RSC Chromatography Monographs
Validation of Chromatography Data Systems
Meeting Business and Regulatory Requirements
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DOI: 10.1039/9781847552297
Robert D McDowall (Author)
ISBN (online): 978-1-84755-229-7
ISBN (print): 978-0-85404-969-1
Copyright: 2005
Table of Contents
| Title | Page | |
 Front cover
DOI: 10.1039/9781847552297-FX001 (8Mb) |
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Front matter
DOI: 10.1039/9781847552297-FP001 (122Kb) |
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Preface
DOI: 10.1039/9781847552297-FP005 (60Kb) |
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Acknowledgements
DOI: 10.1039/9781847552297-FP006 (15Kb) |
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Contents
DOI: 10.1039/9781847552297-FP007 (611Kb) |
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List of figures
DOI: 10.1039/9781847552297-FP020 (116Kb) |
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List of tables
DOI: 10.1039/9781847552297-FP022 (82Kb) |
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Glossary
DOI: 10.1039/9781847552297-FP024 (149Kb) |
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Abbreviations
DOI: 10.1039/9781847552297-FP027 (119Kb) |
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How to use this book
DOI: 10.1039/9781847552297-00001 (447Kb) |
1 | Full Access |
| Introduction to chromatography data systems | 9 | License Access |
| Regulatory requirements for CDS validation | 19 | License Access |
| Concepts of computer validation | 33 | License Access |
| CDS validation: Managing system risk | 53 | License Access |
| Process redesign to exploit the tangible benefits of electronic signatures with a CDS | 61 | License Access |
| Writing the user requirements specification | 76 | License Access |
| Controlling the work: The validation plan | 87 | License Access |
| System selection | 96 | License Access |
| Auditing the CDS vendor | 102 | License Access |
| Contract, purchase order and planning the installation | 113 | License Access |
| Risk assessment and requirements traceability | 121 | License Access |
| Installation qualification and operational qualification | 127 | License Access |
| Performance qualification (PQ) or end-user testing | 136 | License Access |
| User training and system documentation | 159 | License Access |
| IT support of the system | 166 | License Access |
| System description | 177 | License Access |
| Validation summary report | 182 | License Access |
| Defining electronic records for a CDS | 188 | License Access |
| Maintaining the validation status during operational life | 199 | License Access |
| Periodic review of the CDS | 212 | License Access |
| Records retention | 218 | License Access |
| CDS data migration | 227 | License Access |
| CDS system retirement | 243 | License Access |
| Retrospective validation | 248 | License Access |
| References | License Access | |
| Subject index | License Access | |
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Back cover
DOI: 10.1039/9781847552297-BX003 (11Mb) |
Full Access |
