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Whitepaper: 21 CFR Part 11 Compatible Software for NucleoCounter® NC-3000™

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Is your data secure? In this whitepaper, you will learn how to maintain compliance with the FDA’s 21 CFR Part 11 regulation using the NucleoCounter® NC-3000™ system. This comprehensive guide explains each part of the regulation and outlines specific actions you can take as an NC-3000™ user to ensure compliance.

This whitepaper also details how the NC-3000™’s software, NucleoView™ NC-3000™, is designed to simplify compliance. We provide examples of the Audit Trail, which tracks all activities recorded by the software, ensuring complete traceability. Learn about the different user levels and how the instrument ensures data integrity and security.

With this whitepaper and our user guide, you will gain a solid understanding of 21 CFR Part 11 and learn what is required to build a compliant cell analysis system in your production facility.

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