eBook - PDF
Validating Pharmaceutical Systems
Good Computer Practice in Life Science Manufacturing
- 576 pages
- English
- PDF
- Available on iOS & Android
eBook - PDF
About this book
All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners
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Yes, you can access Validating Pharmaceutical Systems by John Andrews in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.
Information
Table of contents
- Front Cover
- Contents
- The Editor and His Contributors
- Foreword
- Editor's Introduction
- Chapter 1: Considerations for Computerized System Validation in the 21st Century Life Sciences Sector
- Chapter 2: An Inspector's Viewpoint
- Chapter 3: State-of-the-Art Risk Assessment and Management
- Chapter 4: Validation Planning and Reporting
- Chapter 5: Supplier Audits: Question and Answers
- Chapter 6: Developing Good Specifications
- Chapter 7: Traceability of Requirements Throughout the Life Cycle
- Chapter 8: Good Documentation in Practice
- Chapter 9: Good Testing Practice: Part 1
- Chapter 10: Enterprise Resource Planning Systems — Aligning Business and Validation Requirements
- Chapter 11: Calibration in Practice
- Chapter 12: Validating Legacy Systems
- Chapter 13: Technology Transfer Keys
- Chapter 14: Qualifying SCADA Systems in Practice Acquisition
- Chapter 15: The Application of GAMP 4 Guidelines to Computer Systems Found in GLP Regulated Areas
- Chapter 16: The Validation of a LIMS System — A Case Study
- Chapter 17: Compliance and Validation in Central and Eastern Europe (CEE)
- Chapter 18: Distribution Management Validation in Practice
- Chapter 19: Good Testing Practice: Part 2
- Chapter 20: Practical Applications of GAMP Version 4
- Chapter 21: Glossary and Abbreviations
- Index