Application note: GxP regulated industry assessments of SoftMax Pro Software and microplate readers

Posted: 28 September 2021 | | No comments yet

Laboratories operating under GMP or GLP regulations must follow guidelines set by agencies to protect scientific integrity or demonstrate quality assurance of manufactured products.

21 CFR Part 11, 58, 211, and 820 and EudraLex Annex 11 and 15 provide rules and guidelines for the use of microplate readers and software in regulated environments. Labs operating under GMP or GLP regulations must follow these, and the impact of non-compliance can be high.

In these whitepapers, we provide an overview of the regulations and demonstrate how our SoftMax Pro GxP Data Acquisition and Analysis Software, and our microplate reader solutions, can help you achieve compliance.

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