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质量保证在计算机检查中的作用。

The role of quality assurance in computer inspections.

作者信息

Gauntlett N

机构信息

Merck Research Laboratories, West Point, Pennsylvania 19486-0004.

出版信息

Qual Assur. 1994 Mar;3(1):27-32.

PMID:7804616
Abstract

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.

摘要

技术变革给质量保证审核员带来了将计算机验证概念应用于各种计算机系统类型的挑战。此外,这些技术变革也导致了开发者角色的变化。在一个创新的研究机构中,开发者可能包括内部专业团队、供应商或终端用户。考虑到这些问题,质量保证审核员需要一种工具来完成在系统创建过程中对其进行检查的任务。前瞻性检查过程就是完成这项任务的工具。这种检查包括质量保证审核员作为开发团队的一员,从计算机系统的最初创建到实施,参与新系统的开发。本报告将重点说明进行前瞻性检查过程的步骤,从预期可交付成果和文件审查到最终报告和管理层通知。还将讨论质量保证参与开发过程的好处。

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