FDA publishes new draft guidance for electronic signatures

The FDA has published a new draft guidance document describing its current thinking regarding the scope and application of 21 CFR Part 11 relating to electronic records and signatures. It says that it is planning to re-examine the regulation and may propose revisions as part of the initiative Pharmaceutical [C]GMPs for the 21st Century: A Risk-Based Approach. FDA is withdrawing its previous draft guidance documents in this area, as well as the Compliance Policy Guide CPG 7153.17.

In the meantime, FDA says it intends to interpret the scope of Part 11 narrowly, and to exercise discretion with respect to enforcing specific Part 11 provisions, namely the validation, audit trail, record retention, and record copying requirements. FDA also intends to exercise enforcement discretion with regard to systems that were operational before the effective date of Part 11.

Under the narrow interpretation, FDA considers Part 11 to be applicable to records that are required to be maintained by predicate rules, and the electronic format is used to perform regulated activities. Part 11 also applies to records submitted to FDA under the predicate rules, in electronic format; and to electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules.

Records must still be maintained or submitted in accordance with the underlying predicate rules, and regulated industry will continue to be responsible for maintaining and submitting secure and reliable records under predicate rules, and for meeting all other predicate rule requirements. FDA will enforce predicate rule requirements for records that remain subject to Part 11, and intends to enforce all other provisions of Part 11.

The FDA draft guidance document is available on-line.