Testing Computers Systems for FDA/MHRA Compliance: 1st Edition (Hardback) book cover

Testing Computers Systems for FDA/MHRA Compliance

1st Edition

By David Stokes

CRC Press

136 pages | 7 B/W Illus.

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Hardback: 9780849321634
pub: 2003-11-25
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pub: 2003-11-25
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Description

There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals manufacturing, testing to meet regulatory requirements adds an additional layer of complexity. Testing Computers Systems for FDA/MHRA Compliance focuses on software module, software integration, hardware, and system acceptance testing. Reflecting the renewed emphasis of the FDA and other global regulatory agencies towards systematic inspections and risk-based validation with an underlying scientific rationale, this guide focuses on current best practices in computer systems testing in the regulatory environment.

David Stokes demonstrates how the principles detailed in the GAMP 4 Guide can be used to define a pragmatic approach to testing. He includes techniques for testing large Internet-based systems for compliance with the stringent requirements of regulations such as 21CFR Part 11, and clarifies the relationship and responsibilities of the system "user" and "supplier". The author also delineates where testing starts in the project lifecycle, who performs what testing, where the lines of responsibility start and end, and the differences in the terminology used in the healthcare and general IT sectors. A checklist of questions to be used when developing System Test Specification(s), and templates for documenting typical system test results, round out the features that make this book a practical guide for all those involved in the development and implementation of IT systems for the pharmaceutical and related healthcare manufacturing industries. Senior managers, team project leaders, project team members, and industry trainees, will all benefit from this clear and practical guide.

Table of Contents

PURPOSE

SCOPE

What this Guideline Covers

When this Guideline is Applicable?

Who this Guideline is Intended for?

WHY DO WE TEST?

Because the Regulators Require Us to…

Because the Quality Assurance Department Require Us to…

Because We've Always Done it this Way…

Because it Saves Money!

WHAT TO TEST

GxP Priority

Software/Hardware Category

Test Rationale and Test Policies

Testing or Verification?

THE TEST STRATEGY

Risk Based Rationale

The Relationship Between Test Specification(s)

Integrating or Omitting the System test Specification(s)

The Role of Factory and Site Acceptance Tests

Roles and Responsibilities

Relationships with Other Lifecycle Phases and Documents (Inputs and Outputs)

THE DEVELOPMENT LIFECYCLE OF A TEST SPECIFICATION

Recommended Phasing; Interfaces Between and the Dependencies of Activities

Milestones in the Process

Inputs to the Development of a Test Specification

Document Evolution

Constraints on the Development of a Test Specification

Constraints on the Testing

Conducting the Tests

Outputs from the Testing

RECOMMENDED CONTENT FOR SYSTEM TEST SPECIFICATION(S)

Overview

General section

Individual Test Cases

GOOD TESTING PRACTICES

Prepare for Success

Common Problems

Testing in the Life Science Industries is Different

Prerequisite Training

An Overview of the Test Programme

Roles and Responsibilities

Managing a Test Programme

Checking Test Scripts in and out

Recording Test Results

To Sign or Not to Sign

The Use of Test Witnesses

Capturing Test Evidence (Raw Data)

Proceed or Abort? (Test Incident Management)

Categorising Test Incidents

Impact Assessment

Test Execution Status

Test Data Status

Test Log-On Accounts (User IDs)

SUPPLIER SYSTEM TEST REPORTS/QUALIFICATION

THE USE OF ELECTRONIC TEST MANAGEMENT AND AUTOMATED TEST TOOLS

The Need for Test Tools in the Pharmaceutical Industry

Test Tool Functionality

Electronic Records and Electronic Signature Compliance

The Availability of Suitable Test Tools

Test Script Lifecycle

Incident Lifecycle

Flexibility for Non-GxP Use

Project and Compliance Approach

Testing Test Tools

Test Record Integrity

Features to Look Out For

Appendix A - Hardware test specification and testing

Appendix B - Package Configuration Test Specifications and Testing

Appendix C - Software Module Test Specifications and Testing

Appendix D - Software Integration Test Specifications and Testing

Appendix E - System Acceptance Test Specifications and Testing

Appendix F - Risk Based Testing

Appendix G - Traceability Matrices

Appendix H - Test Script Templates

Appendix I - Checklists

Appendix J - References and Acknowledgements

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology