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EQUIP

Make IT validated

Computer system validation for high demands.

In a complex manufacturing process according to GAMP guidelines, continual monitoring is of vital importance. Through our 25 years of experience in the life science industry, we know exactly what it takes. Every detail of the workflow process must be subjected to scrutiny. The ongoing validation of GxP-relevant systems is one of our strengths, as well as the creation of a sustainable CSV strategy to allow for new production processes.

Our CSV specialists take care of the comprehensive validation of your GxP system and work hand in hand with your professionals in finding solutions for future challenges. Our international experience for compliant validation and comprehensive know-how about the available technology make us a competent partner for profitable production processes.

Our services in CSV:

  • CSV strategies, audits, and coaching
  • Software validation
  • Technology consulting for GxP compliant systems
  • Infrastructure qualifications
  • Risk analyzes and specification of GxP-relevant requirements
  • Fulfillment of the requirements of Swissmedic, EC and FDA
  • Preparation of all documentation
Your personal consultant

Jaroslav Karlik
Senior Project Manager

Tel.: +420 226 231 000

 

Contact us

“The requirements for GxP compliance are multilayered and complex. The right strategy accelerates projects and reduces costs.”