Validation

Validation is the systematic documentation of the process and product. The use of validation ensures a uniform product quality for the customer.

The demand for documentation of the process has never been larger than at present. Therefore, AMP A/S can also offer qualification and validation of the products that we deliver to our customers.

Qualification and validation includes moulds, machines axillary equipment and the process.

  • Qualification.

After the completion of the trial runs, and the optimal process parameters have been found, the O-serie can be started. Here over a period of time samples parts are taken for measurements and capability studies where the Cp and Cpk values will be documented.

  • Validation.

Validation includes IQ (installation Qualification) OQ (Operation Qualification) and PQ (Process Qualification). For the PQ there will be conducted three independent trial runs.

There will be prepared a validations protocol and hens forth a validation report.

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