Commissioning & Qualification

A modern and integrated approach.

Technical Qualification

Why?

Every tool used in the manufacturing process has a high impact on product quality.

What is included?

  • Qualification Protocols Writing and Execution
  • Installation, Operational and Performance Qualification
  • Validation Master Plan
  • Commissioning Plan
  • Cleaning Validation
  • Process Validation
  • Media Fill Protocols
  • Calibration services
  • Witnessing of Supplier Testing Activities (FAT/SAT support)
  • Inventory of Process Equipment and Utilities
  • Quality Risk Management
  • User Requirement Specifications
  • Technology Transfer
  • Process Analytical Technology (PAT) Support
  • Clean Room Qualification
  • Temperature Mapping Services
  • Transport Validation

We know what we are doing.

Don’t believe us? Check out the material put together by our team of experts.
Technical Qualification Annex
Annex I update

Sterile facilities are a complex context: from process equipment qualification to clean utilities, our guide can help you understand the newest regulation related to the Annex I update of the Eudralex.

Technical Qualification Webinar
Webinar

Browse our Knowledge Gallery and view our free webinar about how to design a strategic site master plan when building your facility or view another of our free webinars available in your language.

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