In the United States (US), GxP regulations are enforced by the FDA and are contained in Title 21 of the Code of Federal Regulations (21 CFR). Within 21 CFR, Part 11 contains the requirements for computer systems that create, modify, maintain, archive, retrieve, or distribute electronic records and electronic signatures in support of GxP-regulated activities. [...]
Yes. Trievr delivers proven regulatory compliance practices for document control and related training across the business. Delivering compliance with FDA 21 CFR Part 11 including Electronic Signatures and Audit Trail, SOP management, Policies, Procedures, Work Instructions, Manuals, Files and Reports will be created and controlled in compliance with global regulatory mandates. Trievr's request management solution is [...]