Under 21 CFR Part 11, FDA-regulated companies that choose to maintain electronic records to meet predicate rules are required to validate their electronic record-keeping systems. This is to ensure accuracy, reliability, and consistent intended performance of the system and to determine invalid or altered records.
Part 11 works in tandem with a predicate rule, which refers to any FDA regulation that requires organizations to maintain records. An example would be 21 CFR Part 820, which requires medical device manufacturers to maintain records pertaining to design history, quality system, complaint and complaint investigation, training, etc.
MasterControl Inc., a leading provider of quality management software solutions for companies in regulated environments, offers you the following “Good System Implementation Practice” tips that would help strengthen your validation documentation and help ensure Part 11 compliance.