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风险管理是一项相对独立的具有目的性的质量活动，也可以是其它质量活动中的一项评估工具。但是在
Risk management is a relatively independent and purposeful quality activity, and can also be an evaluation tool in other quality activities. But in the
验证方案中并不是必需风险评估过程，更没有必要每个方案中都描述风险评估的原理、方法、评分标准、风险控制流程……这些应该在风险管理的工作流程
The risk assessment process is not necessary in the validation plan, nor is it necessary to describe the principles, methods, scoring standards, and risk control processes of risk assessment in each plan... These should be included in the risk management workflow
文件中规范。也没必要在方案中描述失效模式评估过程与评估结论……这些也是需要起草单独的文件，用于设备或系统的风险识别、失效模式风险评估，主要用于采取措施降低风险，对相关部件重点进行确认验证。可以不单独对“计算机控制系统”硬件软件进行评估，应该是对计算机“化”系统的整个“设备系统”在生产工艺流程中的失效模式评估。验证方案中只列出“风险评估结论”和需要确认验证的“范围程度”即可。
Specification in the document. There is no need to describe the failure mode assessment process and conclusions in the plan... These also require drafting separate documents for risk identification of equipment or systems, failure mode risk assessment, mainly for taking measures to reduce risks, and confirming and verifying relevant components. It is not necessary to evaluate the hardware and software of the "computer control system" separately, but rather to evaluate the failure modes of the entire "equipment system" in the production process of the "computerized" system. Only the "risk assessment conclusion" and the "degree of scope" that needs to be confirmed for validation can be listed in the validation plan.
关于计算机“化”系统验证确认方案
On the Verification and Confirmation Scheme of Computer "Modernization" System
既然是计算机“化”系统确认与验证，就不单单是“计算机控制系统”硬件软件的确认与验证，那么也没必要单独起草“计算机控制系统”的验证确认方案。只需要在原来“设备系统”的确认与验证文件的基础上增加“计算机控制系统”的“基础构架的确认”和“应用软件的验证”内容，对于计算机控制的设备、系统而言，也不存在独立于设备之外的计算机系统验证。如果是因为以前做过的设备确认验证中没有认真做计算机控制部件的确认，那么你想补充确认计算机系统硬件软件，也是可以的，但严格说并不是单独的一类验证。
Since it is the confirmation and verification of computerized systems, it is not just the confirmation and verification of hardware and software of computer control systems. Therefore, there is no need to draft a separate verification and confirmation plan for computer control systems. It is only necessary to add the content of "infrastructure confirmation" and "application software verification" of "computer control system" to the original confirmation and verification files of "equipment system". For computer controlled equipment and systems, there is no independent computer system verification outside of the equipment. If it is due to the lack of careful confirmation of computer control components in previous equipment validation, it is also possible to supplement the confirmation of computer system hardware and software, but strictly speaking, it is not a separate type of validation.
关于“计算机控制系统”硬件软件的确认与验证
Confirmation and Verification of Hardware and Software for "Computer Control System"
这一部分虽然不需要单独拿出来做，但是很多企业还是会单独做，那么如果你的计算机“化”系统的“设备系统”已经做了确认和验证的，单独做计算机控制系统的硬件软件的确认就是重复劳动，没有必要。在“设备系统”的确认与验证中增加的“计算机控制系统”硬件软件的确认与验证，遵循GAMP5
Although this part does not need to be done separately, many companies still do it separately. Therefore, if the "equipment system" of your computer "transformation" system has already been confirmed and verified, doing the hardware and software confirmation of the computer control system separately is repetitive work and unnecessary. The confirmation and verification of the hardware and software of the "computer control system" added in the confirmation and verification of the "equipment system" follows GAMP5
规范中的软件分类及验证方法。
Software classification and validation m风险管理是一项相对独立的具有目的性的质量活动，也可以是其它质量活动中的一项评估工具。但是在
Risk management is a relatively independent and purposeful quality activity, and can also be an evaluation tool in other quality activities. But in the
验证方案中并不是必需风险评估过程，更没有必要每个方案中都描述风险评估的原理、方法、评分标准、风险控制流程……这些应该在风险管理的工作流程
The risk assessment process is not necessary in the validation plan, nor is it necessary to describe the principles, methods, scoring standards, and risk control processes of risk assessment in each plan... These should be included in the risk management workflow
文件中规范。也没必要在方案中描述失效模式评估过程与评估结论……这些也是需要起草单独的文件，用于设备或系统的风险识别、失效模式风险评估，主要用于采取措施降低风险，对相关部件重点进行确认验证。可以不单独对“计算机控制系统”硬件软件进行评估，应该是对计算机“化”系统的整个“设备系统”在生产工艺流程中的失效模式评估。验证方案中只列出“风险评估结论”和需要确认验证的“范围程度”即可。
Specification in the document. There is no need to describe the failure mode assessment process and conclusions in the plan... These also require drafting separate documents for risk identification of equipment or systems, failure mode risk assessment, mainly for taking measures to reduce risks, and confirming and verifying relevant components. It is not necessary to evaluate the hardware and software of the "computer control system" separately, but rather to evaluate the failure modes of the entire "equipment system" in the production process of the "computerized" system. Only the "risk assessment conclusion" and the "degree of scope" that needs to be confirmed for validation can be listed in the validation plan.
