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Qualification and validation

Certified systems for international production

Qualification is an essential part of quality management in the pharmaceutical and medical-device industries, enabling the validation of manufacturing processes. Qualification documentation is evidence that a system functions properly, and produces the expected results – products of consistently high quality.

sortimat supplies assembly systems for pharmaceutical and medical-device manufacturers complete with the necessary qualification documentation for design, installation and operation (DQ, IQ, OQ). As a result, systems can be rapidly put into production – saving you the cost and effort of in-house qualification.

We provide qualification on the basis of the internationally accepted Good Automated Manufacturing Process (GAMP 5) standards.

If you have any further questions, please contact our qualification expert

The route to qualification:

sortimat validation

		Project plan Hand in hand with you, we develop a tailor-made qualification project plan. This outlines precisely which tests and tasks sortimat will carry out to ensure the provision of the necessary documentation.

		Risk analysis sortimat performs this assessment on the basis of Failure Modes and Effects Analysis (FMEA), and in accordance with GAMP 5 guidelines.

		Qualification stages Systems undergo clearly defined tests, and the findings are documented as evidence that all equipment works properly and produces the expected results.

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