21 CFR 11

Refers to Federal Drug Administration's "Title 21- Code of Federal Regulations-Part 11"

Manufacturers in industries regulated by the U.S. Food and Drug Administration (the “FDA”) are required to maintain and submit records associated with the products they manufacture. These records contain information about the product as well as hand written signatures of the individuals who executed the process and/or authorized the execution.

Historically, these records have been kept in paper format and submitted for review to the FDA upon request. As computer systems became readily accepted in the manufacturing environment, however, the storage of these records in electronic format was explored to see whether maintenance of these records in electronic format offered volume and cost benefits over the paper equivalent.

Early on, these studies raised questions about utilizing electronic media for storage of this information. Without the proper checks and balances in place, it could be possible to corrupt a record without maintaining the original data or being able to discern that the data had been modified. Additionally, the handwritten signatures that were used to authorize and execute the production were legally binding to the owners of the signatures. There was no equivalent for signatures executed electronically.

Following these studies, the FDA issued the 21 CFR Part 11 regulations on electronic signatures and electronic records in 1997, to establish the criteria under which electronic records and signatures would be considered equivalent to paper records and hand written signatures in FDA regulated industries.

The 21 CFR Part 11 regulation was in part intended to ensure that whenever manufacturers replaced traditional paper records with electronic records, they implemented the replacement systems in a manner that was equivalent to the paper based systems they were replacing. The regulation only applies where the records being maintained must be submitted for review to the FDA.