Roche cobas s 201 system User manual

cobas s 201 System

Validation Guide

for use with Small Pools

(Pools of 1 and 6)

Configuration C MR1

05922151190-02

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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Table of Contents

Preface.......................................................................................................................................................... 7

Revision History .......................................................................................................................................................................... 7

Purpose of this Guide............................................................................................................................................................... 9

How to Use this Guide ...........................................................................................................................................................10

Conventions Used in this Guide .........................................................................................................................................11

References..................................................................................................................................................................................12

Acronyms....................................................................................................................................................................................13

Glossary.......................................................................................................................................................................................14

Section 1: Hamilton Microlab STAR IVD / STARlet IVD Pipettor and Pooling Management

Workstation Validation............................................................................................................................ 15

Traceability Matrix ................................................................................................................................... 16

Traceability Chart.....................................................................................................................................................................16

Installation Qualification (IQ) ................................................................................................................ 17

Overview......................................................................................................................................................................................17

Test Case HIQ-01: Pooling Manager Hardware and Software...............................................................................18

Test Case HIQ-02: Location Verification.........................................................................................................................20

Test Case HIQ-03: Environment Verification.................................................................................................................22

Test Case HIQ-04: Verification of Connections............................................................................................................24

Test Case HIQ-05: Safety and Training Verification...................................................................................................26

Test Case HIQ-06: Consumables ......................................................................................................................................28

Test Case HIQ-07: Documentation Verification...........................................................................................................29

Test Case HIQ-08: Configuration Settings.....................................................................................................................30

Test Case HIQ-09: Verification of Application Security.............................................................................................32

Operational Qualification (OQ).............................................................................................................. 35

Overview......................................................................................................................................................................................35

Dependencies............................................................................................................................................................................37

Test Case HOQ-01: Primary Pools of 6.............................................................................................................................38

Test Case HOQ-02: Primary Pools of 1.............................................................................................................................47

Test Case HOQ-03: Manual Barcode Entry for Donor Tubes...................................................................................57

Test Case HOQ-04: Simultaneous Pools of 6.................................................................................................................62

Test Case HOQ-05: Manual Barcode Entry for a Library Plate................................................................................72

Test Case HOQ-06: Correcting Loading Errors .............................................................................................................76

Test Case HOQ-07: Recovery from Control Pipetting Errors....................................................................................82

Test Case HOQ-08: Recovery from Sample Pipetting Errors (Library Plates Enabled)...................................87

Test Case HOQ-09: Recovery from Sample Pipetting Errors (Library Plates Disabled)..................................94

Test Case HOQ-10: Rejecting Pools and Issuing Change Requests .................................................................. 100

Test Case HOQ-11: Rejecting Library Plate Wells..................................................................................................... 106

Test Case HOQ-12: Resolution Pooling (Library Plates Enabled)........................................................................ 111

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Test Case HOQ-13: Resolution Pooling (Library Plates Disabled) ...................................................................... 118

Test Case HOQ-14: Repeat Pooling (Library Plates Enabled)............................................................................... 124

Test Case HOQ-15: Repeat Pooling (Library Plates Disabled) ............................................................................. 131

Test Case HOQ-16: Correcting S-tube Barcode Reading Errors ......................................................................... 137

Test Case HOQ-17: Aborting a Pooling Run ............................................................................................................... 146

Performance Qualification (PQ)..........................................................................................................151

Overview................................................................................................................................................................................... 151

Section 2: COBAS

®

AmpliPrep Instrument, Optional Docking Station, and AMPLILINK

Software Validation................................................................................................................................155

Traceability Matrix .................................................................................................................................156

Installation Qualification (IQ) ..............................................................................................................157

Overview................................................................................................................................................................................... 157

Materials................................................................................................................................................................................... 157

General Prerequisites .......................................................................................................................................................... 157

Dependencies......................................................................................................................................................................... 157

Test Case APIQ-01: Work Area Verification ................................................................................................................ 158

Test Case APIQ-02: Reagent Storage Area Verification.......................................................................................... 160

Test Case APIQ-03: Hardware and Software Verification ...................................................................................... 162

Test Case APIQ-04: Location Verification................................................................................................................... 165

Test Case APIQ-05: Environment Verification ........................................................................................................... 167

Test Case APIQ-06: Connections and Accessories................................................................................................. 169

Test Case APIQ-07: Safety and Training ..................................................................................................................... 171

