Tudor B.

FDA 21 CFR Part 11 Compliance - BetterQA

ISO 13485 Certified

FDA 21 CFR Part 11 & EMA Annex 11 Compliance

Achieve regulatory compliance for your healthcare software in 4 weeks. Our AI-powered testing ensures your electronic records and signatures meet FDA and EMA requirements.

Start Compliance Assessment

Weeks to Compliance

90.8%

First-Pass Rate

100+

Systems Validated

15+

Years Experience

What We Validate

Comprehensive testing against all Part 11 and Annex 11 requirements.

Electronic Records Integrity

Validation that electronic records are accurate, complete, and protected from unauthorized modification.

Electronic Signatures

Testing that signatures are unique, linked to records, and include required signer information.

Audit Trail Completeness

Verification of secure, time-stamped audit trails for all record creation, modification, and deletion.

Access Control Verification

Testing of user authentication, authorization levels, and system access restrictions.

Data Backup & Recovery

Validation of backup procedures, data integrity during restore, and disaster recovery capabilities.

System Documentation

Review and validation of SOPs, validation protocols, and compliance documentation packages.

4-Week Compliance Process

A structured approach to achieving FDA and EMA compliance.

Week 1: Assessment

System analysis, gap identification, and validation plan development.

Week 2: IQ/OQ

Installation and operational qualification testing with documentation.

Week 3: PQ

Performance qualification with real-world scenarios and user acceptance.

Week 4: Delivery

Final documentation, validation summary report, and compliance package.

Our FDA/EMA Services

Complete validation and compliance support.

Gap Assessment

Analysis of your current system against Part 11/Annex 11 requirements with remediation roadmap.

IQ/OQ/PQ Testing

Full validation lifecycle from installation through performance qualification.

Documentation Package

Complete validation documentation ready for FDA/EMA inspection.

Ongoing Compliance

Periodic review, change control support, and revalidation services.

FDA Compliance FAQ

What systems require Part 11 compliance? +

Any computerized system that creates, modifies, maintains, archives, retrieves, or transmits electronic records in place of paper records, or uses electronic signatures, must comply with Part 11.

What's the difference between Part 11 and Annex 11? +

Part 11 is FDA's US regulation; Annex 11 is the EU/EMA equivalent. Both cover similar requirements for electronic records and signatures. We validate against both for global compliance.

How long does validation typically take? +

Our standard process is 4 weeks for most systems. Complex or legacy systems may require 6-8 weeks. We provide detailed timelines during the initial assessment.

What documentation do you provide? +

Complete validation package including: Validation Plan, IQ/OQ/PQ protocols and reports, traceability matrix, validation summary report, and all supporting evidence.

Do you support SaaS and cloud systems? +

Yes. We have extensive experience validating cloud-based systems, including vendor assessment, shared responsibility models, and appropriate qualification approaches for hosted solutions.

Ready for FDA Compliance?

Get your healthcare software validated in 4 weeks with our proven process.

Start Compliance Assessment