21 CFR Part 11 Overview
Trusted records, trusted signatures.
Overview · Version 1.3 · 4 pages
21 CFR Part 11 sets the conditions under which the FDA accepts electronic records and signatures in place of paper. This overview explains how MaxxLogix Outcome Cloud™ provides the technical controls Part 11 requires, for organizations managing records such as SOPs, quality records, deviations, and CAPAs. Outcome Cloud™ supports your Part 11 compliance; your organization validates it for its intended use.
Inside this document
- Built for regulated records and approvals: the technical controls for life sciences, pharma, biotech, medical device, and clinical organizations.
- Audit trails: secure and complete — who, when, and the old and new values for every change, read-only to everyone, including administrators, and exportable.
- Electronic signatures: locked to the record, showing the signer’s name, the date and time, and the meaning of the signature, with re-authentication at signing.
- Electronic records, control by control: how Outcome Cloud™ supports the record requirements of §11.10 and §11.30 — from system validation and record protection to limited system access and operational checks.
- Electronic signatures, control by control: how Outcome Cloud™ supports the signature requirements of §11.50 to §11.300, including unique user IDs and two-component signing.
- Validation support: run validation tests in test mode without touching production, with release notes and advance notice for every version, and expert help available.
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