Zdrowie i gospodarka · 05/09/2003

FDA Releases Guidance on Narrowing Scope of Part 11 Electronic Records and Signatures Requirements

The Food and Drug Administration (FDA) has announced the availability of a guidance document clarifying its interpretation of Part 11 electronic records and signatures, which applies to all FDA-regulated products, and will exercise enforcement discretion for certain requirements, particularly for systems operational before August 20, 1997.