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)
Strategic UAT Services
Are you looking for support beyond the standard UAT services?
Poxy Clinical offers a full array of strategic UAT services to create synergy across IRT stakeholders, including Sponsor cross-functional teams, IRT vendors and UAT consultants. We have experience tailoring our support to meet the individual needs of each sponsor.
OUR MOST COMMON REQUESTS FOR STRATEGIC SUPPORT INCLUDE:
Evaluating and drafting standard operating procedures (SOPs), and working instructions (WIs)
Developing sponsor-specific UAT acceptance training manuals and videos
Drafting UAT communication plans
RTSM / IRT vendor assessments tools (market scans, capability assessment, vendor scorecards)
“The sponsor is ultimately responsible for the validation of the computerised system and for providing adequate documented evidence on the validation process.”
EUROPEAN MEDICINES AGENCY (EMA)