Roche cobas s 201 system 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

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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

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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

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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

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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

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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.

Preface

cobas s 201 system Validation Guide 09/2007, Revision 1.0

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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

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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

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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

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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

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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

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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

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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

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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 _________________

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Roche cobas s 201 system User manual

Roche cobas s 201 system User manual

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