WP-038
FDA 21 CFR Part 11 Compliance by Metrohm Raman
Summary
Norms and Standards 21 CFR Part 11 is the FDA rule relating to the use of electronic records and electronic signatures.
Recognizing the increasing impact of electronic media on critical data in regulated environments, the FDA met with members of the pharmaceutical industry in the early 1990s. The pharmaceutical industry and the FDA were interested in how they could accommodate paperless record systems and ensure the reliability, trustworthiness, and integrity of electronic records.