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

05922151190-03

cobas s 201 system Validation Guide for Small Pools 2 09/2010, Revision 3.0

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cobas s 201 system Validation Guide for Small Pools 3 09/2010, Revision 3.0

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

Test Case HOQ-13: Resolution Pooling (Library Plates Disabled) ...................................................................... 119

Test Case HOQ-14: Repeat Pooling (Library Plates Enabled)............................................................................... 126

Test Case HOQ-15: Repeat Pooling (Library Plates Disabled) ............................................................................. 133

cobas s 201 system Validation Guide for Small Pools 4 09/2010, Revision 3.0

Test Case HOQ-16: Correcting S-tube Barcode Reading Errors ......................................................................... 139

Test Case HOQ-17: Aborting a Pooling Run ............................................................................................................... 148

Performance Qualification (PQ)..........................................................................................................153

Overview................................................................................................................................................................................... 153

Section 2: COBAS

®

AmpliPrep Instrument, Optional Docking Station, 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................................................................................................................... 167

Test Case APIQ-05: Environment Verification........................................................................................................... 169

Test Case APIQ-06: Connections and Accessories................................................................................................. 171

Test Case APIQ-07: Safety and Training ..................................................................................................................... 173

Test Case APIQ-08: Documentation ............................................................................................................................. 175

Test Case APIQ-09: Consumables................................................................................................................................. 176

Test Case APIQ-10: Configuration Settings ............................................................................................................... 177

Test Case APIQ-11: Security............................................................................................................................................ 180

Operational Qualification (OQ)............................................................................................................185

Overview................................................................................................................................................................................... 185

Materials................................................................................................................................................................................... 185

Documentation ...................................................................................................................................................................... 185

General Prerequisites .......................................................................................................................................................... 186

Dependencies ........................................................................................................................................................................ 187

Test Case APOQ-01: Loading Reagents....................................................................................................................... 188

Test Case APOQ-02: Loading Consumables............................................................................................................... 191

Test Case APOQ-03: Routine Sample Preparation Run .......................................................................................... 195

Test Case APOQ-04: Handling Loading Errors........................................................................................................... 204

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............................................................... 224

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

Performance Qualification (PQ)..........................................................................................................245

Overview................................................................................................................................................................................... 245

Section 3: COBAS

®

TaqMan

®

Analyzer and AMPLILINK Software Validation ..........................247

cobas s 201 system Validation Guide for Small Pools 5 09/2010, Revision 3.0

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.................................................................................................................. 255

Test Case TMIQ-04: Environment Verification .......................................................................................................... 257

Test Case TMIQ-05: Connections and Accessories ................................................................................................ 259

Test Case TMIQ-06: Safety and Training..................................................................................................................... 261

Test Case TMIQ-07: Documentation ............................................................................................................................ 263

Test Case TMIQ-08: Consumables ................................................................................................................................ 264

Test Case TMIQ-09: Configuration Settings............................................................................................................... 265

Test Case TMIQ-10: Security........................................................................................................................................... 268

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.................................................................................................. 289

Test Case TMOQ-05: Analyzing Resolution Pools..................................................................................................... 294

Test Case TMOQ-06: Analyzing Additional Batches................................................................................................ 298

Test Case TMOQ-07: Status Indicators, Logs, and Problem Reports.................................................................302

Performance Qualification (PQ)..........................................................................................................307

Overview................................................................................................................................................................................... 307

Section 4: Roche PDM Data Manager Software Validation..........................................................309

Traceability Matrix .................................................................................................................................310

Installation Qualification (IQ) ..............................................................................................................311

Overview................................................................................................................................................................................... 311

Test Case PIQ-01: Data Management Workstation and Software.....................................................................312

Test Case PIQ-02: Data Manager Communication.................................................................................................. 314

Test Case PIQ-03: PDM Server Hardware .................................................................................................................. 316

Test Case PIQ-04: Safety and Training ........................................................................................................................ 318

Test Case PIQ-05: Documentation ................................................................................................................................ 320

