Computer Validation Compliance takes a systematic Quality Assurance (QA) approach to computer validation in a regulated environment. Built on the authors' experiences at major multinational pharmaceutical companies, this book presents a complete, step-by-step guide covering the QA role from early development to final completion, from a compliance/regulatory perspective. Topics include responsibilities of the user, the developer, and QA, vendor assessment, contract facilities, end user computing, and implementing a quality assurance program. Appendices include useful computer system validation sample documentation, a case study, and checklists.
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Inside This Book
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First Sentence:
Within the past decade, there has been a proliferation of computer systems in the pharmaceutical industry that handle an enormous amount of critical data. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
hardware maintenance manual, computer validation program, computer validation process, raw data definition, dissolution calculations, device master record, developer contact, contract facility, vendor assessment, nonclinical laboratory study, quality assurance unit, device inspection, nonclinical laboratory studies, maintenance documents, developer groups, acceptance test plan, contract facilities, inspection guideline, parallel testing, validation status, assurance personnel, finished device, master disks, validation documentation, change control procedures Key Phrases - Capitalized Phrases (CAPs): (learn more)
Nine Points, Periodic Inspection Guidelines, Prospective Inspection Guidelines New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Within the past decade, there has been a proliferation of computer systems in the pharmaceutical industry that handle an enormous amount of critical data. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
hardware maintenance manual, computer validation program, computer validation process, raw data definition, dissolution calculations, device master record, developer contact, contract facility, vendor assessment, nonclinical laboratory study, quality assurance unit, device inspection, nonclinical laboratory studies, maintenance documents, developer groups, acceptance test plan, contract facilities, inspection guideline, parallel testing, validation status, assurance personnel, finished device, master disks, validation documentation, change control procedures Key Phrases - Capitalized Phrases (CAPs): (learn more)
Nine Points, Periodic Inspection Guidelines, Prospective Inspection Guidelines New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 73
books:
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14
books
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- A22.5 Flow Charts Video by Cengage Learning Delmar in Back Matter
- Pharmaceutical Marketing: A Practical Guide by Dimitris Dogramatzis in Back Matter
- Validation and Qualification in Analytical Laboratories by Ludwig Huber in Back Matter
- Electromagnetic Compatibility in Medical Equipment: A Guide for Designers and Installers by William D. Kimmel in Back Matter
- Isolation Technology: A Practical Guide by Tim Coles in Back Matter
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- Audit by Mail: Time and Cost Effective GMP Audit Tool by John Lyall in Back Matter
- International Clinical Trials: A Guidebook and Compendium of National Drug Laws, Two-Volume Set by Dominique Brunier in Back Matter
- Validation of Computerized Analytical Systems by Ludwig Huber on page 6
- Validation and Qualification in Analytical Laboratories by Ludwig Huber on page 290
- Clinical Data Management by Richard K. Rondel on page 141
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