Unlike the U.S. Food and Drug Administration, European Health Authorities do not have a single document that defines the authorities‟ position on electronic records and electronic signatures. That is, there is no single document that is the equivalent of Code of Federal Regulations, Title 21 - Food and Drugs, Part 11 - Electronic Records; Electronic Signatures.
NextDocs has been asked to provide a response to specific regulations that cover aspects of electronic records and electronic signatures. This paper provides a response to the requirements of four specific regulations.
Please use the following web link to read or download the white Paper: NextDocs Corporation: NextDocs Compliance with Key European Regulations
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