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.