21 CFR PART 11 COMPLIANCE CHECKLIST

Achieve FDA 21 CFR Part 11-compliant
temperature monitoring in 9 steps

(without overcomplicating your processes)

FDA 21 CFR part 11 compliance checklist

If you work with temperature monitoring in Pharma or Biotech, you’re likely no strangers to the FDA’s 21 CFR Part 11 standard. 

Whether it feels like an uninvited guest who won’t leave your regulatory party or a welcome friend helping you secure the quality of your products, complying with the standard can be a tangled task.

We’re here to untangle it for you!

Explore the 9 steps you need to take to ensure your temperature monitoring practice is 21 CFR Part 11-compliant

The checklist is your guide to:

  1. Assessing your existing temperature monitoring procedures for compliance gaps.
  2. Establishing robust data integrity practices that impress regulatory auditors.
  3. Mitigating the risk of penalties and protecting your hard-earned reputation.
FDA 21 CFR part 11 compliance checklist

Security measures

Audit trails

Compliant signatures

Ready to simplify compliance and say goodbye to sleepless nights before audits?

The calibration of the Eupry temperature loggers is both easy and quickly done.

Kasper H. Christophersen

Research Associate at Novozymes

“Eupry saves us more than 500 working hours yearly, allowing us to use that time for other important tasks.

Dora Adanic

Chief Operating Officer at Genera Research

“I have nothing but praise for Eupry. They have invented a system, that is simple and does everything it promises.

Elvis Bergue

GDP Responsible Person at Worldwide Flight Service

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Get the

FDA 21 CFR Part 11

checklist

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