Frequently Asked Questions: FDA 21 CFR Part 11
What is 21 CFR Part 11?
21 CFR Part 11 is a U.S. Food and Drug Administration (FDA) regulation that outlines criteria for the use of electronic records and electronic signatures, as well as when they are “considered equivalent to paper records and handwritten signatures executed on paper.” The regulation’s intent is to ensure the integrity and security of electronic records and signatures.
Does 21 CFR Part 11 apply to my business?
Organizations that are regulated by the FDA or supply related products and/or services need to comply with 21 CFR Part 11. The most common of these industries include, pharmaceuticals, biotechnology, medical devices, clinical labs, food and beverage manufacturers, and cosmetic manufacturers.
How do I benefit from 21 CFR Part 11 compliance?
For FDA-regulated companies, 21 CFR Part 11 compliance is mandatory, but it should not be considered a burden.
The goal of 21 CFR Part 11 is to allow businesses to use digital technology while ensuring the integrity and security of electronic records. Companies gain multiple efficiencies by adopting digital technologies and automating record-keeping and approval processes. Benefits include reducing margin of error, speeding document routing and approval, creating an automatic audit trail with easy trackability and traceability, and minimizing the risk of using outdated documentation.
What are FDA 21 CFR Part 11 requirements?
FDA 21 CFR Part 11 has three subparts:
- General Provisions
- Electronic Records
- Electronic Signatures
General requirements in Subpart B cover:
- System validation
- Readable records
- Document storage and record retention
- System access controls
- Audit trails
- Workflows
- Authorized user checks
- Device checks
- Personnel qualifications
- Personnel accountability
- Document control
Requirements for Subpart C cover:
- Identity verification
- Security controls
- Use of logins and passwords
For more detailed information visit https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
How does QT9 QMS help with FDA CFR 21 Part 11 compliance?
With QT9 QMS, all of your document and record management is automated, including the ability to capture 21 CFR Part 11-compliant signatures. Our cloud-based platform makes electronic records and FDA-compliant signatures possible from any device, anywhere, at any time.
With more than 23 modules that come standard, QT9 QMS streamlines quality processes and regulatory compliance with powerful scalability and efficiency. We are a highly rated system, loved by customers. Reach out today for more information.
