OUR SERVICES

UAT Services

We provide a risk-based, cross-functional UAT, while adhering to validation, and industry best practices. Our customized UAT Services will help increase sponsor and RTSM vendor collaboration, increase study team productivity, all while supporting your clinical trial timelines.

“User site testing should follow a pre-defined written plan with a formal summary of testing and a record of formal acceptance. Documented evidence of all testing procedures, test input data, and test results should be retained.”

US FOOD AND DRUG ADMINISTRATION (FDA)

STEP 1

PREPARE FOR UAT
  • Review RTSM specs and Study Protocol
  • Develop and manage UAT tasks/timelines
  • Identify risk-based test scenarios
  • Provide UAT training to Sponsor

STEP 2

DEVELOP UAT PLAN
  • Assign functional reps (Clinical Operations, Clinical Supplies, Biostatistics and Data Management, as needed) to UAT test roles
  • Finalize and approve UAT Plan
  • Coordinate UAT set-up requirements with RTSM Vendor

STEP 3

SUPPORT UAT EXECUTION
  • Lead RTSM UAT kick-off meeting
  • Support UAT real-time throughout testing
  • Maintain UAT issues log with root cause/resolution until successful close-out
  • Evaluate UAT results for completeness

STEP 4

APPROVE UAT RESULTS
  • Advise on GDocP and review risk areas for auditor enquiries
  • Draft UAT summary and route for tester approval
  • Prepare final UAT report for upload to Electronic Trial Master (eTMF)