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Qualification & Validation

From Engineering to Validation

 

For successful investment projects we handle the end-to-end coordination and execution of field engineering activities. We also provide commissioning and qualification till process validation following the industry’s best practices for the regulatory acceptance of your investment.

 

We focus on regulatory compliance for Requirement Specifications, Equipments, Facilities & Utilities Qualification, as well as Cleaning & Process Validation. Depending on your needs and internal practices, we will use the most adapted approach(es):

  • V-Cycle
  • GAMP 4 - Risk-based approach
  • GAMP 5 - Integrated Commissioning & Qualification
  • Lean approach
  • ASTM E-2500-07

 

Our consultants are fully trained on Project Management practices, Prince 2 and/or PMI to run your Qualification and Validation projects with efficiency and rigor.

 

 

 

 

 

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