Revised guidance

The release of Part 11 by the FDA was intended to permit the extensive use of electronic technology in a manner consistent with the FDA's need to protect public health. The result was a significant amount of discussion within the industry requiring the subsequent release of a compliance policy guide and draft guidance for the following: validation, glossary of terms, time stamps, maintenance of electronic records, and electronic copies of electronic records.

While the intent was to produce a wide use of technology, concerns about Part 11 developed within the industry to the point where the regulation was perceived as having the opposite effect (see ISPE White Paper for examples).

In February of 2003, the FDA issued draft Part 11 guidance with a final guidance following in August 2003. In this final guidance, the FDA presented the group's intention to limit the scope and application of Part 11. Specific industry concerns about Part 11 were noted in this final guidance:

• Unnecessarily restricts the use of electronic technology inconsistent with the regulations intent

• Can significantly increase the costs of compliance due to the Part 11 requirements

• Discourages innovation and technological advances without providing significant public health benefit

The revised guidance is intended by the FDA to address these industry concerns as the result of the original Part 11 regulation was the opposite of the intent. The emphasis within this revised guidance is clear:

• FDA is re-evaluating Part 11 as it applies to FDA regulated products

• Part 11 remains in effect

• The FDA will narrowly interpret the scope of Part 11

  • Fewer records will be subject to Part 11

  • Part 11 will apply to:

    • Records required to be maintained by predicate rules) that are in electronic format in place of paper

    • Records required to be maintained by predicate rule(s) that are in electronic format in addition to paper format and are relied upon to perform regulated activities

    • Records submitted to FDA under predicate rules

    • Electronic signatures that are the equivalent to handwritten signatures required by predicate rule (e.g. reviewed, approved, verified)

• Enforcement discretion will be used during the period of re-examination

  • FDA does not intend to take enforcement action to enforce compliance with the validation, audit trail, record retention, and record copying requirements of Part 11 as explained in the final guidance

  • Records must still be maintained or submitted consistent with the applicable predicate rules

• No requirements will be enforced for systems that were operational before August 20, 1997, the effective date of Part 11

The enforcement discretion is strictly limited to the Part 11 requirements but some of these aspects of a system may still apply to satisfy the predicate rules. Regarding the areas identified for enforcement discretion, Part 11 should be viewed as not adding to or increasing the regulatory requirements defined in other regulations. Part 11 does not remove or invalidate existing requirements defined in other regulations. For example, system validation is still required for some systems by 21 CFR 820.70(i).

As of March, 2023, the FDA added paragraph (p) to "Subpart A-General Provisions 11.1, Scope", to add a limitation on electronic records required relative to Subpart R Part 1.