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首页> 外文会议>American Society for Quality (ASQ)'s 57th Annual Quality Congress May 19-21, 2003 Kansas City, Missouri >LIFECYCLE FOR OFF-THE-SHELF SOFTWARE VALIDATION
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LIFECYCLE FOR OFF-THE-SHELF SOFTWARE VALIDATION

机译：现货软件验证的生命周期

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摘要

Every organization needs computer systems that reliably meet requirements and ensure data integrity and security. Many companies understand that all software is defective and that, in addition, they might inadvertently purchase an application that does not serve their needs well. In an awareness of these issues, the FDA has required that companies demonstrate that their systems are able to consistently perform to requirements, if those systems could impact product quality, or if they are used in conjunction with the electronic form of required records. FDA guidance documents and industry lifecycle methodologies have been developed to assist industry in meeting these challenges. The recently released Part 11 draft "Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application" recommends that the approach to validation be based on a justified and documented risk assessment. In this presentation, the PDA Technical Report 18 on the validation of computer systems and the "General Principles of Software Validation; Final Guidance for Industry and FDA Staff published by CDRH and CBER are integrated into a lifecycle with clearly identified deliverables. The lifecycle spans from when thought is first given to using an electronic system to its retirement. Guidance is provided on when each deliverable is needed based on the system's risk level.
机译：每个组织都需要可靠地满足要求并确保数据完整性和安全性的计算机系统。许多公司都知道所有软件都是有缺陷的，此外，他们可能会无意中购买了不能很好满足其需求的应用程序。在意识到这些问题后，FDA要求公司证明其系统能够始终如一地满足要求，无论这些系统是否会影响产品质量，或者是否与所需记录的电子形式一起使用。 FDA指导文件和行业生命周期方法已经开发出来，可以帮助行业应对这些挑战。最近发布的第11部分草案“行业指南第11部分，电子记录；电子签名-范围和应用”建议，验证方法应基于合理且有据可查的风险评估。在本演示中，关于计算机系统验证的PDA技术报告18和CDRH和CBER发布的“软件验证的通用原则；行业和FDA员工的最终指南”已被整合到一个生命周期中，并清楚地确定了可交付成果。首先考虑使用电子系统退役的时间，并根据系统的风险级别提供有关何时需要交付每个产品的指南。

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