QAU

QUALITY

  • PhenoPath has an independent, on-site Quality Assurance Unit (QAU) with several decades of combined experience in CLIA, GLP and GCP environments
  • Comprehensive Quality Management System, including:
    • All processes governed by SOPs
    • Change control
    • Procedures for preventative and corrective actions (CAPA)
    • Quality metrics
    • Competency assessments of technical staff 
  • Quality Control procedures are designed and managed by study personnel to ensure the accuracy and integrity of all data reported
  • All transcribed data is subjected to 100% quality control checks by laboratory staff prior to submission to the client 

REGULATORY COMPLIANCE

  • CAP accreditation for high-complexity testing under CLIA
  • Licensed laboratory in CA, FL, MD, NY*, RI, and WA (*subset of services)
  • Studies performed in accordance with GLP/GCP, as applicable
  • Clinical Trial and Research activities at PhenoPath will be conducted according to PhenoPath's Standard Operating Procedure (SOPs) and the following:
    • ICH Guideline for Good Clinical Practice (E6)
    • Good Clinical Laboratory Practices as outlined in the WHO "Good Clinical Laboratory Practices Guideline"
    • European Medicines Agency (EMA) "Reflection Paper for Laboratories that Perform the Analysis or Evaluation of Clinical 

PhenoPath Licensure and Accreditation »

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