Validation

Validation

Executing projects across the pharma/biopharmaceutical spectrum, we offer comprehensive validation services to ensure that systems, installations and processes are compliant and fit for their intended use—and that our clients are in control.

From performing qualifications of small, stand-alone equipment to delivering major qualification scopes within large and complex EPCMV mandates, SNC-Lavalin’s Validation team delivers results that earn the confidence of regulatory authorities around the world.
Based in North America and Asia, our team of validation experts includes experienced engineers, chemists, biologists, biochemists, computer systems specialists and technicians. We work in GxP and ISO 9001 frameworks to ensure the highest compliance and traceability standards. We are able to assist clients through department management, defined scope mandates or personnel loans, as needed.

Validation services for all project types

Our expertise is both broad and specific, with Subject Matter Experts (SME`s) in each discipline, on the team. We assist clients with verifications of facilities, utilities, equipment, computerized systems, processes, cleaning, analytical equipment and method validation, and cold chain.

More specifically, our services include:

  • Validation guide, plan and master plan development and review
  • Document reviews
  • Impact, criticality, risk assessment
  • Worst-case matrix development and recovery studies
  • Specification development and review
  • FAT, SAT, DQ, IQ, OQ, PQ writing, review and execution
  • SOP writing
  • Auditing
  • Project management and planning
  • Training

Equipment and instrumentation required to execute validation projects are available in–house.

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