Reference Information For The Software Verification And Validation Process

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Reference Information for the Software Verification and Validation Process

Computing systems are employed in the health care environment in efforts to increase reliability of care and reduce costs. Software verification and validation (V&V) is an aid in determining that the software requirements are implemented correctly and completely and are traceable to system requirements. It helps to ensure that those system functions controlled by software are secure, reliable, and maintainable. Software V&V is conducted throughout the planning, development and maintenance of software systems, including knowledge based systems, and may assist in assuring appropriate reuse of software.
Pharmaceutical Computer Validation Introduction Guidebook

Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the head of computer systems at a pharmaceutical company has to prepare for an FDA inspection. You will learn about regulations, the personnel responsible for computer validation, how to accomplish validation, examples of regulatory problems, and so on. It is also relevant for the medical device, food, and cosmetic industries. 86 pages in the guide include a handy printout of several relevant FDA documents. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version.