MAR is focused on customer’s total satisfaction, reason why preparation of Validation Protocol in accordance with cGMP and GAMP standards is one of the main activity of our engineer’s team.
The purpose of validation is to establish documented evidence providing a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications (requirements) and quality attributes.
The main stages are indicated below:
- User Requirements Specification (URS)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
MAR supplies FAT (Factory Acceptance Test) protocol validation and SAT (Site Acceptance Test) protocol; on request IQ & OQ protocols (Installation Qualification & Operational Qualification).
The complete validation test for the equipment will be performed at MAR’s site, following complete test list included in the FAT Protocol.
MAR can perfom if requested, as an optional service, SAT Protocol or IQ-OQ validation Protocol at customer’s site.