Exposure to Regulatory Compliance (Essay Sample)

Exposure to How Regulatory Compliance Functions as a Key Element of IT Governance.Module3-SLP
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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 business operations through product innovation, client intimacy, and operational efficiency. An integration of two of these elements complicates the scope of IT governance (McCollum, 2004). Set standards have to be inculcated in product evaluation. The risk of unmet specifications or non-compliance is lethal and should be adopted by IT governance systems. Particular risk cases would encompass:
Legal Risks: Heavy fines may be assumed for non-compliance to the set specifications
Operational Risks: the daily operational costs will increase
Investment Risks: the amount of resources invested in that Process risk being lost or stagnating which is not desired in any organization (SlideShare., 2009).
Some of the risks mentioned above can be evaded by inculcating MasterControl Inc. in the Quality Management Systems. MasterControl Inc. identifies the goals of the client organization and bases the future decisions on these. Operational risks can be evaded by proper security management and efficient data integrity management process (Musthaler, 2008). Legal risks can be addressed by compliance with the ISO and FDA regulations that determine the authenticity of decisions executed by the company in the production or service delivery process (Point, 2010). Implementing an enterprise-wide quality management system to establish IT governance is advantageous to an organization because it:
Improves management of the related risks.
Improved value addition and delivery through the workflow improvements and the related business processes (Weill, 2004).
It is advisable to develop a compliance quality system in-house as it reduces the probabilities of conflicts emerging when responsibilities are not well-defined (Schwartz, 2011). It also encourages data sharing across the different departments that may be used to establish standard quality management systems.
RegulationRisk of Non-ComplianceSolutions to ComplianceFDA Quality System Regulation (QSR)
Public Health Risk: Electromagnetic radiation emitted by information technology equipment can impact negatively public health
Analysis of radiation-emitting devices and other technical aspects.
Enforcement of inspection seals for products to be released to the market.ISO
13485:2003Legal Risks: heavy fines imposed on the product
Investment Risk: Risk of withdrawal of the product from the market. Inclusion of management r...