Qualification

Qualification tests establish confidence that the process, equipment and ancillary systems are capable of consistently operating within established limits and tolerances. To clarify all activities and to define the responsibilities is the basis for individual qualification or validation studies. It is most important to meet the requirements of the operator, following the motto “as much as necessary but not as much as possible“. Many factors have an effect on a process or its results. To take into account all the factors it often makes sense to rate them by means of a risk analysis. Risk analysis allows critical factors to be discovered in time and allows necessary actions to be taken during planning.

Sometimes the amount of inspection has been defined by standards or manufacturer recommendations. In this case it is common just to add individual or process oriented requirements.

You should always count qualification and validation as quality assurance elements, independent on regulatory affairs. Correctly planned and performed, practically all studies give proof of process parameters, which are essential to rate the quality of a product.

Re-qualifications, if performed periodically, give you information about the long-term behaviour of an instrument or a process and may contribute to identify creeping changes in time.

We provide the following tests:

• DQ – Design qualification
• IQ – Installation qualification
• OQ – Operational qualification
• PQ – Performance qualification

Validation
A validation mostly consists of different tests, such as:

Design Qualification – DQ

Design qualification defines the functional and operational specifications of the instrument and details the conscious decisions in the selection of the supplier.

Installation Qualification – IQ
Documented verification that all key aspects of hardware installation adhere to appropriate codes and approved design intentions and that the recommendations of the manufacturer have been suitable considered.

Operational Qualification – OQ
Documented verification that the equipment related system or subsystem performs as intended throughout representative or anticipated operating ranges.

Performance Qualification – PQ
Documented verification that the process and/or the total process related system performs as intended throughout all anticipated operating ranges.

Please apply for an individual offer.