The files should include validation protocol, validation report, evaluation and suggestions, approval person, etc.
验证文件应包括验证方案、验证报告、评价和建议、批准人等。
The aim of the validation report is to explain the operations performed in order to provide the documented evidence…
验证报告的目的是去解释所做的操作,目的是为了提供文件根据…
FDA expects a final validation report which is approved by management and which states whether or not the cleaning process is valid.
FDA要求应有一份经管理部门批准的最终验证报告,并且该报告应指出该清洗过程是否有效。
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