21 CFR Part 11 compliant monitoring and mapping in GxP
How to pass FDA inspections
How do you make sure your monitoring, mapping, and similar compliance processes are 21 CFR Part 11-compliant? Learn how to turn 21 CFR Part 11 into simple steps.
21 CFR Part 11 is the FDA's standard for electronic records and signatures in regulated environments – and highly relevant for GxP companies working in or with the US (yes, if you have any affiliation, it probably applies to you as well). Not complying with the standard can lead to anything from smaller non-conformities and CAPAs to audit failures and reputational damage.
But what are the requirements of 21 CFR Part 11? And how do you turn them into actionable steps you can implement in your thermal compliance procedures?
Watch the step-by-step guide to keeping your processes and records up to standard – without overcomplicating your procedures.
Key takeaways
- What are the actual requirements of 21 CFR Part 11?
- Which records fall under 21 CFR Part 11?
- How do you turn the requirements into concrete processes?
- Can technology help – and if so, how?
About the speakers
- Jakob Konradsen, Chief Quality Officer, Eupry: Jakob is a co-founder of Eupry and leads its quality and compliance strategy. With deep expertise in GxP validation, he has guided hundreds of companies in harmonizing temperature compliance across facilities and global operations.
- Anders Buchmann, VP Commercial, Eupry: Anders works closely with pharma and logistics companies worldwide to optimize validation and compliance processes. He brings real-world insight from these organizations and the operational impact of standardizing validation frameworks across sites.
And earn a certificate for your participation.
Stay up to date on upcoming webinars
Get informed about new webinars, workshops, and similar resources directly in your inbox.
Download the 21 CFR Part 11 checklist
Get a 9-step checklist to make sure your mapping and monitoring are FDA 21 CFR Part 11 compliant.
Read the guide to 21 CFR Part 11
Dive into the guidelines for maintaining temperature records, systems, and processes that meet 21 CFR Part 11 requirements.