EDMSNext for FDA 21 CFR Part 11 Compliance provides validated electronic records, electronic signatures, and immutable audit trails—helping regulated organisations meet FDA requirements with confidence.
EDMSNext for FDA 21 CFR Part 11 Compliance
EDMSNext for FDA 21 CFR Part 11 Compliance is designed for life sciences and regulated organisations that must maintain trustworthy electronic records and signatures. It enforces system controls, traceability, and accountability required by the FDA.
What Is FDA 21 CFR Part 11?
FDA 21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Compliance requires strict controls, validation, audit trails, and security.
Why 21 CFR Part 11 Compliance Matters
- Required for FDA-regulated electronic records and signatures
- Ensures data integrity and record authenticity
- Supports successful FDA audits and inspections
- Reduces regulatory and business risk
Core Part 11 Compliance Capabilities in EDMSNext
- Validated electronic records with controlled access
- Secure, compliant electronic signatures
- Computer-generated, time-stamped audit trails
- Role-based access and authentication controls
- Version control and record integrity enforcement
Who Needs FDA 21 CFR Part 11 Compliance?
- Pharmaceutical and biotech organisations
- Medical device manufacturers
- Clinical research and CROs
- Any FDA-regulated enterprise using electronic records
EDMSNext Controls for Part 11 Requirements
- Unique user identification and password policies
- Electronic signature manifestation and linking
- Record change tracking and reason-for-change capture
- System security and access monitoring
How EDMSNext Supports FDA Audits
EDMSNext provides inspectors with clear, chronological evidence of record creation, review, approval, and signature—without manual compilation. Audit trails are immutable and exportable on demand.
Manual Compliance vs EDMSNext
- Manual systems: Paper records, incomplete audit trails, inspection risk
- EDMSNext: Validated, electronic, and audit-ready compliance platform
Benefits of Using EDMSNext for Part 11
- Faster and smoother FDA inspections
- Improved data integrity and trust
- Reduced compliance overhead
- Scalable compliance across sites and systems
Next Steps for FDA Compliance
- Identify electronic records requiring Part 11 controls.
- Validate workflows, signatures, and audit trails.
- Implement a compliant electronic document platform.
Explore related EDMSNext capabilities: Features | Use Cases | Industries | Locations
Validate your FDA compliance readiness — book a demo or contact our team.
Follow EDMSNext regulatory and compliance insights on LinkedIn.
Frequently Asked Questions
What is FDA 21 CFR Part 11 compliance?
It is an FDA regulation that defines requirements for electronic records and electronic signatures used in regulated industries.
Does EDMSNext support electronic signatures under Part 11?
Yes. EDMSNext provides secure, compliant electronic signatures linked to records and users.
Are EDMSNext audit trails Part 11 compliant?
Yes. Audit trails are computer-generated, time-stamped, and immutable.
Is EDMSNext suitable for FDA inspections?
Yes. EDMSNext is designed to support FDA inspections with clear, exportable compliance evidence.
