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2 pages/≈550 words
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APA
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Technology
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English (U.S.)
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Topic:

Key Element of IT Governance (Essay Sample)

Instructions:

After you review the videos, write a 2-3-page paper (please not 1 and a half, TWO FULL Pages or more please just like you did last time) 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 (FDA & ISO), as well as solutions that meet compliance requirements. This grid does NOT count toward the 3 pages assigned. It consist of 3 rows and 3 columns with the following info::: 
___________Regulation Risk of Non-Compliance Solutions to Compliance
FDA
ISO__________________
***Use information from the 8 background readings (listed below) as well as any quality resource you can find. Please cite all sources and provide a reference list at the end of your paper. YOU MUST 
1. Demonstrate an understanding of regulations and their impact on IT governance.
2. Demonstrate an understanding of risk for non-compliance.
3. Provide some in-text references to modular background readings.
FINALLY 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. Clearly in-depth Answer “Is it advisable to develop a compliance quality system in-house?”
________________****Begin with the website of the MasterControl Quality Management System http://www(dot)mastercontrol(dot)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.
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.)
***PLEASE NO PLAGIRISM. You wrote an OUTSTANDING paper the last time for me, which is why I am requesting you again. Please write a dynamic A+ paper like you did last time, the more info the better!!!**** I will have more in the future for you specially, Thank you!!! 
**These are the background readings/references to use:_____
#1.)Cantor, M., & Sanders, J. D. (2007, May 15). Operational IT governance. Retrieved from https://www(dot)ibm(dot)com/developerworks/rational/library/may07/cantor_sanders/
#2.)Zurich Help Point. (2010). The liability of technology companies for data breaches. Retrieved from https://www(dot)advisen(dot)com/downloads/Emerging_Cyber_Tech.pdf
#3.)Huhta, S. (2011). IT architecture for small & mid-sized organizations. Business Forum Journal. Retrieved from http://www(dot)bizforum(dot)org/Journal/www_journalSH002(dot)htm
#4.)SlideShare. (2009). IT infrastructure (Part I). [Power Point slides]. Retrieved from http://www(dot)slideshare(dot)net/soetam/1-mis-it-infrastructure-part-i
#5.)Schwartz, K. D. (2007, May 22). IT governance definitions and solutions. CIO. Retrieved February 15, 2011, from http://www(dot)cio(dot)com/article/111700/IT_Governance_Definition_and_Solutions
#6.)Musthaler, L., & Musthaler, B. (2008, March 26). IT governance best practices are critical for business success. NetworkWorld. Retrieved from http://www(dot)networkworld(dot)com/newsletters/2008/052608techexec1.html?page=1
#7.)Master Control Compliance Accelerated. (2011). Master Control Quality Management System. Master Control Resource Center. Retrieved from http://www(dot)mastercontrol(dot)com/resource/online_resources.html#od
#8.)Kadivar, S. (2011, February 15). Green memories accelerate ROI for data centers. CIO. Retrieved from http://www(dot)cio(dot)com/article/665167/Green_Memories_Accelerate_ROI_for_Data_Centers?taxonomyId=3028

source..
Content:

Exposure to How Regulatory Compliance Functions as a Key Element of IT Governance.Module3-SLP
Student Name
Instructor
Course
Date
The quality and reliability of a product is key to the consumer’s satisfaction. These usually depend on the conformance to lay down regulations or specifications by the concerned organizations. A particular concern is put on products that directly affect the public health and safety, for example, food and medicine. Due to these, the Food and Drug Administration (FDA) and ISO regulations have been put in place to protect the consumer and also enable the manufacturers evade lethal consequences that may result from poor quality and unsafe products they release to the market (Cantor, 2007). Some FDA and ISO regulations do require nonconformance disposition especially those products that do not conform to the set standards and specifications. Some of these regulations include:
ISO 14001:2004 which requires adherence and maintenance of the nonconformance management procedures.
FDA Quality System Regulation (QSR) that requires manufacturers of medical equipment establish and adhere to procedures that ensure the conformance of the products to the set specifications. Also, the disposition of the nonconforming products must be documented and filed.
ISO 13485:2003 that needs the inclusion of management reviews and the analysis of the data on product conformity.
In this digital era, IT governance is of primary concern due to the need to deliver more solutions to the current business systems by incorporating IT operations and investments. MasterControl Quality Management System helps in the sphere of IT governance by ensuring compliance (Accelerated, 2011). IT governance involves the establishment of reliable networks for responsibility and communication. MasterControl Quality and Management System is an online platform using an integrated approach to conformity. According to the FDA and ISO regulations, the quality of the product is key to its acceptability in the market. The set specifications for the softwares must be met. MasterControl tracks the quality of the softwares they introduce to the market by closely working with the client in its installation and maintenance (Huhta, 2011). The stronger link between the clients and MasterControl is enhanced by subsidiary services like validation and technical support. ISO specifications and the FDA regulations govern the organization’s process as MasterControl Inc. is concerned with the automation of quality processes and the compliance with the ISO and FDA regulations. Manufacturing organizations usually have means of participating in the governance processes, but there might be internal processes that are not explicitly required in the governance (Kadivar, 2011). These internal processes require careful analysis and governance to improve the overall performance of the organization. MasterControl Inc. provides software solutions that will govern these internal processes; through the use of integrated compliance, the performance of the client organization will be by the market standards or regulations.
IT avails more worth to the busin...
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