我司为客户提供符合欧洲FDA和GMP验证服务,符合中国2010版GMP要求的验证服务,从URS起止到RQ结束的全

程验证服务,采用欧洲传统更为复杂以及安全的W型验证模式。同时,提供整体文件体系的服务。

验证工作是贯穿在整个项目中的。在项目的不同阶段将执行不同的验证工作。

Welkin can provide qualification service from the URS to PQ meet to the requirements of FDA,GMP and cGMP and adopt W type qualification mode which is European traditional, complex and safe qualification mode.

The work of qualification is throughout the whole progress of project. In different period of project,we will perform different qualification work.

设计确认(DQ)

设计确认是对设计和用户需求(URS)的对比检查。通过对比用户需求(URS)来审核“系统功能描述”、“项目质量计划”、“详细工艺设计”、“自控系统硬件及软件设计”等文件,这样可以确认系统在设计过程中已充分考虑到用户

的全部需求。

Design qualification is to check the design compared with the URS. The files of system functional description, Project quality plan, Detail process design, Hardware and software design about control system will be examined through comparing with theURS.So we can confirmed that the design of system has fully considered the whole requirements of the clients.

安装确认(IQ)

安装确认是按照详细设计要求对已安装好的系统进行确认检查。安装确认通过文件审核确认的方式对系统中所有关

键点的软件和硬件型号以及安装是否符合详细设计要求进行确认。

Installation qualification is to check the system installedaccording to the detailed design. By means of verifying the documents, the Installation qualification is to check that whether the component type of the critical software and hardware are conforming to therequirements of detailed design or not.

运行确认(OQ)

运行确认是按照系统功能描述的要求对系统的运行进行确认检查。运行确认通过文件审核确认的方式结合现场确认的方

式对系统的工艺以及功能是否符合系统功能描述要求进行确认。

Operation qualification is to check the operation of the system according to system functional description. By means of verifying the documents combining with scene inspection,the Operation qualification is to check that whether the process and function of system are conforming to the requirements of system functional description or not.

性能确认(PQ)

性能确认是验证所建成的系统在一定期限内进行挑战性测试的情况下,能否可以稳定的运行并将所进行的验证活动书

面记录的文件。

Performance qualification is to check that whether the installed system can operate stably or not under the

condition of a challenging test in a certain period. In this period, the work of test will be recorded as qualification documents.