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:
- Installation qualification (IQ);
- Operational qualification (OQ);
- 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.