All factories, machinery, control concepts, and systems must be qualified. This brief word 'qualified' involves a considerable amount of work and a high level of expertise. Qualification certification is documentation proving that the technical system has been constructed and installed correctly, precisely according to the specified requirements and functions outlined in the contract.
GOUP provides system certification services for projects/orders operating in regulated environments. During the validation process, we inspect all order-specific projects, as specified by the customer in the User Requirement Specifications (URS) or Failure Mode and Effects Analysis (FMEA) process, as well as projects identified and rated as critical in risk-based approaches. FMEA is developed by GOUP in collaboration with the customer within the framework of project implementation, followed by the preparation of Design Qualification (DQ), Installation Qualification (IQ), and Operational Qualification (OQ) requirements. After partial approval of the documents by the customer, testing is performed on the system or multiple systems. Testing conducted is evaluated in collaboration with the customer in IQ and OQ reports, completing the system validation process.GOUP also assists with Performance Qualification (PQ) at the customer's location.
The applicability testing described in the regulations is divided into four stages, including documentation for specific facilities.
Design qualification provides documented evidence demonstrating that the system was developed according to the requirements of its intended purpose.
Installation qualification provides documented evidence demonstrating that the facilities have been installed according to the predetermined design specifications.
Operational qualification provides documented evidence that the equipment functions according to predefined specifications.
Performance or production qualification provides documented evidence demonstrating that, under production conditions, the production process continuously produces products that meet predefined specifications.
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