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Validation

Interpretation, application and anticipation of legislative changes are essential elements of effective compliance strategies within regulated sectors. ETDE’s expertise in delivering validated and accredited facilities extends across the pharmaceutical, biotechnology, medical device high-risk data and high-hazard industries.

 

With a proven track record in the delivery of highly-regulated, world-class critical facilities we boast a 100% track record in process and facility accreditations.

ETDE’s validation and qualification processes capture every stage of project development from day one, providing the traceability from design through to installation, commissioning and integrated system testing.

Our tried and tested protocols and documentation-management systems have been subjected to extensive inspections and scrutiny by differing regulatory authorities over time such as the:

  • MHRA
  • FDA
  • HTA
  • HFEA
  • HSE, demonstrating our significant track record and expertise in critical market sectors.

 

ETDE’s approach to validation and qualification is an integral part of the project lifecycle, significantly reducing the intensive and complex back-end validation effort experienced on most projects. This enables us to concentrate on critical functional and system capability testing rather than document collation during the project validation phases.

 

Validation and qualification support documentation is simplified and verified at source by our engineering and client teams as part of the project construction file. Our innovative approach to compliance of facilities and associated process-manufacturing equipment, control and monitoring systems, HVAC and clean utilities means we get it right, first time.

 

We apply true project-management principles to our validation processes, combining transparent progress monitoring systems with a highly efficient, value-for-money service, ensuring our clients pay only for practical, technical solutions.

 

From independent consultative support for new and existing processes and facilities, or validation as part of a wider turnkey project solution, we have the expertise and track record from laboratory development through to manufacturing scale.