Test Case PIQ-06: Configuration Security................................................................................................................... 321

cobas s 201 system Validation Guide for Small Pools 6 09/2010, Revision 3.0

Operational Qualification (OQ)............................................................................................................327

Overview................................................................................................................................................................................... 327

Test Case POQ-01: Reviewing Results from Primary Pools of 6 .......................................................................... 330

Test Case POQ-02: Reviewing Results from Resolution Pools ............................................................................. 338

Test Case POQ-03: Reviewing Results from Primary Pools of 1 .......................................................................... 343

Test Case POQ-04: Reviewing Invalid Results............................................................................................................ 348

Test Case POQ-05: Defining UDECs.............................................................................................................................. 352

Performance Qualification (PQ)..........................................................................................................357

Overview................................................................................................................................................................................... 357

Appendix: The Validation Process ......................................................................................................361

Introduction............................................................................................................................................................................. 363

Defining User Requirements............................................................................................................................................. 364

Selecting the System ........................................................................................................................................................... 364

Analyzing Risk........................................................................................................................................................................ 365

Preparing a Validation Plan............................................................................................................................................... 366

Executing the Validation Plan........................................................................................................................................... 367

Specifying Corrective Action............................................................................................................................................. 368

Using a Waiver Report ........................................................................................................................................................ 368

Preparing the Validation Report ...................................................................................................................................... 368

Forms......................................................................................................................................................................................... 369

cobas s 201 system Validation Guide for Small Pools 7 09/2010, Revision 3.0

Preface

Revision History

Manual Version Date Action

1.0 August 2009 Original document.

2.0 October 2009 Addition of Configuration to Title Page

3.0 September 2010 Revision of HOQ-03 and HOQ-16.

Roche Diagnostics Ltd.

CH-6343 Rotkreuz

Switzerland

Distributed by

Roche Diagnostics

9115 Hague Road

Indianapolis, IN 46250-0457 USA

(For Technical Assistance call the

Roche Response Center

toll-free 1-800 526-1247)

Roche Diagnostics

2, Avenue du Vercors

38240 Meylan, France

Roche Diagnostics GmbH

Sandhofer Straße 116

68305 Mannheim, Germany

Distributore in Italia:

Roche Diagnostics S.p.A.

Viale G. B. Stucchi 110

20052 Monza, Milano, Italy

Roche Diagnostics, SL

Avda. Generalitat, 171-173

E-08174 Sant Cugat del Vallès

Barcelona, Spain

Distribuidor em Portugal:

Roche Sistemas de Diagnósticos Lda.

Estrada Nacional, 249-1

2720-413 Amadora, Portugal

Roche Diagnostics

201, boulevard Armand-Frappier

H7V 4A2 Laval, Québec, Canada

(For Technical Assistance call:

Pour toute assistance technique,

appeler le: 1-877 273-3433)

Roche Diagnostica Brasil Ltda.

Av. Engenheiro Billings, 1729

Jaguaré, Building 10

05321-010 São Paulo, SP Brazil

cobas s 201 system Validation Guide for Small Pools 8 09/2010, Revision 3.0

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 201 system Validation Guide for Small Pools 9 09/2010, Revision 3.0

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 201 system Validation Guide for Small Pools 10 09/2010, Revision 3.0

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 201 system Validation Guide for Small Pools 11 09/2010, Revision 3.0

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 201 system Validation Guide for Small Pools 12 09/2010, Revision 3.0

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 201 system Validation Guide for Small Pools 13 09/2010, Revision 3.0

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 201 system Validation Guide for Small Pools 14 09/2010, Revision 3.0

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 for Small Pools 15 09/2010, Revision 3.0

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 201 system Validation Guide for Small Pools 16 09/2010, Revision 3.0

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 201 system Validation Guide for Small Pools 17 09/2010, Revision 3.0

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 201 system Validation Guide for Small Pools 18 09/2010, Revision 3.0

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 201 system Validation Guide for Small Pools 19 09/2010, Revision 3.0

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 201 system Validation Guide for Small Pools 20 09/2010, Revision 3.0

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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