Qualification Services

PCI's Qualification Services

In addition to startup and commissioning, PCI has experience with all aspects of equipment qualification requirements.  Whether you have plant utilities, critical process utilities, or production equipment, we have the expertise and experience to deliver customized and compliant testing verification services.Qualification

All activities are documented with Good Documentation Practices and are designed to make sure your facility is fully tested and qualified to function in the way it was intended.  Not only is this approach an industry standard, but it gives you the confidence that you can operate in a highly systematic and controlled environment.

Our Qualification Consultants are experts at:

Installation Qualification (IQ) - verifies the proper installation and configuration of a System. This can include ensuring that necessary files have been loaded, equipment has been installed, the necessary procedures have been approved, or the appropriate personnel have been trained.

Operational Qualification (OQ) -verifies the proper functioning of a System.  This testing ensures all aspects of a facility, utility, or equipment that can affect product quality operates as intended throughout all anticipated ranges.

Performance Qualification (PQ) - verifies the System performs as intended.  This testing ensures system performs as expected under simulated real-world conditions.

In addition to qualification services PCI has the expertise to deliver additional compliance requirements including:

  • User and Functional Requirement Specifications
  • Validation Master Planning
  • Operational Procedures
  • Maintenance and Calibration Programs
  • Quality and Compliance Program Services
  • Change Management
  • Analytical Equipment Qualification
  • Deviation and Investigation Management