Achieve 21 CFR Part 11 compliance

Upgrade to digital data logging and storage

FDA 21 CFR Part 11 Compliance

Regulatory agencies are now willing to accept paperless records but many producers in the food & beverage, pharmaceutical and biotech industries haven’t yet converted or even planned to transition to paperless solutions.

Robust record keeping is at the heart of FDA 21 CFR Part 11 compliance and while the regulation itself does not require users to maintain records electronically, the processing of data electronically has many advantages:

  • The utilization of the data by other systems: e.g. data viz applications, ERP systems, spreadsheets.
  • The retrieval and comparison of several recording periods (not just the last 12 hrs) to observe trends that might otherwise be overlooked between physical charts.
  • Elimination of paper handling and the need to manage, store, or maintain large numbers of paper records.
  • Clear and informative audit trails.
  • Data backups and redundancy fail-safes.
Define Instruments Cloud-based IIoT solutions provide a cost-effective way to store and harness your data digitally while complying with the FDA’s criteria.
21 CFR Part 11 Compliance

Still using paper-based data recording?

Cloud-based IIoT data recording is now more economic and more flexible than paper record keeping, and the network infrastructure required for data storage is significantly more accessible.

Additionally, compliance requirements such as restricted access for differing pay grades, password protection, digital signatures and data backups are all now easily available within Define’s IIoT solution.

It’s time to do away with your ageing paper system and upgrade to a modern, user-friendly IIoT solution – a solution which provides so much more than just the logging of data signals.

Need to comply with 21 CFR Part 11? Get in touch!

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