Managing Compliance to FDA21 CFR Part 11 – Electronic Records and Electronic Signatures

Managing Compliance to FDA21 CFR Part-11

Managing Compliance to FDA21 CFR Part-11 Does Kovair ALM Studio provide all of the required information to an organization to support 21 CFR Part 11 Compliance? Is Kovair ALM Studio an Open System or a Closed System? Part 11 of Title 21 of the Code of Federal Regulations applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in the Food and Drug Administration (FDA) regulations. Since the classic deployment of a Kovair Application Lifecycle Management system is a Closed System, this document will focus on the regulations only pertinent for such a system.