McDowall R D
Department of Chemistry, University of Surrey, Guildford, UK.
J Pharm Biomed Anal. 1995 Dec;14(1-2):13-22. doi: 10.1016/0731-7085(95)01629-5.
Computer validation should address the scientific correctness of the application software, the business objectives of the organisation, and the concerns of regulatory agencies. It is a balance between a practical and cost effective system that must develop the confidence that the system is under control. This paper gives an overview of computer validation from the following perspectives. What is computer validation? Why can a computer system not be completely validated? Why and how should computer systems be validated? The principles outlined in this paper should be adapted to a specific system on a case by case basis depending on its scope and complexity.
计算机验证应涉及应用软件的科学正确性、组织的业务目标以及监管机构的关注点。它是一个实用且具有成本效益的系统之间的平衡，该系统必须建立起对系统处于受控状态的信心。本文从以下几个角度对计算机验证进行概述。什么是计算机验证？为什么计算机系统不能被完全验证？为什么以及应该如何对计算机系统进行验证？本文概述的原则应根据具体系统的范围和复杂性逐案进行调整。
