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.
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.
Application Note
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Application Note
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