Guidelines for FDA 21 CFR Part 11-compliant monitoring and mapping
Join us for a step-by-step guide to keeping your processes and records up to standard – WITHOUT overcomplicating your procedures.
9-step checklist for 21 CFR Part 11-compliant temperature monitoring
Explore the steps you need to take to ensure your monitoring procedures are 21 CFR Part 11-compliant.
Do you feel fully confident navigating the FDA’s 21 CFR Part 11 for your monitoring, mapping, and similar compliance practices?
21 CFR part 11 is somewhat of a holy compliance grail for any regulated company 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.
Join Eupry’s Chief Quality Officer Jakob Konradsen and co-founder and CCO Adam Hartmann-Kruckow as they go through everything you need to know to keep your temperature monitoring and mapping processes up to standard.
Key takeaways
- Which records fall under 21 CFR Part 11?
- What are the actual requirements of 21 CFR Part 11 (for your audit trails, security procedures, etc.)?
- How do you turn the requirements into concrete processes ensuring your operation lives up to the standard?
- How can technology help?
Adam Hartmann-Kruckow ,Co-founder & CCO at Eupry
Jakob Konradsen,Co-founder & Chief Quality Officer at Eupry
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Client Testimonials
“The calibration of the Eupry temperature loggers is easy and quick. I received a box with the new sensors (…) It took me under an hour to calibrate 40 loggers – including the time it took to find the refrigerators.”
Kasper H. Christophersen
Research Associate at Novozymes
“Automated temperature monitoring allows us to relax knowing that the temperature is automatically recorded, giving us reliable alarms if temperature deviation occurs.”
Dora Adanic
Chief Operating Officer at Genera Research
“The Eupry data loggers were easy and convenient to set up, the flexibility of the system offers the possibility to be aware of any change whenever there is a problem, and more importantly, the archives which hold all data in the cloud can be achieved at all times.”
Elvis Bergue
Electromechanical and Water Manager at Axonova
