Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements (Rsc Chromatography Monographs, 20, Band 20) - Hardcover

McDowall, Robert D.

Hardcover

ISBN 10: 1849736626 ISBN 13: 9781849736626

Verlag: Royal Society of Chemistry, 2016

Inhaltsangabe

Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate.

The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.

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Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate.

The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer s book shelf.

Aus dem Klappentext

Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate.

The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer s book shelf.

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Validation of Chromatography Data Systems

Ensuring Data Integrity, Meeting Business and Regulatory Requirements

By R. D. McDowall

The Royal Society of Chemistry

Copyright © 2017 R.D. McDowall,
All rights reserved.

ISBN: 978-1-84973-662-6

Contents

Chapter 1 How to Use this Book, 1, 
Chapter 2 What is a CDS? The Past, Present and Future, 22, 
Chapter 3 Laboratory Informatics and the Role of a CDS, 57, 
Chapter 4 Applicable GXP Regulations and Guidance for CSV, 74, 
Chapter 5 Concepts of Computer Validation, 147, 
Chapter 6 Understanding Software Categories and System Life Cycles, 167, 
Chapter 7 Ensuring Data Integrity for Chromatography Data Systems, 194, 
Chapter 8 CDS Validation: Managing System Risk, 266, 
Chapter 9 Working Electronically and Using Electronic Signatures, 284, 
Chapter 10 Writing the User and System Requirements, 303, 
Chapter 11 Controlling the Validation, 319, 
Chapter 12 System Selection, 333, 
Chapter 13 Assessing the CDS Supplier, 341, 
Chapter 14 Negotiating the Contract and Purchasing the System, 358, 
Chapter 15 Planning the Installation of the System, 364, 
Chapter 16 CSV Risk Management Requirements Level Assessment, 368, 
Chapter 17 Importance of the Traceability Matrix, 386, 
Chapter 18 Writing Configuration Specifications, 403, 
Chapter 19 Writing the Technical Specification, 412, 
Chapter 20 Installing and Integrating System Components, 418, 
Chapter 21 Designing the User Acceptance Test Suite, 431, 
Chapter 22 Writing Test Scripts and Test Cases, 447, 
Chapter 23 Executing Test Scripts and Reporting the Results, 472, 
Chapter 24 User Training and System Documentation, 484, 
Chapter 25 IT Support for a CDS, 513, 
Chapter 26 System Description, 532, 
Chapter 27 Defining Electronic Records and Raw Data for a CDS, 540, 
Chapter 28 Writing the Validation Summary Report, 562, 
Chapter 29 Integration in a Regulated Environment, 569, 
Chapter 30 User Account Management, 586, 
Chapter 31 Incident and Problem Management, 598, 
Chapter 32 Change Control and Configuration Management, 608, 
Chapter 33 Periodic Review of the CDS, 628, 
Chapter 34 CDS Records Retention, 657, 
Chapter 35 CDS System Retirement, 676, 
Chapter 36 CDS Data Migration, 682, 
Chapter 37 Retrospective Validation, 701, 
Glossary and Abbreviations, 708, 
Subject Index, 717, 

CHAPTER 1

How to Use this Book

This introduction provides an overview of how this book is structured and in which chapter to find information that you require. It also discusses why it takes so long to validate a chromatography data system and provides ten critical success factors that will help manage CDS validation projects.

1.1 Purpose and Scope

Chromatography is a major analytical technique that is used in almost all analytical laboratories in regulated healthcare organisations and contract manufacturing and research companies that support them. The days of chart recorders and paper and pencil interpretation have gone and today the chromatography data generated by a method is now acquired, stored, interpreted, manipulated and reported by a chromatography data system (CDS).

When a laboratory operates in a controlled industry, such as the pharmaceutical, biotechnology or medical device, along with the allied contract research or manufacturing organisations, the regulations require that the CDS be validated for its intended purpose according to applicable regulations. However, in today's world where many organisations work in a global market, there are many regulations from different regulatory authorities that are applicable even within a single laboratory.

The purpose of this book is to give readers a practical understanding of how to validate their CDS and to meet all regulatory requirements. The principles outlined here are applicable from small installations to large client server systems for a site and to larger terminal server systems operating between sites and over two or more time zones. The reader needs to scale the principles in this book to their specific system and ways of working.

Given the current regulatory interest in data integrity, the use of standalone CDS systems for GXP regulated work is not recommended and should be avoided. Furthermore, storing the regulated electronic records on standalone workstations is not recommended as they should be stored on a resilient network server and backed up by the IT department.

Chromatography Data Systems (CDS) are used throughout regulated laboratories in the pharmaceutical and allied industries. The role of a CDS in research and development and production (GMP) can be for determining the impurities of raw materials and finished products, in process control and stability testing, whilst in GLP development laboratories a system can be used for the measurement of a drug and their metabolites in biological fluids from non-clinical and clinical studies to determine the absorption, distribution, metabolism and excretion (ADME) of the compound. Regardless of the role of the regulated laboratory, there is a need to validate to show that the CDS, including LC-MS and LC-MS-MS data systems, are fit for their intended use as required by the applicable GLP or GMP regulations as well as 21 CFR 11 (electronic records; electronic signatures rule) and EU GMP Annex 11.

In this book, I want to discuss the prospective validation of chromatography data system software. By prospective validation, I mean validating the system properly and in advance of it being released for operational use. That is undertaking the validation work in parallel with progress through the life cycle of the project from start to finish and then releasing the system for operational use. Unfortunately, this is not always the case. Usually just before the system goes live someone thinks that perhaps we should validate the system! Taking this approach will add between 25-50% to the validation costs of the project. The main reason is documentation that should have been written at key stages of the project is missing or if written may not be of adequate quality for laboratories working under GXP regulations. However, some people may approach CDS validation retrospectively and in Chapter 37 there is an outline of what should be done in this situation. However, the main emphasis in this book is on prospective validation.

1.2 The Way It Was ...

In the past, the chromatograph and CDS software was purchased and then just before it was put into operational use and someone thought about validation of the system. Some common questions may have been:

• Have we validated the system? No.

• Does it matter? Probably.

• Will we get caught? Do not even think about answering no to this question.

• Data integrity? Do not worry – paper is our raw data.

Considering validation at such a late stage of the life cycle will mean a delay in going live, thus failing to gain benefit from the investment and releasing the system with no regulatory coverage. This depends on your approach to risk and if can you sleep at night.

This approach to validation had no concept or consideration of a system life cycle (SLC) or even testing the system to see if it was capable of supporting the laboratory.

1.3 The Way It Should Be ...

However, a proactive approach to validation is necessary. If done correctly validation will actually save...

Details zur Ausgabe

• Verlag: Royal Society of Chemistry
• Erscheinungsdatum: 2016
• Sprache: Englisch
• ISBN 10: 1849736626
• ISBN 13: 9781849736626
• Einband: Gebundene Ausgabe
• Auflage: 2
• Anzahl der Seiten: 733
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: preigu; mail@preigu.de; ; Lengericher Landstr. 19; Osnabrück; 49078; Deutschland