Management of IT Governance Research Paper Example | Topics and Well Written Essays - 750 words

Management of IT Governance - Research Paper Example The ISO standards that apply globally cover a very wide range of consumer goods from manufactures. Anything that a particular manufacturer decides to do must have proper documentation of the whole process regarding non conformance disposition to show the justification of the action and the proper performance of the action. Compliance to FDA is mandatory for all manufactures in the life sciences and the other related industries. On the other hand, manufactures in the non-life sciences, though they comply with the various federal directives, they strictly adhere to the standards set by ISO. This can either be voluntary to enhance the reliability of their products or to comply with the requirements of the countries where they intend to sell their products. Among the directives enforced by FDA, the two, which have the most significant effect are the 21 CFR Part 820 ant the 21 CFR Part 211 that all require the application of a quality management process. 21 CFR Part 211 that is applicable to all pharmaceutical corporations, covers all aspects of development and manufacture of drugs, right from the personnel, the processes and to the distribution. Among the basic requirements of the regulation are records and reports. Pharmaceutical companies require quality management processes, which are compliant and efficient in order to maintain the required records and reports. The 21 CFR Part 820 that applies to companies dealing with medical devices, requires the presence of controls in the process of designing, documentation, manufacturing as well as production. It specifically requires the implementation of a quality management system that is appropriate for the particular medical device. FDA provides a definition of what it makes up a quality m anagement system and specifies the records, which the manufacturer of the medical device must maintain (Carpenter, 2014).