Quality Assurance & Compliance
Validation and Qualification
We can assist with accessing the needs with by developing and execution of documents that provide a high degree of assurance that a specific process, method, or system will consistently produce as a result, meeting predetermined acceptance criteria.
We can generate protocols and reports as well as participate in the execution of protocols.
Below are protocols used to define tests that will demonstrate the processes can consistently and repeatedly produces the desired products.
Installation Qualification (IQ): documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations and/or user requirements.
Operation Qualification (OQ): documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges.
Performance Qualification (PQ): documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications.
Validation Summary Report (VSR): documents the validation completeness and system readiness to be used in a production environment. The report will also document any constraints or limitations that have been placed on the production use of the system.