Director of Sales Execution
How Harmonizing 21 CFR Part 11 and Data Integrity Delivers Higher Quality Products by David Jensen, Staff Writer, MasterControl
Q: Remind us what 21 CFR Part 11 is.
Matt: In a nutshell, Part 11 states that electronic records and electronic signatures are equivalent to their paper record and handwritten signature counterparts. Per the FDA, the intent of the regulation is to permit the widest possible use of electronic technology for records management and signature processes.
Beneath that, there are controls that apply to electronic records, such as signature manifestations, which is information that links signers to their specific electronic signature. The regulation has guidelines on employing controls for ensuring the integrity of records in both open and closed systems. These include user authentication and accountability. Incidentally, these are among the most common Part 11 violations cited in warning letters. For example, a company might not have adequate system configurations that limit access and edit rights to only authorized individuals. Another issue involves multiple employees sharing the same login credentials.
Then, there’s the predicate rule, which requires companies to…” (Continue Reading Full Article)