Resource List - FDA Part 11 - Electronic Records and Signatures

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Updated May 7, 2021

So many links broke.

You can still learn more about Part 11 here:

Part 11, Electronic Records; Electronic Signatures - Scope and Application - Guidance for Industry | FDA.gov

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One big list of resources for The FDA Regulations on Part 11, Electronic Records and Electronic Signatures. Useful for getting up to speed, answering questions, and to prepare for classroom training.

1. GMP Training Package Manual and CD, The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... System Validation and Part 11, Covering FD
2. Agent GXP FDA Part 11 Guidebook: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... Trials and GCP (Good Clinical Practices)
3. Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
4. Pharmaceutical Computer Validation Introduction 5 Users: GMP (Good Manufacturing Practices) Training Introduction to Meet FDA Regulations in the Use of ... on Computer System Validation and Part 11
5. CFR Parts 210, 211 and 11 Pocket Guide
6. Pharmaceutical Computer Validation Introduction Manual and CD, GMP (Good Manufacturing Practices) Training Introduction To Meet FDA Regulations in the ... on Computer System Validation and Part 11
7. Successfully Validating ERP Systems (and other large, configurable applications)
8. Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)
9. Part 11 risk assessment 'not an alternative' to compliance with predicate rules.(Electronic records): An article from: Validation Times
10. Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
11. 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
12. Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry (1stbooks Library (Series).)
13. Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healt
14. Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

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