Test Case APIQ-08: Documentation ............................................................................................................................. 173

Test Case APIQ-09: Consumables................................................................................................................................. 174

Test Case APIQ-10: Configuration Settings ............................................................................................................... 175

Test Case APIQ-11: Security............................................................................................................................................ 178

Operational Qualification (OQ)............................................................................................................183

Overview................................................................................................................................................................................... 183

Materials................................................................................................................................................................................... 183

Documentation ...................................................................................................................................................................... 183

General Prerequisites .......................................................................................................................................................... 184

Dependencies......................................................................................................................................................................... 185

Test Case APOQ-01: Loading Reagents....................................................................................................................... 186

Test Case APOQ-02: Loading Consumables............................................................................................................... 189

Test Case APOQ-03: Routine Sample Preparation Run .......................................................................................... 193

Test Case APOQ-04: Handling Loading Errors........................................................................................................... 202

Test Case APOQ-05: Handling Reagent Barcode Reading Errors....................................................................... 213

Test Case APOQ-06: Error Handling for Switched Controls.................................................................................. 216

Test Case APOQ-07: Error Handling for Reagents on Incorrect Rack............................................................... 222

Test Case APOQ-08: Error Handling for Empty Reagent Cassettes.................................................................... 231

Test Case APOQ-09: Error Handling for Expired Reagents ................................................................................... 234

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Test Case APOQ-10: Examining System and Rack Status Indicators ................................................................ 237

Test Case APOQ-11: Status Indicators, Logs, and Problem Reports.................................................................. 239

Performance Qualification (PQ)..........................................................................................................243

Overview................................................................................................................................................................................... 243

Section 3: COBAS

®

TaqMan

®

Analyzer and AMPLILINK Software Validation..........................245

Traceability Matrix .................................................................................................................................246

Installation Qualification (IQ) ..............................................................................................................247

Overview................................................................................................................................................................................... 247

Materials................................................................................................................................................................................... 247

General Prerequisites .......................................................................................................................................................... 247

Dependencies......................................................................................................................................................................... 247

Test Case TMIQ-01: Work Area Verification ............................................................................................................... 248

Test Case TMIQ-02: Hardware and Software Verification ..................................................................................... 250

Test Case TMIQ-03: Location Verification.................................................................................................................. 253

Test Case TMIQ-04: Environment Verification .......................................................................................................... 255

Test Case TMIQ-05: Connections and Accessories ................................................................................................ 257

Test Case TMIQ-06: Safety and Training..................................................................................................................... 259

Test Case TMIQ-07: Documentation ............................................................................................................................ 261

Test Case TMIQ-08: Consumables................................................................................................................................ 262

Test Case TMIQ-09: Configuration Settings............................................................................................................... 263

Test Case TMIQ-10: Security........................................................................................................................................... 266

Operational Qualification (OQ)............................................................................................................271

Overview................................................................................................................................................................................... 271

Materials................................................................................................................................................................................... 271

Documentation ...................................................................................................................................................................... 271

General Prerequisites .......................................................................................................................................................... 272

Dependencies......................................................................................................................................................................... 273

Test Case TMOQ-01: Analyzing Primary Pools of 6.................................................................................................. 274

Test Case TMOQ-02: Accepting Results on AMPLILINK Software .................................................................... 278

Test Case TMOQ-03: Blocked Samples........................................................................................................................ 282

Test Case TMOQ-04: Analyzing Primary Pools of 1.................................................................................................. 287

Test Case TMOQ-05: Analyzing Resolution Pools..................................................................................................... 292

Test Case TMOQ-06: Analyzing Additional Batches................................................................................................ 296

Test Case TMOQ-07: Status Indicators, Logs, and Problem Reports.................................................................300

Performance Qualification (PQ)..........................................................................................................305

Overview................................................................................................................................................................................... 305

Section 4: Roche PDM Data Manager Software Validation..........................................................307

Traceability Matrix .................................................................................................................................308

Installation Qualification (IQ) ..............................................................................................................309

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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Overview................................................................................................................................................................................... 309

Test Case PIQ-01: Data Management Workstation and Software.....................................................................310

Test Case PIQ-02: Data Manager Communication.................................................................................................. 312

Test Case PIQ-03: PDM Server Hardware .................................................................................................................. 314

Test Case PIQ-04: Safety and Training ........................................................................................................................ 316

