21 CFR 11 - Electronic Records with Scope & Application 21 CFR 11 - Electronic Records with Scope & Application and Part 11 Checklist 21 CFR 11 - Electronic Records with Scope & Application and Preambles 21 CFR 11 - with Scope & Application & Computerized Systems used in Clinical Investigation...
have become subject to part 11. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Fed...