QC-EQP-010-01-UV-530-紫外分光光度计验证方案!.docx

UV 530紫外-可见分光光度计验证方案
Qualificati on Protocol for UV/VIS Spectrophotometer
**** UV 530
F/QC/EQP-010-01
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REVIEW AND APPROVAL OF VALIDATION PROTOCOL
Prepared by
起草人
Title
职务
Sig nature
签名
Date
日期
Reviewed by
审核人
Title
职务
Sig nature
签名
Date
日期
Approved by
批准人
Title
职务
Sig nature
签名
Date
日期
1.
验证目的( Purpose)
2.
3.
4.
5.
6.
目录
TABLE OF CONTENTS
引用标准( Reference Documentation)
系统描述( System Description)
职责( Responsibilities)
检查者( Operator )
审核者( Reviewer)
负责人( Manager)
验证的管理( Qualification Management)
人员( Personnel)
记录和数据( Data Assembly)
文件要求( Documentation Requirements)
偏差处理( Deviations)
再验证( Requalification)
验证检查和测试( Qualification & Tests )
5..
.5..
.5.
.6..
.6..
.6..
.6.
.7.
.7.
.7.
.7..
7..
.7..
.8.
.8.
8..
安装确认 (Installation Qualification, IQ)
仪器的组成信息( Composition of the Equipment )
紫外 -可见分光光度计的性能描述 ( Description of the Specifications of the Equipment )
8
售后服务( Service)
8
文件的确认和保管( Documents Verification & Storage )
8.
安装环境确认( Verification of Installation Environment )
9.
设备信息( Equipment Information )
9..
安装确认的结果及结论( Result & Conclusion of installation Qualification ) 1..0
运行确认( Operation Qualification, OQ )
...
测试项目和认可标准( Test items and Acceptance Criteria)
...
( Materials & Reagents)
1..1.
.1..1.
软件系统安全性确认( Verification of the Safety of Software )
波长准确度（
Wavelength accuracy)
1..1.

Absorption accuracy)
1..2..
杂散光检查（
Stray Light )
1..2..
吸收度线性（
Absorption Linearity )
.1..2.
( Absorption cell match )
...
运行确认的结果及结论( Result & Conclusion of Operation Qualification )
..
性能确认 (Performance Qualifica