
  • Page 292 292
  • Page 293 293
  • Page 294 294
  • Page 295 295
  • Page 296 296
  • Page 297 297
  • Page 298 298
  • Page 299 299
  • Page 300 300
  • Page 301 301
  • Page 302 302
  • Page 303 303
  • Page 304 304
  • Page 305 305
  • Page 306 306
  • Page 307 307
  • Page 308 308
  • Page 309 309
  • Page 310 310
  • Page 311 311
  • Page 312 312
  • Page 313 313
  • Page 314 314
  • Page 315 315
  • Page 316 316
  • Page 317 317
  • Page 318 318
  • Page 319 319
  • Page 320 320
  • Page 321 321
  • Page 322 322
  • Page 323 323
  • Page 324 324
  • Page 325 325
  • Page 326 326
  • Page 327 327
  • Page 328 328
  • Page 329 329
  • Page 330 330
  • Page 331 331
  • Page 332 332
  • Page 333 333
  • Page 334 334
  • Page 335 335
  • Page 336 336
  • Page 337 337
  • Page 338 338
  • Page 339 339
  • Page 340 340
  • Page 341 341
  • Page 342 342
  • Page 343 343
  • Page 344 344
  • Page 345 345
  • Page 346 346
  • Page 347 347
  • Page 348 348
  • Page 349 349
  • Page 350 350
  • Page 351 351
  • Page 352 352
  • Page 353 353
  • Page 354 354
  • Page 355 355
  • Page 356 356
  • Page 357 357
  • Page 358 358
  • Page 359 359
  • Page 360 360
  • Page 361 361
  • Page 362 362
  • Page 363 363
  • Page 364 364
  • Page 365 365
  • Page 366 366
  • Page 367 367
  • Page 368 368
  • Page 369 369
  • Page 370 370
  • Page 371 371
  • Page 372 372
  • Page 373 373
  • Page 374 374
  • Page 375 375
  • Page 376 376
  • Page 377 377
  • Page 378 378
  • Page 379 379
  • Page 380 380
  • Page 381 381
  • Page 382 382

Roche cobas s 201 system User manual

Type
User manual

Ask a question and I''ll find the answer in the document

Finding information in a document is now easier with AI