5.7 Computerized Systems and Electronic Records

Electronic records are records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health      Service Act, even if such records are not identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.

For the most part, analytical electronic records are generated on computerized systems, including, but not limited to chem-stations associated with analytical equipment such as HPLCs, GCs, FTIRs, and UVs.  Computerized systems may also be connected to balances and other equipment where data is obtained. Computerized laboratory equipment should be evaluated during the inspection to determine if there is a data trail for the deletion and/or modification of data. The data trail should have a time and date stamp and indicate what was modified and what the modifications were. If the software was written by the firm's technical support group, review the validation records and the challenges the firm performed. Determine if there have been any changes to the system or software since validation.  If so, was a revalidation performed?

References:

• 21 CFR, part 11 Electronic Records/Electronic Signatures
• http://www.fda.gov/ora/inspect_ref/igs/gloss.html
• http://www.fda.gov/ora/inspect_ref/igs/csd.html

Electronic Records and Signatures regulations apply to any record in electronic form that was created, modified, maintained, archived, retrieved, or transmitted under agency records requirements. These regulations also apply to any electronic record submitted to the agency.