Navigating the New 21 CFR 11 Guidelines
March 01, 2004
When FDA commenced discussions on the use of electronic records in lieu of paper records in 1991, it embarked upon a six-year consultation exercise culminating in the issuance of the final rule "21 CFR 11,"1 which came into force on 20 August 1997. The final rule itself is succinct (approximately 2000 words), but has given rise to massive amounts of commentary and interpretative text. The latest guidance aims to address issues with these secondary texts rather than the rule itself.