General request of validation

The request within the area qualification of process control systems has become an important component in the designing, implementation phase and maintenance for the pharmaceutical industry 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 not only provide the qualification of process control systems, but they also consider all boundary conditions of the instrumentation and control engineering.

We notice 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 both to the prospective and retrospective validation of systems.

The following lists are a synopsis of the main activities for the qualification of process control systems.


The Chief characteristics for the qualification of a control system are:

• 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)

For the supplier qualification of a control system the following specifications are to be considered:

Future security References

• 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