临床级干细胞实验室建设标准中英文对照.doc

临床级干细胞实验室建设标准中英文对照.doc临床级干细胞实验室建设标准
Rating Scale Definitions 评分标准
Scale
Compliance Rating, 符合状况评分
Execution rating 执行状况评分
1
No system in place 没有任何系蔬
No data generated 没有产生任何数据
2
System with major deficiencies 系统有重大缺陷
Major deviations 执行中有重大偏差
3
System with minor deficiencies 系统有非重大之缺陷
Minor deviations 执行有非重大偏差
4
System with out significant deficiencies 系统无明显缺陷
Good with out significant deficiencies 执行好，无明显缺陷
5
System is state of the art 系统非常先进
Excellent 执行优秀
System Rating 对系统的评分
Practice
Objective 目标
Compliance rating 符合情况评 分
Execution rating 执行情况 评分
Comments
评注
1
Standard Operating Procedures and
Methods
标准操作规程和方法
2
2
SOPs need to be translated.
SOP需要翻译
2
Lab Facilities and Environmental
Control
实验室设施和环境控制
3
3
Facility is of suitable size and layout, however, it does not allow for proper access/egress. No monitoring system is in place.
设施的大小及布局基本合适，但不能满足恰 当的进/出要求。没有安装监控系统
3
Equipment Maintenance and Calibration
3
2
The equipment is properly maintained and used, but no records are available.
设备保养及校准
设备保养和使用比较恰当，但无记录
4
Supplies and Reagents Management Control
耗材及试剂管理和控制
3
2
Supplies and reagents are not properly tracked during use. Records are incomplete.
耗材和试剂在使用时缺少恰当的记录。记录 不完整
5
Sample Transfer 样品转移
3
3
Current SOP needs to be updated to reflect procedure.
当前的SOP需要更新以反映当前的程序
6
Labeling Controls 标签控制
3