Question: Provides some exposure to how regulatory compliance functions as a key element of IT governance.
Session Long Project
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
FDA
ISO
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?
Write a 2- to 3-page double-spaced paper.
Remember that these SLP papers require that you integrate, discuss, cite, and later fully reference at least three academically relevant sources. Use enough concurrent discussion so that the purpose of each citation is apparent. (Note that the paper is incomplete without at least three academically relevant references. Articles such as those in CIO and HBR are acceptable. You may also use military/corporate references, but they do not count as one of the required references.)
Use information from the modular background readings as well as any quality resource you can find. Please cite all sources and provide a reference list at the end of your paper.
Demonstrate an understanding of regulations and their impact on IT governance.
Demonstrate an understanding of risk for non-compliance.
Provide some in-text references to modular background readings.
Note: You are not to use any government/military classified or corporate-sensitive information in the development of any TUI papers or in any Discussions.
Length: Follow the number of pages required in the assignment excluding cover page and references. Each page should have about 300 words.