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Master control quality paper
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Begin with the website of the Master Control Quality Management System http://www.mastercontrol.com/resource/online_resources.html#od
There you will find several demonstrations of how the MCQM system tracks quality while incorporating companywide processes for regulation compliance. Review the 3 minute FDA and ISO videos to get familiar with noncompliance risk, software validation, and risk assessment. You do not need to subscribe to the website, but make sure you think of yourself as a manager of IT governance in a big company rather than as a consumer.
After you review the videos, write a 2 to 3 page paper analyzing what you have learned. Start the paper with a brief overview and description of FDA and ISO regulations that exist to protect consumers. Briefly discuss how the MCQM system connects all processes critical to compliance.
