Zdrowie i gospodarka · 30/07/1999

Enforcement Policy: Electronic Records; Electronic Signatures Compliance Policy Guide; Guidance for FDA Personnel

The Food and Drug Administration (FDA) is announcing the availability of a new Compliance Policy Guide (CPG) section 160.850 entitled ``Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures.'' This CPG is intended to represent the agency's current thinking on how to comply with the regulations for electronic records and electronic signatures. It also provides that agency decisions on whether or not to pursue regulatory actions will be based on a case-by-case evaluation. The text of the CPG is included in this document. DATES: Written comments may be submitted at any time.