Validating special processes

How important is the validation of special processes? Why do we validate special processes?

A special process is a process that provides a product whose compliance with the requirements cannot be 100% controlled routinely (e.g. cleaning, sealing, sterilisation).

Validation of a special process allows you to demonstrate that your process provides repeatedly a reproducible, efficient and consistent product. In general, the validation of a process is carried out in three phases:

  1. Installation qualification (IQ);
  2. Operational qualification (OQ);
  3. Performance qualification (PQ).

All these validation steps must be defined and documented in a quality management system.

The nex’valid solution accompanies you at all stages of validation of your special processes

  • Definition of the special process;
  • Drafting of the validation protocol;
  • Realisation of validation according to the protocol (IQ, OQ or PQ method);
  • Development of the validation report;
  • Definition of routine checks and parameters required for revalidation.

Benefits of nex’valid for your business

  • Your medical devices meet predefined specifications, and the standards and regulatory requirements;
  • The validation process improves the quality of the finished products and reduces manufacturing costs;
  • A validated method can reduce significantly the time to market for similar new products;
  • Training gives you the skills and tools necessary to implement a special process validation.

What happens in case of non-compliance?

A non-validated special process can lead to the marketing of a product that does not comply with regulatory requirements. The notified body may then raise critical non-conformities and suspend the marketing authorisation.

Another consequence may be required to significantly modify the process, resulting in lost time and considerable financial loss.

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