GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 210/211 - Electronic Records with Drug GMPs

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The GMP Parts 11 Electronic Records; Electronic Signatures along with the Drug GMPs Parts 210 and 211 Current Good Manufacturing Practice for Finished Pharmaceuticals regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.

  • 21 CFR Part 11 Electronic Records; Electronic Signatures
  • Part 11 Scope and Application - August 2003
  • 21 CFR Parts 210/211 Drug GMPs

GMP Publications Quality Compliance Publications Helping Companies Meet and Exceed FDA and Total Quality Management Standards.

This is a great training and information tool to provide all employees with the CFR requirements for the Food, Drug, Medical Device, Cosmetic, Healthcare, Electronic Records and Good Laboratory Practice.













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GMP QMS 101 The Basics - The required GMP Training for all employees who operate under Title 21 Compliance Requirements.

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21 CFR Part 11 Electronic Records

  • 21 CFR Part 11 Basic Overview
    • 21 CFR Part 11 Definitions, System Types and Classifications
    • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
    • Part 11.10 Sections a) - k)
    - - Validation
    - - Copies of records
    - - Protection of records
    - - Limiting system access
    - - Audit trails
    - - Operational system checks
    - - Authority checks (h) Device checks
    - - Education, Training, Experience
    - - Policies and Procedures
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    • Scope and Application Risk Analysis - Determine Which Systems Need to be Validated
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