【验证输出】一份好的验证报告（验证输出）应该包括哪些内容？

秘制红烧肉

9.1 There should be written reports on the qualification and validation performed. 应有书面报告记录所进行的确认和验证情况。 9.2 Reports should reflect the protocols and procedures followed and include at least the title and objective of the study; reference to the protocol; reference to the appropriate risk assessment; details of materials, equipment, programmes and cycles used; procedures and test methods; data; changes and deviations; out-of-specification and non-conformance results, with appropriate traceability; and a conclusion. 报告应反映所遵循的方案和程序，并至少包括研究的标题和目的；对方案的引用；对适当风险评估的引用；所用材料、设备、程序和周期的详细信息；程序和测试方法；数据；变更和偏差；超标和不符合的结果，以及适当的可追溯性；以及结论。 解释：这里所说的程序包括了操作、校准、维护和清洁程序（SOP），内在逻辑详见下文的补充说明。 9.3 Results should be recorded and be in compliance with good data and record management practices . 结果应被记录下来，并符合良好的数据和记录管理实践。 9.4 Results should be reviewed, analysed and compared against the predetermined acceptance criteria, interpreted and statistically analysed, where appropriate. 应根据预先确定的接受标准对结果进行审查、分析和比较，并酌情进行解释，并在适当情况下进行统计分析。9.5 Results should meet the acceptance criteria. Out-of-specification and outof-limit results should be documented and investigated according to appropriate procedures. If these are accepted, this should be justified. Where necessary, further studies should beconsidered. 结果应符合接受标准。超标结果和超出限度的结果应根据适当程序进行记录和调查。如果接受这些结果，应给出合理解释。必要时，应考虑进一步的研究。 9.6 The conclusion of the report should state whether or not the outcome of the qualification and/or validation was considered successful, and should make recommendations for future monitoring and setting of alert and action limits, where applicable. 报告的结论应说明确认和/或验证的结果是否成功，并应酌情就今后的监测和警报及行动限值的设定提出建议。 9.7 The departments responsible for the qualification and validation work should approve the completed report. 负责确认和验证工作的部门应批准已完成的报告。 9.8 When appropriate, the quality assurance department should approve the report. The criteria for approval should be in accordance with the company’s quality assurance system. 如有必要，质量保证部门应批准该报告。审批标准应符合公司的质量保证体系。补充说明：验证输出流程及要求的逻辑 Operational qualification运行确认 Requirements and procedures for operation (or use), calibration, maintenance and cleaning should be prepared before OQ and approved prior to PQ. 操作（或使用）、校准、维护和清洁的要求及程序应在OQ之前准备妥当，并在 PQ之前获得批准。 Performance qualification性能确认 Normally, PQ should be conducted prior to release of the utilities, systems or equipment. PQ should be performed under conditions simulating the intended use, to provide documented evidence that these can consistently perform in accordance with the specifications under routine use. 通常，性能确认（PQ）应在公用设施、系统或设备放行前完成。PQ应在模拟预期使用条件的工况下进行，以提供书面证据证明其能够在常规使用（按照批准好的SOP）中持续符合既定标准。

大CC

太专业了 老师

清欢度流年

大佬，我想看For example

wsx

这是哪个指南中摘录的内容？能提供原文名称吗？

xqliu

学习了，谢谢提供分享。