Validation & Qualification

General requirements of validation

The requirements in the qualification of process control systems has become for the pharmaceutical industry in recent years an important part in the planning, implementation phase and maintenance.

GESAT has early met this challenge by FDA regulations (Food an Drug Administration) and implemented in projects. Our validation team led by not only the qulification of process control systems, but also take into account all the contraints of the electrical, instrumentation and control engineering.

We have a major challenge to our customers perceived by our vendor independence, the lead early on in the consulting and concept phase to a significant success of the projects.

Our years of experience with a variety of visualization and process control systems are all about hand in hand with our project engineers and the GESAT validation team. These advantages apply equally to the prospective as well as retrospective validation of systems.

The folling tables provide an overview of the predominant activities of qualification of process control systems again.

The main features for the qualification of a control system are:

  • Specification sheet
  • Requirement specification sheet
  • Change Control (Change Log)
  • Design qualification
  • Installation qualification
  • Operational qualification
  • Performance qualification
  • FAT, Factory Acceptance Test (acceptance at the manufacturer)
  • SAT, Site Acceptance Test (locate acceptance, customer)

For the qualification of a control system the following information should be considered:

  • Certified development and production of all hardware and software components
  • Subcontractor qualification, certifying according to ISO 9000ff
  • Probation by long-term use
  • Function compatile spare party, for a defined period
  • Service and engineering (local, national)
  • Standard courses (training) for configuration, commissioning, maintenance, service
  • Financial soundness
  • Future proof
  • References