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WATCH THE FREE WEBINAR: Risk-Based CAPA Under ICH E6(R3)

Clinical Trail Software Built Around You

Jay Smith, Vice President, Product Management

TransPerfect Trial Interactive Innovation

Wednesday, January 14, 2026 | 6:30 AM

Building Around How We Actually Work 

Trial Interactive is guided by a single principle: software should adapt to how clinical and quality teams actually operate, not force them into artificial constraints. 

When I think about CAPAs, which is often with mixed feelings, I often think about how it is a paper-based process that's moved to an electronic system. If you have ever found yourself in the middle of a quality event investigation, trying to collect input from multiple teams, you already know the problem: One workflow stage allows only a single person to make updates, so you start compensating with email messages, side conversations, and manual tracking. At best, it is inefficient. At worst, context is lost completely, and the CAPA is late. So, this is not a theoretical problem. It is a day-to-day reality for quality and compliance teams working under pressure. 

Over the past several months, I have spent a great deal of time listening to customers describing these situations. The recurring themes are consistent: difficulty asking multiple questions during complex investigations, CAPAs going late because effectiveness checks are not yet complete, and an increasing amount of time spent triaging inboxes instead of advancing quality. These are not abstract feature requests; they are structural friction points that slow down good teams. 

Features Designed for Transparency 

With all this in mind, quality investigations can now support many queries simultaneously, allowing the investigator to ask many questions, and allowing different teams to contribute in parallel without blocking workflow progression. Collaboration should not be serialized when the work itself is not. By keeping these conversations inside the system, teams retain context, preserve auditability, and reduce their reliance on fragmented email trails. The result is better documentation and less administrative overhead for the people responsible for quality oversight. 

We also introduced safeguards to prevent records from closing when dependent work remains incomplete. If CAPAs still have open actions or unresolved queries, the system will block closure and clearly surface what requires attention. This approach reinforces compliance expectations without introducing additional process burden. 

On the eTMF side, Document Risk Scoring adds visibility around risk. Color-coded risk indicators appear directly within document grids, highlighting gaps before they become audit issues. Rather than discovering problems late in inspection preparation, teams can prioritize remediation continuously. Event Cloning further reduces operational friction by eliminating repetitive setup work across studies and sites. 

Software That Fits Into A Regulated Environment 

A key approach to our release process is feature activation control, also called 'wire on, wire off'. New functionality is delivered in a dormant state, allowing teams to decide when and where it makes sense to enable it. You might apply Document Risk Scoring to one study while leaving others unchanged or introducing Event Cloning gradually. This flexibility recognizes the important reality that operational maturity and regulatory context vary across organizations and even across studies within the same organization. And of course, staying in a validated state requires careful configuration management, so that untested features do not get used. 

These updates were designed to integrate cleanly into the customer's current deployment model, whether operating in a multi-tenant environment, a dedicated instance, or a highly controlled enterprise configuration with specific validation requirements. 

The Operational Impact That Matters 

The real value of these enhancements is reclaimed capacity. Time previously spent reconciling emails can be redirected toward meaningful collaboration. Mental effort spent tracking dependencies manually can be applied to higher-value decision-making. Consider closing an investigation with confidence that all required input is captured in a single, auditable record. Consider entering an audit with high-risk documents already identified and addressed. Consider knowing that your system will not allow critical records to close prematurely. 

These may be incremental changes, but together they materially improve how smoothly clinical and quality operations run. Constant, iterative improvement is how we get there. 

Ready to see how these enhancements can transform your clinical and quality operations? Our team is here to show you exactly how this update addresses your specific workflows. 

Request a demo to learn more. 

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