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By Tony Strattner

April 15, 2003 | The FDA has made a surprising announcement to suspend enforcement of some aspects of 21 CFR Part 11, regulations governing the submission of electronic records and signatures in place of paper records and handwritten signatures for the approval of new drugs and other products.

While drug and biotech companies must still comply with common good manufacturing practices (cGMP) regulations already in place for open and closed systems and electronic signatures, the agency does not plan to enforce Part 11’s validation, audit-trail, record-retention, and record-copying requirements. The FDA also won’t take regulatory action against legacy systems -- that is, computer systems operational before Part 11’s effective date of August 1997.

This moratorium will be lifted after the FDA issues final guidelines for Part 11 compliance later this year, including new directions for electronic audit trails as well as record retention and copying, and then holds public meetings this fall to decide whether to revise the regulation itself.

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), explains: “In the last five years, due to confusion over what’s included in the regulation and how to enforce it, that confusion was impeding the introduction of new technology. The rule had created the exact opposite of what was intended.”

However, Mark Heller, vice chair of the Government and Regulatory Affairs Department at Hale and Dorr LLP, in Washington, D.C., warns that, while the agency may be cutting back on its Part 11 enforcement plan, “firms aren’t getting carte blanche to ignore these regulations. Compliance problems identified in the past continue to serve as red flags to firms in the future.”

For full coverage of the FDA’s new policy shift, as well as strategies and tactics for Part 11 compliance, turn to our Strategic Insights Report on Regulatory Compliance.


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