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Whitepaper: 21 CFR Part 11 Compatible Software for NucleoCounter® NC-200™

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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-200™ system. This comprehensive guide explains each part of the regulation and how users of the NC-200™ can take specific steps to ensure compliance.

The whitepaper also details how the NC-View™ software simplifies compliance. It provides examples of the Audit Trail, which tracks all activity recorded by the software, and explains the different user levels and how the instrument ensures data integrity.

With this whitepaper and the accompanying user guide, you will gain a solid understanding of 21 CFR Part 11 and what is required to establish a compliant cell counting system in your production facility.

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