User Acceptance Testing is a critical stage for clients to identify issues before the Randomization and Trial Supply Management (RTSM) system is approved for live use. Undetected issues present a huge risk to patient safety, the integrity of the clinical trial - potentially costing the sponsoring Biotech company millions of dollars in damage. Poxy Clinical provides UAT services throughout the testing lifecycle while adhering to test methodology, industry, and FDA guidance.
We routinely engage with the RTSM vendor, and clinical team to understand the study design and requirements. A robust test strategy is defined in the UAT plan.
As the UAT primary point of contact, we provide support throughout UAT execution. We manage issue reporting to resolution, enabling the clinical team to focus on their expertise.
We consult the clinical team on how to document test results and append supporting evidence. Solid UAT documentation mitigates auditor inquiries while adhering to FDA guidelines.