This guidance is intended to describe the Food and Drug Administration’s (FDA’s) currentthinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
These requirements include, for example, certain provisions of the Current Good Manufacturing Practice regulations (21 CFR Part 211), the Quality System regulation (21 CFR Part 820), and the Good Laboratory Practicefor Nonclinical Laboratory Studies regulations (21 CFR Part 58)
The development of the rule was initiated around 1990 by the US Pharmaceutical Manufacturing Association (PMA, now Pharmaceutical Research and Manufacturing Association, PhRMA). Shortly after that the PMA and also the US Parental Drug Association (PDA) formed technical groups to address the subject. Industry representatives met many times with the FDA’s task force under Paul J. Motise to determine how to accommodate paperless record systems under the current Good Manufacturing Practice (cGMP) regulations. The task force recommended publication of an “Advanced Notice of Proposed Rulemaking” (ANPRM) to obtain public comments on the issues involved.