chapter  22
26 Pages

Living with 21 CFR Part 11 Compliance

WithRichard L. Burcham

Introduction This chapter provides to manufacturers, contract research organizations (CROs), data management centers, clinical investigators, and institutional review boards, recommendations regarding the use of computerized systems in regulated industries. The computerized system applies to records in electronic form that are used to create, modify, maintain, archive, retrieve, or transmit data required to be maintained or submitted to the FDA.