Electronic records, signatures: Code of Federal Regulations will be discussed Sept. 22

Brief

Organizations required by the U.S. Food and Drug Administration (FDA) to keep or make reports are allowed to file or use electronic records and signatures. The Code of Federal Regulations, Title 21, Part 11 (21 CFR Part 11) establishes requirements for ensuring such electronic records and signatures are reliable.

The center's Research Trials Office is currently evaluating the center's approach to 21 CFR Part 11 and developing a set of recommendations for the future.

As a part of this project, key technical staff are invited to a presentation on "Part 11" on Wednesday, Sept. 22, 2-3:30 p.m. in Pelton Auditorium. Steven Weil, a senior security consultant with Seitel Leeds & Associates will lead the presentation. Refreshments will be served.

For more information, contact Anita Pang at 206-667-5187 or apang@fhcrc.org.

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