Process Validation for Medical Devices:

Process Validation for medical devices is conducted to ensure consistent delivery of quality products meeting its predetermined specifications and quality characteristics. Typically, the data is collected, evaluated and evidence is developed from the process design stage throughout production.

It is vital to understand the process in detail, investigate the applicable standards and guidelines to determine the process requirements. Process Validation for medical devices includes various steps –

  • Process Validation Master Plan (PVMP)
  • Process Characterization
  • Equipment Installation and Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Test Method Development (TMD) & Validation (TMV)

IZiel Approach:

IZiel’s approach has been very comprehensive and methodical as depicted in the following flowchart.

process-validation

IZiel considers the following factors for the completion of process validation projects –

  • Methodical approach
  • Execute validation project with an onshore-offshore team with a ratio of 1:3
  • Shorter Timelines and Budgets