审计结果(实验室) audit packages - 仪器信息网.pptVIP

Audits Examination 审计考察 Validation (Inc. Cleaning Validation) 验证(包括清洁验证) GAMP IV V compliance for Annex 11 and Part 11 附件11与地11部分GAMP IV与V符合性 Feedback loops (cross departmental collaborations) 反馈环路(交叉部门合作) Sub-Primary Causes 次要原因 Of all the above, the validation seems to be the one critical area that requires clarification of roles and responsibilities; borders and the communication, including validation status within the laboratory in all areas: test methods; analytical; equipment; instrumentation, etc. 综上所述,验证似乎是需要澄清的作用和责任,边界和沟通的一个关键领域,包括实验室所有方面的验证状态; 测试方法;分析;设备;仪器仪表等 Audits Exam