QUALITY & COMPLIANCE SERVICE

Quality and Compliance Management is of paramount importance at Exom. Genius eQUAM™ our quality management platform is the cornerstones of our quality system aiming to help our clients ensure the integrity of their clinical trials as well as the protection of research subjects’ rights and welfare. Genius eQUAM™ accelerates review and approval workflows, and facilitates sharing of GxP documents among employees and partners. Genius eQUAM™ enables proactive mitigation of issues, effective documentation management and reduced compliance risk. It allows effective, real time and complete CAPA management.

Benefits of Genius eQUAM™

  • Gaining control of GxP documents
  • Greater user adoption
  • Increased efficiency
  • Better Quality Management
  • Audit & Inspection Readiness
  • Accelerates review and approval workflows facilitates sharing of GxP documents

Services

  • Clinical investigator site audits (routine, directed, specialized and pre-inspection audits to help sites prepare for regulatory agency reviews)
  • Quality Control (QC) of the study eTMF
  • Clinical database audits and study report reviews
  • System and study-specific audits
  • Vendor qualification audits
  • Independent on-site audits
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