FDA - Impending 21 CFR Part 11 Inspections - Electronic Records

Get ready, here they come!

The FDA just announced, FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs, that they will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance). The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the Guidance.

The guidance describes how FDA intends to exercise enforcement discretion and sets forth the following considerations related to Part 11:

• Part 11 remains in effect since the issuance of the guidance and the exercise of enforcement discretion applies as identified in the guidance.
• The guidance sets out certain conditions related to the validation, audit trail, record retention, record copying, and legacy systems where the Agency does not intend to take enforcement action to enforce compliance. Conversely, violations of part 11 requirements that do not fall within the guidance’s discretion can lead to enforcement action to enforce compliance depending on the importance of the violation.
• Records must also be maintained or submitted in accordance with regulatory requirements outside of Part 11, and we will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements.

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Resource List - FDA Part 11 - Electronic Records and Signatures

• People also ask about FDA CGMP Online Training - recommended FDA GMP online training classes offered by SkillsPlus International Inc.

Updated July 1, 2025

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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