Interpretation Blues? FDA Releases Draft Guidance On 21CFR Part11

Pharmaceutical Technology Europe magazine recently published an article of interest to those in the life sciences industry entitled The End of the 21 CFR Part 11 Controversy and Confusion?. The article outlines new draft guidance, issued by the U.S. Food and Drug Administration, on the intended scope and application of 21 CFR Part 11. Authored by Gordon B. Richmond, the article examines the confusion the regulation has caused in the pharmaceutical industry, and discusses the issues raised by the new draft guidance.

Richmond’s article concludes: “FDA’s recent draft guidance raises a number of new fundamental questions, and sets the stage for more controversy and confusion regarding Part 11 and how it will be interpreted and enforced. Given this reality, one thing seems clear - there is more collaborative work to be done if FDA and the pharmaceutical industry are going to succeed in reducing their respective compliance and enforcement burdens. “

21 CFR Part 11 is a U.S. Food and Drug Administration (FDA) regulation that provides criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.

For additional information see Title 21 Code of Federal Regulations (21 CFR Part 11) Electronic Records; Electronic Signatures.