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.
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.
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.
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.
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.