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IT Governance: Compliance

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Write a 2- to 3-page double-spaced paper.

Length: Follow the number of pages required in the assignment excluding cover page and references. Each page should have about 300 words.

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Solution Summary

This posting gives you a step-by-step explanation of how software can help compliance with FDA and ISO standards. The response also contains the sources used.

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Step 1
There are several FDA and ISO regulations that protect consumers. The Food and Drug Administration is responsible for protecting the consumers through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription drugs, over the counter drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation, cosmetics, animal foods & feed, and veterinary products. The FDA enforces the Federal Food, Drug, and Cosmetic Act, Section 361 of the Public Health Service Act, and regulations related to other products. These products include condoms, lasers, and cellular phones (a). In addition, there is control of disease on products ranging from household pets, and sperm donation for assisted reproduction. To protect consumers, FDA regulates more than $1 trillion of consumer goods in the US. Of these $466 billion is in food sales, $275 billon in drugs, $60 billion in cosmetics, and $18 billion in vitamin supplements. The FDA programs for safety regulation vary by the type of product, its risks, and the regulatory powers given to the agency. There are some products for which every aspect of the product is regulated. In case of prescription drugs, the testing, making, labeling, advertising, marketing, efficacy, and safety of the drugs is regulated by the FDA. In case of cosmetics, the FDA regulation relates mainly to labeling and safety aspects (b) . The FDA has published standards in every field and these are enforced through facility inspections.

Step 2
The ISO regulations that exist for protecting the ...

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