Company: Morton Grove Pharmaceuticals, Inc. Date:1/17/2017 Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Data Integrity Remediation Your quality system does not adequately ensure the accuracy and integrity of data to...Read More
This content is only available to Standards Navigator and Standards Navigators PLUS subscribers. See our Subscribe page for information on subscriptions. This document provides a summary of primary medical device standards as well as standards specific to Medical Device and Health IT software including Cybersecurity and systems and software engineering standards. It includes an assessment of how...Read More
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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.