Process validation is an essential step to ensure that our processes are consistent, efficient and compliant with legislation and customer requirements.
Through our validation team, we can confirm that our products are designed, manufactured and tested to meet regulatory requirements and quality specifications. In the case of medical products, validation can include several steps, such as performance testing, clinical trials, risk analysis and regulatory compliance audits. In this way, we ensure that the product brought to market is safe, effective and reliable for patients and healthcare professionals.
Validation is generally required by regulatory agencies such as the FDA in the United States or the European Medicines Agency (EMA) in the European Union before the product is marketed.
The MPS validation team is actively involved in the acquisition of equipment. It develops specifications and defines the technical characteristics as well as the acceptance criteria. When a new piece of equipment is received, the validation team performs tests to ensure that it meets the requirements.
In addition to the equipment, the validation department also ensures that all the information systems used in the company are maintained in a validated state. Periodic process reviews are performed, and memos and amendments are issued to ensure that everything is in compliance with process specifications.
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