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Qualification and Validation

Achieve and maintain regulatory compliance with our Qualification and Validation services

Qualification and Validation 


Galenisys assists you in verifying that all equipment, systems, and processes meet required standards. Our experts meticulously plan and execute qualification and validation activities to ensure that your operations are robust, reliable, and compliant with industry regulations. Whether you are launching new facilities or optimizing existing ones, our services help you achieve seamless compliance, reducing risk and accelerating time-to-market

Galenisys can help you create:

  • Master validation programmes
  • Protocol definitions
  • Qualification definitions
  • Report formats
  • Approval stages, responsibilities and processes
  • Qualification studies for sterilisation equipment and processes
  • Calibration programmes and methods

We can also help you ensure you meet your compliance targets through training, project management, quality audits and troubleshooting quality issues. 


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