Test Case PIQ-05: Documentation ................................................................................................................................ 318

Test Case PIQ-06: Configuration Security................................................................................................................... 319

Operational Qualification (OQ)............................................................................................................325

Overview................................................................................................................................................................................... 325

Test Case POQ-01: Reviewing Results from Primary Pools of 6 .......................................................................... 328

Test Case POQ-02: Reviewing Results from Resolution Pools ............................................................................. 336

Test Case POQ-03: Reviewing Results from Primary Pools of 1 .......................................................................... 341

Test Case POQ-04: Reviewing Invalid Results............................................................................................................ 346

Test Case POQ-05: Defining UDECs.............................................................................................................................. 350

Performance Qualification (PQ)..........................................................................................................355

Overview................................................................................................................................................................................... 355

Appendix: The Validation Process ......................................................................................................359

Introduction............................................................................................................................................................................. 361

Defining User Requirements............................................................................................................................................. 362

Selecting the System............................................................................................................................................................ 362

Analyzing Risk........................................................................................................................................................................ 363

Preparing a Validation Plan............................................................................................................................................... 364

Executing the Validation Plan........................................................................................................................................... 365

Specifying Corrective Action............................................................................................................................................. 366

Using a Waiver Report ........................................................................................................................................................ 366

Preparing the Validation Report ...................................................................................................................................... 366

Forms......................................................................................................................................................................................... 367

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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Preface

Revision History

Manual Version Date Action

1.0 August 2009 Original document.

2.0 October 2009 Addition of Configuration to Title Page

Roche Diagnostics Ltd.

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, Quebec

(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

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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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, COBAS S, AMPLIPREP, TAQSCREEN,

and TAQMAN are trademarks of a member of the Roche Group.

ROCHE RESPONSE CENTER is a servicemark of a member of the Roche Group.

HP and StorageWorks are trademarks of Hewlett-Packard Company in the United States

and/or other countries.

Microlab is a registered trademark of Hamilton Company.

Microsoft and Windows are either registered trademarks or trademarks of Microsoft

Corporation in the United States and/or other countries.

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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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 Manuals for a complete description of the

cobas s 201 system. Refer to the assay-specific package inserts for instructions on

collection, storage, and handling of samples.

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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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 / STARlet

IVD Pipettor and

Pooling Management

Workstation

Provides sample test cases that can be used to

assist in preparing a Hamilton Microlab STAR

IVD / STARlet IVD Pipettor, Roche PDM Pooling

Wizard software, and Roche 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, Optional

Docking Station, and

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

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.

Roche PDM Data

Manager Software

Provides sample test cases that can be used to

assist in preparing a Roche 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.

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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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 Hardware and Software

Reference Manual 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.

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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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 Use with Small Pools

[RMS-3] cobas s 201 system Hardware and Software Reference Manual

[RMS-4] cobas s 201 system PDM Software Administrator’s Guide

[RMS-5] cobas s 201 system Facilities Guide

[RMS-6] cobas s 201 system Operator’s Manual Supplement for Use of the

Docking Station

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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Acronyms

The following acronyms are used in this guide:

CBER Center for Biologics Evaluation and Research

CFR Code of Federal Regulations

DNA Deoxyribonucleic Acid

DR Discrepancy Report

FDA U.S. Food and Drug Administration

FMEA Failure Mode Effects Analysis

GAMP Good Automated Manufacturing Practices

HBV Hepatitis B Virus

HCV Hepatitis C Virus

HIV Human Immunodeficiency Virus

IEEE Institute of Electrical and Electronics Engineers

IQ Installation Qualification

ISBT International Society for Blood Transfusion

LAN Local Area Network

LIS Laboratory Information System

MB Megabyte

MHz Megahertz

MPX Multiplexed set of targets: HCV, HBV, HIV-1 (Group M and O), HIV-2

OQ Operational Qualification

PCR Polymerase Chain Reaction

PQ Performance Qualification

QA Quality Assurance

RMEC Roche-Manufactured External Control

RMS Roche Molecular Systems, Inc.