关于计算机“化”系统验证确认方案
On the Verification and Confirmation Scheme of Computer "Modernization" System
既然是计算机“化”系统确认与验证，就不单单是“计算机控制系统”硬件软件的确认与验证，那么也没必要单独起草“计算机控制系统”的验证确认方案。只需要在原来“设备系统”的确认与验证文件的基础上增加“计算机控制系统”的“基础构架的确认”和“应用软件的验证”内容，对于计算机控制的设备、系统而言，也不存在独立于设备之外的计算机系统验证。如果是因为以前做过的设备确认验证中没有认真做计算机控制部件的确认，那么你想补充确认计算机系统硬件软件，也是可以的，但严格说并不是单独的一类验证。
Since it is the confirmation and verification of computerized systems, it is not just the confirmation and verification of hardware and software of computer control systems. Therefore, there is no need to draft a separate verification and confirmation plan for computer control systems. It is only necessary to add the content of "infrastructure confirmation" and "application software verification" of "computer control system" to the original confirmation and verification files of "equipment system". For computer controlled equipment and systems, there is no independent computer system verification outside of the equipment. If it is due to the lack of careful confirmation of computer control components in previous equipment validation, it is also possible to supplement the confirmation of computer system hardware and software, but strictly speaking, it is not a separate type of validation.
关于“计算机控制系统”硬件软件的确认与验证
Confirmation and Verification of Hardware and Software for "Computer Control System"
这一部分虽然不需要单独拿出来做，但是很多企业还是会单独做，那么如果你的计算机“化”系统的“设备系统”已经做了确认和验证的，单独做计算机控制系统的硬件软件的确认就是重复劳动，没有必要。在“设备系统”的确认与验证中增加的“计算机控制系统”硬件软件的确认与验证，遵循GAMP5
Although this part does not need to be done separately, many companies still do it separately. Therefore, if the "equipment system" of your computer "transformation" system has already been confirmed and verified, doing the hardware and software confirmation of the computer control system separately is repetitive work and unnecessary. The confirmation and verification of the hardware and software of the "computer control system" added in the confirmation and verification of the "equipment system" follows GAMP5
规范中的软件分类及验证方法。
Software classification and validation methods in the specification.
如果是因为以前做过的设备确认验证中没有认真做计算机控制部件的确认，那么你想补充确认计算机系统硬件软件，也是可以的，但严格说并不是单独的一类验证。
If it is due to the lack of careful confirmation of computer control components in previous equipment validation, it is also possible to supplement the confirmation of computer system hardware and software, but strictly speaking, it is not a separate type of validation.
If it is due to the lack of careful confirmation of computer control components in previous equipment validation, it is also possible to supplement the confirmation of computer system hardware and software, but strictly speaking, it is not a separate type of validation.
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This article is organized and published by a computerized system validation company. Do you have any understanding of these contents? For more information, please click on: https://www.fmkgmp.com We will have more exciting content waiting for you to check out.