The request within the area qualification of process control systems for the pharmaceutical industry became an important component in the designing-, implementation phase and maintenance in the last years.

GESAT placed itself promptly towards these requests after the rules of the FDA (Food and Drug Administration) to put forward these projects. Our validation teams provide not only the qualification of process control systems, they also consider all boundary conditions of the instrumentation and control engineering.

We assume an important challenge for our customers, that already take in the early consulting and concept phase to a substantial success of the projects by our manufacturer-independence.

Many years of experience in diverse visualization and process control systems go hand in hand with our planning engineers and the GESAT validation teams. These advantages apply exactly the same to the prospective and retrospective validation of systems.

The following lists show an overview of the main activities for the qualification of process control systems.

	Specifications of work and services
	Duty specifications
	Change Control (modification reports)
	Design Qualification (DQ)
	Installation Qualification (IQ)
	Operational Qualification (OQ)
	Performance Qualification (PQ)
	FAT, Factory Acceptance Test (acceptance with the manufacturer)
	SAT, Site Acceptance Test (location acceptance, customer)

	Certified development and production of all hardware and software components
	Subcontractor qualification, certifying according to ISO 9000ff
	Probation by long-term application
	Function-compatible spare parts, for a defined period
	Service and engineering (regional, national)
	Standard of courses (training) for configuring, commissioning, maintenance, service
	Financial reliability
	Future reliability
	References