Out of Specification (OOS) Software

OOS Software to Automate Out of Specification (OOS) Processes to Comply with FDA CGMPs and 21 CFR Part 211 and Part 820 Regulations

Good Manufacturing Practice (GMP) regulations require pharmaceutical, medical device and other regulated manufacturers to conform to approved specifications that define the parameters for a product to be considered safe. Many companies rely on out of specification software to help them investigate and resolve OOS incidents.

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