Valicare offers GMP compliant qualification documents and test execution. We prepare client specific protocols that are tailored to your specific needs as a company, your specific process, and your specific process risks. Design Qualification (DQ) – Valicare prepares a DQ that defines all required functions and unit operations of the desired machine or process and makes sure that the relevant supplier documents describing the design meet the specifications. User Requirements Specification (URS) – a Valicare prepared URS categorically list all of your specific project requirements and establishes traceability, item-by-item. Installation Qualification (IQ) – we approach the IQ by writing IQ protocols that address the specifications for process relevant components as well as the interfaces to utility systems and other systems and installations. Then we execute IQ testing using our experienced field personnel. All measuring equipment used is qualified and calibrated and is compliant with international requirements for instruments. Relevant raw data are documented comprehensively and analysed for compliance. Operational Qualification (OQ) – our OQ protocols are written to test the critical system functions. Testing will cover systems functionality, operation, and required system safety. By OQ completion we are able to deliver the documented evidence that your manufacturing equipment is functioning according to defined acceptance criteria. Performance Qualification (PQ) – the PQ protocols define the required performance criteria and tests certify they are met. During PQ testing we document the evidence that your equipment is able to perform under routine and even worst-case conditions. PQ testing demonstrates that different systems are able to perform correctly “in line” and represents the documented success of your manufacturing equipment performing as an integrated system.