Live Webinar, September 25
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.
Gerhard Krüger is a Senior Consultant for Helix ALM. He has been helping customers and doing ALM implementations around the globe since 2004. An Agile Scrum Master and Cisco Certified Network Professional, he is also the architect responsible for Helix ALM in the cloud.