21 CFR 11 (FDA)

The US FDA’s 21 CFR part 11 regulations provide criteria for acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. More information from the FDA’s website can be found here.

In the context of double seam inspection, if a can filler wants to use electronic records only instead of printing and signing all seam reports, it is important to verify that the system used complies with all 21 CFR part 11 regulations.