V-Module valaidation period and document framework

When Shanghai Ritai supplies high quality equipment, we also provide valaidation support for clients,  including DQ, IQ, OQ, and necessary PQ. The valaidation support of Ritai acts as per V Module. For high quality valaidation requirement project, we can provide more complete and perfect valaidation service. We provide all documents of project based on our QMS:

●Quality and project plan
●Design documents
●Validation plan
●Certification files
●Technical document, after the project commissioning is completed.
●Service manuals for equipment, Original equipment manufacture Manuals.
●Consumption Backups of User Programs / Applications, Original licenses.

Regulatory requirements for pharmaceutical process systems during verification and testing. Our full set of verification systems and documents are based on FDA, EU GMP, and Chinese cGMP requirements. They mainly include and not only include:

●Validation Plan
●Quality and project plan
●Risk Assessment
●Change control
●Non-conformance 
●Design Review and Requirements Traceability Matrix
●Specification: MDS, HDS, FS
●SDS
●FAT/SAT
●Installation Qualification
●Operational Qualification
●Performance Qualification support