21 CFR Part 11 Electronic Record Keeping Issues

IEH staff can assist pharmaceutical and food manufacturers with implementing electronic recording keeping systems following the requirements in the 21 CFR Part 11 regulation and the FDA Part 11 Guidance Document. IEH continuously monitors developments within FDA regarding electronic records and electronic record generating systems, and IEH staff has worked with a number of manufacturers in evaluating and validating electronic record keeping systems.

Depending on client preferences and the client industry, IEH staff will follow a GAMP 4 or NFPA Bulletin 43-L validation protocol to ensure implementation of proper validation procedures for hardware and software for electronic record keeping systems used in the pharmaceutical and food processing industries. IEH can determine what client records fall under FDA predicate rules and need to meet Part 11 requirements, and IEH staff will ensure proper system validation documentation is in place at client facilities to support possible regulatory inspections of electronic record keeping systems.