Revision of an IT consultancy's project handbook

Software that is used in the pharmaceutical area (e.g. for the QA system, for support of the manufacturing process for devices and medicines) must be validated. Above all, measures providing quality assurance must be used here (e.g. the release of documents, special test procedures, etc.) that go beyond the "usual standard" of software development.  The basis for this is often the recommendations of the FDA, "The Food and Drug Administration", subordinate to the United States Department of Health and Human Services. The FDA is responsible for promoting and protecting public health in the USA. The FDA regulates and ensures the safety and effectiveness of human and animal medications, biological products, medical products, foodstuffs and devices emitting radiation. This applies to products manufactured in the USA as well as to imported products." Source: http://de.wikipedia.org/wiki/Food_and_Drug_Administration