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Quality Assurance & Compliance

Quality Management

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.

  • Equipment/Software
  • Method
  • Cleaning

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.