Report approval 报告批准 Including audit trail review as part of the batch report where exceptions are reported 将审计追踪审查作为批报告的一部分,以报告例外情况 Technical controls to ensure audit trails are always active 技术控制以确保审计追踪始终处于激活状态 2Calibration 校准 “You failed to calibrate...
Your firm did not execute a validation protocol including a validation summary report for the software Electronic Logbook System Version 1.0.0.” [38] “贵公司在2号工厂中使用电子日志(eLog)1.0.0版系统来记录所有活动,包括实验室设备和生产的数据分析结果。贵公司进行了变更控制#CCP-IO-135-14-0009,...
Proving completely and with expert knowledge. A systematic approach is essential here: structured, planned, coordinated. gempex is familiar with all forms of qualification planning as well as the corresponding records and report templates. Optimised templates developed in house – or by request also cu...
A Unifying Strategy for Data and System Governance 数据和系统管理的统一策略 之前在建体系的时候，DI...
A validation report that cross-references 应当拟定一份能交叉引用验证方案的 the validation protocol should be prepared, summarizing the results obtained, commenting on any deviations observed, and drawing the appropriate conclusions, including recommending changes to correct deficiencies. 验证报告,概括得到的...
Compliance with Industry Standards: This GMP ISO CE certificated air shower meets the rigorous standards of the food and electronic industries, ensuring a high level of cleanliness and hygiene in manufacturing plants, food & beverage factories, and clean room fields. It is designed to provide a sa...
In lieu of such testing by the manufacturer, a report of analysis may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer, and provided that the manufacturer establishes the reliability of the supplier...
Assigning an inspection rating 9 Appendices 10 Appendix A – Sample observations 10 Premises 10 C.02.004 10 Equipment 12 C.02.005 12 Personnel 13 C.02.006 13 Sanitation 14 C.02.007 – C.02.008 14 Raw material testing 15 C.02.009 – C.02.010 15 Manufacturing control 16 C.02.011 – C....
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WHO Technical Report Series, No. 961, 2011 Annex 10附件10 for prequalification of pharmaceutical ...