MasterControl Quality Management System
Begin with the website of the MasterControl 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 company-wide processes for regulation compliance. Review the 3-minute FDA and ISO videos to get familiar with non-compliance 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.
Then create a grid as shown below with the selected regulations and the risk of non-compliance for each regulation, as well as solutions that meet compliance requirements.
Regulation Risk of Non-Compliance Solutions to Compliance
Conclude with a summary of what you have learned in the demos and the advantages of implementing an enterprise-wide quality management system to establish IT governance. Is it advisable to develop a compliance quality system in-house?