ERES and Regulatory Overview.pptVIP

MBC Meeting - 21 November 2002 ERES and Regulatory Overview Karen M. Nichols, JD Genzyme Corporation ERES - 21 CFR Part 11 Some basics of electronic records; electronic signatures effective August 20, 1997 geared towards assuring data integrity of computerized systems used to meet predicate rule requirements enforcement is a “relatively recent” (since Y2K) phenomenon ERES - 21 CFR Part 11 Three sections Subpart A General Provisions Subpart B Electronic Records Subpart C Electronic Signatures ERES - 21 CFR Part 11 Scope Applies to: records in electronic form required under any pre-existing FDA regulation (aka “predicate rules” for GMPs, GLPs, GCPs) electronic records submitted to and subject to inspection by FDA hardware, software, documentation associated with both includes hybrid systems, electronic records that do not include an electronic signature there is no grandfather clause ERES - 21 CFR Part 11 ERES - 21 CFR Part 11 Definitions electronic record any combination of text, graphics, data, audio, pictorial, or other information…in digital form that is “created, modified, maintained, archived, retrieved or distributed by computer system” electronic signature A computer rendition (biometrics, non-biometrics, digital) of some unique ‘mark’ that an individual executes, adopts and authorizes that is considered to be a legally binding equivalent of a handwritten signature ERES - 21 CFR Part 11 Definitions open system an environment in which system access is not controlled by persons responsible for the content of the electronic records on the system closed system an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system ERES - 21 CFR Part 11 Definitions volatile (transient) vs nonvolatile data volatile data, though electronically gathered, is not memorialized on electronic media for future retrieval. Nonvolatile d