RNA Ribonucleic Acid

TCx Thermal Cycler A, B, C, or D

UDEC User-Defined External Control

URS User Requirements Specification

V Volts

VAC Volts Alternating Current

WNV West Nile Virus

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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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 system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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Section 1: Hamilton Microlab

STAR IVD / STARlet IVD Pipettor and Pooling

Management Workstation Validation

This section can be used to assist in preparing a Hamilton Microlab STAR IVD / STARlet 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 IVD / STARlet IVD Pipettor and Roche PDM Pooling Manager Software Validation

Traceability Matrix Traceability Chart

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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Traceability Matrix

Requirements for the Hamilton Microlab STAR IVD / STARlet 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-17

Validity Checking HOQ-06 through HOQ-09, HOQ-14, HQO-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-09

Throughput and Capacity HOQ-01, HOQ-02, HOQ-04

Hamilton Microlab STAR IVD / STARlet IVD Pipettor and Roche PDM Pooling Manager Software Validation

Installation Qualification (IQ) Overview

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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Installation Qualification (IQ)

Overview

The Installation Qualification (IQ) verifies that the Hamilton Microlab STAR IVD / STARlet IVD Pipettor and Pooling Management

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 IVD / STARlet IVD Pipettor and Roche PDM Pooling Manager Software Validation

Installation Qualification (IQ) Test Case HIQ-01: Pooling Manager Hardware and Software

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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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 Pooling Management Workstation.

Prerequisites

This test case assumes the operator:

• Has a login ID and password that allow access to the PDM Pooling Wizard and PDM Pooling Manager.

Record the login 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 Management

Workstation if it is powered off.

A prompt is displayed to press the

CTRL+ALT+DEL keys simultaneously to

logon.

Pass Fail

________

2 Press CTRL+ALT+DEL.

The Welcome to Roche PDM dialog box is

displayed.

Pass Fail

________

3

Enter the login ID and password

recorded in the Prerequisites

section and then click OK.

The PDM Pooling Manager is started and

the Query tab is displayed. The software

version is displayed in the title bar.

PDM Pooling Manager software version:

__________________________________

Pass Fail

________

Hamilton Microlab STAR IVD / STARlet IVD Pipettor and Roche PDM Pooling Manager Software Validation

Installation Qualification (IQ) Test Case HIQ-01: Pooling Manager Hardware and Software

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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Step Action Expected Result Observed Result Pass/Fail By/Date

4 Click the Wizard button located on

right side of the Query tab.

Record the software version for

PDM Pooling Wizard software.

The PDM Pooling Wizard main screen is

displayed. The software version is

displayed in the title bar.

PDM Pooling Wizard software version:

__________________________________

Pass Fail

________

5 Click Exit.

The PDM Pooling Wizard application

closes. The PDM Pooling Manager Query

tab is displayed.

Pass Fail

________

6 Click the Logoff button located on

right side of the Query tab.

The logoff is successful and a prompt is

displayed to press CTRL, ALT, DEL to

logon.

Pass Fail

________

Results

Acceptable ________ Unacceptable _________

Comments ________________________________________________________________________________________________________________

__________________________________________________________________________________________________________________________

Performed By _______________________________________ Date _________________

Verified By _______________________________________ Date _________________

Hamilton Microlab STAR IVD / STARlet IVD Pipettor and Roche PDM Pooling Manager Software Validation

Installation Qualification (IQ) Test Case HIQ-02: Location Verification

cobas s system 201 Validation Guide for Small Pools 10/2009, Revision 2.0

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Test Case HIQ-02: Location Verification

Purpose

This test case verifies proper positioning of the Hamilton Microlab STAR IVD / STARlet IVD Pipettor.

Prerequisites

None.

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

Action Expected Result Observed Result Pass/Fail By/Date

1

Examine the front and sides of the

Hamilton Microlab STAR IVD /

STARlet IVD Pipettor.

Personnel have access at the front and

sides of the instrument, for operation,

maintenance, and opening of the

protective covers.

Pass Fail

________

2

Examine the rear of the Hamilton

Microlab STAR IVD / STARlet IVD

Pipettor.

There is sufficient space for ventilation. Pass Fail

________

3

Examine the Hamilton Microlab

STAR IVD / STARlet IVD Pipettor

location.

The Hamilton Microlab STAR IVD /

STARlet IVD Pipettor is positioned away

from:

• heating ducts

• air conditioning vents

• direct sunlight

• intense artificial light

• laboratory equipment that emits

electromagnetic RF fields (e.g., X-ray

machine, elevator)

Pass Fail

________

Note: There are no special location requirements for the Pooling Management Workstation. The USB cable length limits its proximity to the instrument.

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