21 CFR Part 11

Learn about 21CFR Part 11 requirements and find compliant solutions to data management.

Webinar: Tackling the 21CFR11 Challenge: From Paper to Paperless

Complying with the new 21 CFR Part 11 requirements present more challenging requirements. Bringing manufacturing processes and controls to a new level can appear simple in theory but provides many challenges in application. Using the example of a standard Data Management implementation, this presentation provides a variety of insights and solutions.

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Industries

Compliance

This video provides cleanroom environmental monitoring solutions for sampling, reporting, and data retention of particle, microbial and environmental data. The solutions focus on meeting 21 CFR Part 11 data integrity requirements resulting in efficient access to data, and eliminating human error.

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Data Integrity: Understand and Comply with GMP and FDA Requirements for 21 CFR Part 11

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21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions

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