Why Software Validation Keeps Failing Us in Healthcare—And What We Can Do About It

From EHR upgrades and LIS replacements in the U.S. to EPR rollouts and LIMS implementations in the UK, digital transformation is reshaping healthcare delivery. But one process continues to hold us back — validation.

User acceptance testing (UAT) and software validation are meant to ensure that digital systems are safe, fit for purpose, and ready for frontline use. But the reality on the ground tells a different story: spreadsheets, folders, manual screenshots, lost issues, and overwhelmed clinical reviewers.

This isn’t a minor hiccup. It’s a systemic problem—and it’s happening in hospitals, labs, and health systems across North America and the U.K.

In our work supporting digital transformation across these markets, we’ve identified five interconnected failures that continue to undermine validation efforts. And we believe now is the time to fix them.

1. Testing Happens in the Dark

In most organizations, there is no real-time view of what’s been tested, what’s passed or failed, or which areas are still pending review. Status updates come from meetings, emails, or pieced-together spreadsheets—each telling a slightly different story.

The impact:  Delays go unnoticed. Test coverage is assumed, not verified. Go-live decisions are made on instinct, not evidence.

2. Execution Is Inconsistent

Testing is often carried out by operational or clinical experts—not professional testers. These SMEs are doing their best, but they’re often working from unclear test scripts and have little support around evidence collection or result interpretation.

The impact:  Test results vary widely between users. Evidence lacks consistency. Confidence in validation erodes across teams.

3. Defects Get Lost

When an issue is found, testers must stop what they’re doing to log it elsewhere—often in email, a help desk tool, or a shared doc. Many defects are never formally recorded. Fewer still are followed up and retested before go-live.

The impact:  Known problems slip into production. Critical issues take longer to fix. Trust between teams and vendors breaks down.

4. Clinical Review Is Disconnected

Review and sign-off is often retrospective—done after testing ends using PDF exports or screenshots. Reviewers have limited context. Approval becomes a tick-box exercise, not a safety gate.

The impact?
Clinical oversight is weakened. Issues go unchallenged. Delays mount—or worse, systems go live without full safety validation.

5. Inspection Readiness Relies on Manual Heroics

When audits come—whether from regulators, accreditation bodies, or internal compliance—teams scramble to assemble evidence. Screenshots, status logs, and sign-off trails are scattered. Preparation takes weeks.

The impact?:  Even well-executed validation efforts can’t be proven. Confidence in audit readiness suffers. Teams burn out under the pressure.

The Shift We Need: Five Strategic Objectives

These challenges are consistent across healthcare settings—regardless of geography, vendor, or system type. But they can be overcome.

Here’s what a modern, resilient validation model must include:

 1.  Real-time visibility: Central dashboards that show progress, pass/fail rates, and open defects at a glance.

2.  Structured execution: Step-by-step test scripts with clear instructions, expected outcomes, and embedded evidence capture.

3.  Integrated defect tracking: One-click issue logging inside the test flow—automatically linked to the failed step.

4.  Concurrent clinical review: Browser-based, asynchronous review that brings clinical sign-off into the testing process—not after it.

5.  Self-documenting audit readiness: Evidence and approval trails generated as testing happens—not assembled later.

What’s Next?

Healthcare can no longer afford to treat validation as a spreadsheet problem. It’s a foundational discipline—and a strategic enabler of safe, scalable innovation.

In the next article in this series, we’ll take a deeper dive into the first and most pervasive challenge: why testing still happens in the dark—and how we can bring real-time visibility to the systems we rely on most.

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🔍 Want to talk about how your organization is approaching validation? Reach out—we’d love to hear from you.