The Role Of FDA Predicate Rules In 21 CFR Part 11 Compliance

By James Jardine

In an era where digitization has become so central to our everyday lives, it’s hard for some to believe that there was a time digitized records were considered less trustworthy than paper documents. It was only 25 years ago that the 21 CFR Part 11 regulation established that electronic records and signatures maintained for regulatory purposes are as valid as paper records and handwritten signatures. By permitting the use of electronic record-keeping systems for maintaining records and submitting information to regulators, 21 CFR Part 11 builds upon the previously established regulatory requirements that applied to paper-based systems, also known as U.S. Food and Drug Administration (FDA) predicate rules.