Applied Physics · Precision technologies since 1992
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How to Maintain 21 CFR Part 11 Compliance with R100 Controllers

Microbial air sampling data supports product release decisions in pharmaceutical and biotech cleanrooms. When that data lives in electronic form, FDA 21 CFR Part 11 applies. The R100 Controller is built for remote sampling in critical ISO 5 zones and includes controls to help protect sample records. This guide explains what Part 11 requires and […]

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