doesthe original model need to be implemented with the newstandard requirements? - 分享质量人的知识和经验

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doesthe original model need to be implemented with the newstandard requirements?

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If Change of Permission Items indicates addingof models, meanwhile new standards are involved,doesthe original model need to be implemented with the newstandard requirements?

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ku13145 二阶会员用户来自于: 广东省深圳市
2023-09-17 16:47

For instance, the registered models are A and B,and thenew models are C and D. Then, for the new models, they shall beimplemented with the requirements of the new standard, and thetesting report and/or verification/validation data shall be providedIf the original models A and B are not changed, then no relevantinformation is needed and new standard is not added into the ProductTechnical Requirements. Administrative counterparts shall ensurethat A and B can also meet the requirements of the new standardfrom the date of implementation of the new standard.If new standard is added into the Product TechnicalRequirements, testing reports and/or verification/validation data shallbe submitted to certify A and B could meet the modified ProductTechnical Requirements.

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发布时间: 2023-09-17 16:47

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