Validation
- Last UpdatedApr 12, 2023
- 1 minute read
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ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) |
This document is one guideline, used widely within FDA-regulated industries, for validation of computer systems. ISPE and the GAMP Forum produce the GAMP Guide. http://www.ispe.org/gamp/ |
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General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002) |
This guidance presents principles of software validation considered to be applicable by the FDA. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation |
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Current Good Manufacturing Practice (CGMP) Regulations November 16, 2022 |
This summary describes regulations in 21 CFR related to Part 11. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations |
FDA publications can be downloaded from the United States Food and Drug Administration web site at http://www.fda.gov/.
Guides developed by the International Society for Pharmaceutical Engineering (ISPE) can be purchased through ISPE at http://www.ispe.org/.