Yes…and no. Unfortunately, despite FDA’s intent to raise the enforcement profile of Part 11, no Warning Letters actually cite 21 CFR 11, only the predicate rules. That said, the agency is trying to make clear the responsibility of firms to comply with Part 11 rules for electronic information:
You are responsible for the accuracy and integrity of the data generated by your firm. Provide a more comprehensive corrective action plan to ensure the integrity of all data used to assess the quality and purity of all drugs manufactured at your facility, including any registration lots. (Warning Letter to Cadila Healthcare, June 2011)
Or this one:
You are responsible for the accuracy and integrity of the data generated by your firm. A firm must maintain all raw data generated during each test, including graphs, charts, and spectra from laboratory instrumentation. These records should be properly identified to demonstrate that each released batch was tested and met release specifications. Appropriate record retention policies should also be in place. … Should product quality or safety concerns arise in the future, the original records pertaining to batches listed in an application may be integral in providing reasonable assurances to the Agency regarding a product and integrity of data submitted to support it. (Warning Letter to Ningbo Smart Pharmaceutical Co., February 2011)
As should be clear from the above Warning Letter excerpts, FDA’s enforcement emphasis for Part 11 compliance is all about how companies ensure — or fail to ensure — record integrity (including, as in the Ningbo situation, appropriate FDA records and document retention).