Best Practices for User-Acceptance Testing (UAT) in Clinical IRT/RTSM Systems

It is the sponsor’s role to accept the randomization and trial supply management systems (RTSM) for use and this process, known as user-acceptance testing (UAT), involves having the sponsor interact with the system and signing-off that it works as intended – or is fit-for-purpose. However, it is the vendor’s responsibility to ensure the system is properly validated to perform to requirements per the protocol. Still, many sponsors still feel the need to have teams full of people writing scripts and essentially revalidating the system after the vendor does. Why has UAT become an acceptable process to find bugs and quality issues in the software?

This webinar will offer best practices for UAT for sponsor organizations with the aim of changing the conversations and expectations around the UAT process. Topics to be discussed include:

• A description of UAT and what is required by regulation 
• How to assess responsibilities of both vendor and sponsor in the validation process
• Understanding what level of UAT is necessary
• Determining who should participate in UAT
• Aligning expectations of UAT – How to conduct a final check, not a bug finding exercise

Speakers

Laura Araujo, VP, Quality, 4G Clinical

Laura Araujo, VP, Quality at 4G Clinical, has over 30 years of experience in Quality Assurance and Technology, holding various positions in Software Development, Quality Assurance, Software Auditing, and Technology Management. She has had positions in, or related to, the pharmaceutical industry for 25 years. Prior to joining 4G Clinical, for 10 years, Ms. Araujo was the President and owner of Ojuara, LLC, an independent consulting firm servicing the health care and pharmaceutical industries, as well as technology development companies.

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Kathleen Greenough, Director, Client Solutions, 4G Clinical

Kathleen Greenough, Director of Client Solutions at 4G Clinical, has 16 years of experience in life sciences spanning Clinical Operations, Finance, and IT. Her wide range of solutions implementation expertise includes RTSM, CTMS, trial costing tools, OLAP financial suites and patient enrollment planning. Kathleen has also spent many years as a Clinical Financial Planner and Analyst at a major biotech in Cambridge, MA, gaining a broad and deep understanding of the challenges inherent in Clinical Development. Specializing in software adoption and a frequent speaker at industry conferences, Kathleen is most in her element when working within a user community to facilitate solutions that are insightful and truly helpful.

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