Audit-Ready UAT: A Sponsor’s Guide to Global Compliance

In today’s increasingly complex clinical trial landscape, small- and mid-sized sponsors face mounting pressure to demonstrate ownership of their systems, especially when it comes to IRT User Acceptance Testing. Regulatory bodies like the FDA, EMA, and MHRA have made it clear: sponsors are ultimately responsible for ensuring that systems used in clinical trials are fit for purpose. Yet for many sponsors, UAT can feel like a gray area. Who writes the scripts? What does “fit for purpose” really mean? And how do you prove it to an auditor?

At Clinical Supply Consulting (CSC), we’ve seen firsthand how a lack of standardization in IRT User Acceptance Testing can lead to confusion, delays, and even compliance risk. That’s why our UAT Services Group is focused on helping sponsors bring structure, clarity, and confidence to their UAT documentation—without overcomplicating the process.

Why Standardization Matters

When UAT is treated as a checkbox activity, executed with generic scripts or loosely defined scenarios, it often fails to reflect the real-world operational flows of a trial. This not only diminishes the value of the testing itself but also increases the risk of trial delays and leaves sponsors vulnerable during regulatory inspections.

Standardization doesn’t mean rigidity. It means having a consistent, auditable approach that:

• Aligns with global regulatory expectations for sponsor oversight
• Reflects the actual protocol and supply strategy
• Produces clear, traceable documentation that stands up to scrutiny

What Sponsors Need (and Often Lack)

Many small sponsors rely on their IRT vendors to guide UAT, but this can blur the lines of sponsor oversight. Vendors are validating their own systems; they’re not positioned to test from the sponsor’s operational perspective. What’s often missing is:

• Protocol-driven test scenarios that reflect real supply chain decisions
• Traceability matrices that link requirements to test evidence
• Risk-based testing that aligns with regulatory expectations

CSC’s UAT Services Group is designed to fill this gap, providing sponsors with tools, templates, and guidance to take true ownership of IRT User Acceptance Testing—even if they don’t have in-house expertise.

A Scalable Solution for Growing Sponsors

Whether you’re preparing for your first IRT deployment or scaling up for a global Phase III program, our approach is built to flex with your needs. We support both client-led and SME-led execution models, tailoring our deliverables to your trial’s complexity and risk profile.

Most importantly, we help you build a UAT package that goes beyond compliance—instilling confidence in your system, safeguarding patients, and standing up to the toughest regulatory scrutiny. Contact CSC today to learn how our UAT services can help you achieve audit-ready compliance that protects your timelines and delivers study success.