Status: Final
Date: September 3, 2003
Target Audience: Healthcare industry and regulatory publishing professionals
Laws and Regulations:
  1. 21 CFR Part 11, Electronic records and electronic signatures regulation
  2. 21 CFR Part 58, Good Laboratory Practice for nonclinical laboratory studies regulation
  3. 21 CFR Part 211, Good Manufacturing Practice regulation
  4. 21 CFR Part 820, Quality system regulation
Unlike the Food and Drug Administration’s (FDA) Guidances for Industry, “Providing Regulatory Submissions in Electronic Format – General Considerations,” and “Providing Regulatory Submissions in Electronic Format – Receipt Date,” the subject of this guidance is specifically the scope of electronic records regulation of record-keeping practices and electronic signatures. It emphasizes the need for being compliant with procedures for record copying, validation, record retention, and audit trail design in accordance with part 11 of Title 21 of the Code of Federal Regulations (21 CFR part 11).
The FDA warns that in fulfillment of 21 CFR part 11, companies should guard against unecessary measures in electronic submission development. The vast language of part 11 can lead a company into misinterpretation of the record-keeping process recommended for an electronic submission. If part 11 is incorrectly applied by a regulatory department to an electronic submission process, then the company could incur higher cost and lost time.
Recognizing that the subject matter of 21 CFR part 11 is too open to wide-ranging interpretation, this guidance aims to better focus what exactly this part 11 information means to the healthcare industry. Within the industry, the FDA is specifically targeting the individuals responsible for publishing regulatory data to the FDA for review.
The key points for regulatory professionals to consider:
  1. By correct identification of data, reduce the amount of records that are subject to 21 CFR part 11, so that the regulation can be more narrow in focus
  2. For records that are subject to part 11, the FDA can enforce the regulation at its own discretion, but there is a “grandfather clause,” in which older pre-1997 records systems included in a review have some degree of flexibility due to the limitation of the record systems from that era
  3. FDA enforces all predicate rules and requirements
By narrowing the focus of 21 CFR part 11, the FDA is hoping to instill greater refinement of the overall process of electronic record handling, improved communication with regulatory professionals, and increased data integrity.
Resulting Recommendations:
Companies that are submitting regulatory documents to the FDA for review should follow this guidance to ensure a navigable audit trail and more accurate submission document record-keeping. This guidance should be utilized as a tool for better understanding of 21 CFR part 11 as it pertains to records, electronic signatures, records access and records control.
What the FDA expects of handlers, controllers, or publishers of electronic regulatory documents is better understood with this guidance. Researching an audit trail of all phases of document development is easier. The accuracy of the signature process of parties responsible for different documentation in a regulatory submission is improved. The broad scope of 21 CFR part 11 is narrowed to a level that is better applicable at the regulatory professional level of implementation.
For more information on this issue, contact the Kulkarni Law Firm.