To successfully meet compliance demands, pharmaceutical manufacturers must develop, implement, and track the effectiveness of a company-wide compliance strategy. Key to that strategy is to adopt industry-specific enterprise software with functionality that supports Federal Drug Administration (FDA) requirements. Learn more about the criteria and recommendations you need to achieve compliance in the pharmaceutical industry.
creation of a new version of a document upon check in
captured data. In the creation of regulatory requirements around electronic data, the FDA defined an electronic record as any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, or distributed by a computer system. In 1997, the agency issued Part 11 of Title 21 of the Code of Federal Regulations (CFR) to ensure the security, traceability, and integrity of electronic records and electronic signatures.