The intention of the 21 CFR Part 11 ruling is to ensure an unquestionable record of every change made during a product lifecycle. To meet this requirement, product development projects need repeatable procedures to track changes and signoffs. For medical device companies, that means two things:
- Meeting the FDA’s requirements for electronic signatures. They are not the same as digital signatures like those provided by Verisign, Entrust, or other commercial entities.
- End-to-end traceability to prove full compliance.
Compliance is only ever accomplished when the right people do the right things. This webinar will cover key points to meeting compliance, including:
- Secure access.
- Configurable workflow.
- Electronic signatures.
- Accurate change history.
- Trace reports.
Learn the necessities to 21 CFR Part 11, and see where software applications can create efficiency and confidence in your process.