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Newsletter Sponsor
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Compendial Water Testing and Data Integrity Challenges
TOC data and data integrity are critical components to successful and compliant cGMP processes. Currently many facilities fail to apply the same validation standards and protocols to software as instruments. Software is where the data are managed and stored and should have the same comprehensive validation standards applied. Like instruments, software has a set of specifications that describe how it functions and complies with regulations, for example 21 CFR Part 11. Software validation is fundamental to risk management and mitigation when it comes to data integrity.
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