FDA 21 CFR Part 11 Guidelines for Pharmaceuticals: References

Guidance for Industry FDA 21 CFR Part 11, Electronic Records; Electronic Signatures — Scope and Application


Food and Drug Administration References:

1. Glossary of Computerized System and Software Development Terminology (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA 1995) (http://www.fda.gov/ora/inspect_ref/igs/gloss.html)

2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 2002) (http://www.fda.gov/cdrh/comp/guidance/938.html)

3. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices (FDA, Center for Devices and Radiological Health, 1999)

4. Pharmaceutical CGMPs for the 21st 336 Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems Approach (FDA 2002) (http://www.fda.gov/oc/guidance/gmp.html)

Industry References:

1. The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (http://www.ispe.org/gamp/)

2. ISO/IEC 17799:2000 (BS 7799:2000) Information technology – Code of practice for information security management (ISO/IEC, 2000)

3. ISO 14971:2002 Medical Devices- Application of risk management to medical devices (ISO, 2001)

FDA 21 CFR Part 11 Guidelines for Pharmaceuticals: References:

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