What are the 3 Stages of Process Validation?

Process Validation is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical devices.

The Three Stages of Process Validation

  • ·         Process Design
  • ·         Process Validation or Process Qualification
  • ·         Continued Process Validation



IZiel team makes all efforts to understand the process in detail and investigate the applicable standards and guidelines to determine the process requirements. IZiel’s approach has been very comprehensive and methodical as depicted in the flowchart.

IZiel has successfully delivered various projects through the Onshore-Offshore Work Model, completing projects faster and with major cost savings. The IZiel team works together with the client to plan, execute, compile reports, and receive stakeholder approvals for all process validation projects.

IZiel’s Onshore-Offshore Model works with 1 Onsite Member supported by a team of 3-4 engineers from our Technical Center in India. Typically, the data is collected, evaluated and evidence is developed from the process design stage throughout the production. Our Model enables the company to complete the project faster and in a cost-effective manner.



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