The FDA just announced, FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs, that they will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance). The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the Guidance.
The guidance describes how FDA intends to exercise enforcement discretion and sets forth the following considerations related to Part 11:
- Part 11 remains in effect since the issuance of the guidance and the exercise of enforcement discretion applies as identified in the guidance.
- The guidance sets out certain conditions related to the validation, audit trail, record retention, record copying, and legacy systems where the Agency does not intend to take enforcement action to enforce compliance. Conversely, violations of part 11 requirements that do not fall within the guidance’s discretion can lead to enforcement action to enforce compliance depending on the importance of the violation.
- Records must also be maintained or submitted in accordance with regulatory requirements outside of Part 11, and we will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements.
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