Definition of product quality and quantified performance characteristics, including MTBF, consumption, serviceability etc. • Complete investigation of real and possible risks including harms to personnel, environment and equipment with cross reference to adequate tests.

Definition of how to proceed Qualification: Design and approval of Master Qualification Plan • Design of required form sheets • Introduction or extension of Change Management procedure.

Design and approval of test plans and other form sheets required for all phases of Qualification tests • Check of completeness and plausibility of technical design documents, certificates, SOPs and instruction of operating personnel.

Correctness of mechanical & electrical installation • Proof of GMP & FDA conformity of materials, components, liquids, etc. • Results of calibration • Proof of safety measures, etc. • Correct functions and operation acc. to functional specification.

Proof of product quality • Test of performance / reliability / serviceability, consumption, etc. of the plant / machine / equipments • Iterative fine tuning • Final acceptance test • Qualification Report • Release for Production.