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FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs


The Agency (FDA) 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.


21 CFR 11 (Part 11) is the regulation that sets forth the criteria under which the Agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. This regulation, which applies to all FDA program areas, was intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health.

After Part 11 became effective in August 1997, significant discussions ensued among industry, contractors, and the Agency concerning the interpretation and implementation of the regulations. In response to Agency’s communications, some within industry raised concerns that interpretations of the Part 11 requirements could:

  1. Unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA's stated intent in issuing the rule.
  2. Significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted.
  3. Discourage innovation and technological advances without providing a significant public health benefit.

In an effort to address concerns that were raised, in August of 2003 the Agency published the ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ 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.

The Agency expects to begin conducting the Part 11 focused inspections soon.

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