21 CFR Brief History

Title 21, Code of Federal Regulations, Part 11, otherwise known as 21 CFR Part 11, is an FDA rule that defines parameters by which Pharmaceutical companies can author, approve, store, and distribute records electronically.

In 1991, members of the pharmaceutical industry met with the FDA to determine how the industry could accommodate paperless record systems under the current good manufacturing practice (CGMP) regulations in parts 210 and 211 (21 CFR parts 210 and 211).

The final rule, effective August 20th, 1997 with FDA enforcement starting January 2000, provides criteria under which FDA will consider electronic records to be equivalent to paper records, and electronic signatures equivalent to traditional handwritten signatures. 21 CFR part 11 applies to any paper records required by statute or agency regulations and supersedes any existing paper record requirements by providing that electronic records may be used in lieu of paper records. Electronic signatures which meet the requirements of the rule will be considered to be equivalent to full handwritten signatures, initials, and other general signings required by agency regulations.

FDA 21 CFR Part 11 enable the pharmaceutical industry and other FDA-regulated industries to streamline processes, reduce turnaround time and costs by establishing criteria for the use of electronic records and signatures; and with the help of DeltaTRAK 21 CFR Part 11 compliant software, time and cost reductions are realized with less effort and peace of mind. For companies that meet Part 11 compliance, electronic records and signatures can replace traditional paper records and signatures. The regulation outlines procedures and controls for ensuring the authenticity, integrity, non-repudiation and confidentiality of electronic records and signatures. Although Part 11 has been compared to Y2K for its potential impact on the industry, the regulation does not actually require companies to adopt electronic processes, but rather regulates those that are moving in the direction of a paperless environment. However, there is no “grandfathering” of legacy systems, which means that systems installed prior to August 20th, 1997 that create, modify, maintain, archive or retrieve electronic records required by the FDA for inspection and submission must be made compliant or replaced. When companies are not fully compliant with 21 CFR Part 11, the FDA makes a case-by-case evaluation as to whether or not to pursue regulatory actions. Non-compliance might lead to regulatory exposure, costly rework and downtime, compromised product quality, and even fines, prison sentences and sanctions.

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