The role of quality assurance in computer inspections.
Changing technology affords the Quality Assurance auditor with the challenge of applying computer validation concepts to a variety of computer system types. In addition, these technology changes have caused the developers role to change as well. In an innovative research facility, the developer may include an in-house professional group, a vendor, or an end-user. With these issues in mind, the QA auditor needs a tool to accomplish the task of inspecting systems as they are being created. The prospective inspection process is the tool for accomplishing this task. This inspection involves the QA auditor's involvement in the development of a new system, as a member of the development team, from the initial creation through the implementation of the computer system. This presentation will focus on illustrating the steps in conducting the prospective inspection process, from expected deliverables and document reviews to final report and management notification. The benefits of QA involvement in the development process will also be discussed.
Gauntlett
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Merck Research Laboratories, West Point, Pennsylvania 19486-0004.
D002984:Clinical Laboratory Information Systems / Q000592:standards*; D004282:Documentation; D008330:Management Audit / Q000379:methods*; D011446:Prospective Studies; D011786:Quality Control; D012985:Software Design; D012986:Software Validation