From “Validation” to “Assurance”: What the FDA’s New Computer Software Assurance Guidelines Mean for Clinical Labs Using QMS Software

If you’ve been living in the world of “validate everything,” the FDA’s Computer Software Assurance (CSA) guidance is welcome news—especially for quality management system (QMS) software like document control, training/competency assessment, CAPA/NCE workflows, supplier management, internal audits, and dashboards. The shift is simple but powerful: put effort into the highest risk areas, and keep evidence lean and useful.

Below, we explain what changed, what doesn’t change, and how MediaLab and our clients can each play their part—efficiently, confidently, and in a way that stands up to inspection.

Old mindset (General Principles of Software Validation, 2002): Treat all software through a one-size-fits-all validation lens—heavy planning, scripted tests, and binders of screenshots.

New mindset (Computer Software Assurance, 2025): Establish assurance that the system is fit for its intended use, scale activities by risk, and capture appropriate records (often the digital evidence you already have). For inherently lower-risk QMS tools, that means fewer scripted test cases, more real-world scenarios, and lighter documentation—without sacrificing control. The FDA encourages a “least burdensome” approach.

In short: Less ceremony, more confidence. Focus on what could plausibly impact patient safety, product quality, or record integrity—and right-size everything else.

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What this means for QMS platforms like MediaLab

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• Risk profile: QMS software is not a medical device or embedded firmware that poses a direct risk to patient safety or production quality. For most clinical labs, it sits in a low-risk category, since the records and insights presented by QMS software will always be mediated by your team.

• Right-sized activities: Use a few unscripted, scenario-based checks that mirror how your teams really work (e.g., “approve a controlled document,” “complete a training assignment,” “process an IQE CAPA form end-to-end”).

• Modern evidence: Rely on system logs, audit trails, and concise notes instead of screenshot packs. Record who tested, what they tried, what happened, and the conclusion.

• Rely on MediaLab’s documentation: MediaLab’s applications, software design methodology, infrastructure, and cybersecurity are independently validated and verified by SOC 2 and FedRamp auditors. These audits go far deeper than end-user testing could.

• No duplication: You don’t need to “re-validate the vendor.” Validate your intended use and configuration. Leverage MediaLab’s SOC2 and FedRamp compliance as part of your risk assessment.
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Shared responsibilities (clear and simple)

What MediaLab will do:

• Keep showing our higher standards. We continue to develop, test, and release using rigorous controls aligned to regulatory expectations.

• Demonstrate strong trust posture. MediaLab is SOC 2 accredited and FedRamp authorized, underscoring our commitment to security, availability, and confidentiality.

• Deliver clear release notes and system updates. We communicate what changed, what matters, and any actions customers may need to take.
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What we ask clients to do:

• Document your intended use (at a high level). Most organizations have 5–10 use cases across all apps. Keep it simple (one or two lines each), e.g.

“track non-conforming events, include electronic signature” or “ensure policies and procedures are approved by lab directors.”

• Classify risk appropriately. For QMS software like MediaLab, document the rationale that it is low risk to patient safety and production. QMS software isn’t autonomously modifying processes, changing manufacturing parameters, or releasing test results.

• Run “a few” unscripted test scenarios that reflect real-world. Examples:

• Document Control: Create → edit → approve → release a SOP; verify performing employee signoffs are made
• Compliance & CE and Compass: Assign a course or competency; learner completes; supervisor verifies.
• IQE: Start a test NCE event, walk through the steps in your test form, and close it.
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• Record succinct results. Capture: tester, date, scenario, pass/fail, and any issues observed. Use the system-generated documentation provided by MediaLab – a screenshot of the completed test IQE event, cut-and-paste the audit trail for a document.

• Avoid unnecessary duplication.

No repeating the software maker’s internal validation.

No “dozens of scripted test cases.” A handful of meaningful scenarios beats volume.

A lightweight template you can copy-paste

Intended Use Summary

• Application: e.g., Document Control

• Purpose: e.g. Manage controlled documents, approvals, versioning and employee signoff

• Records Impacted: e.g. approved SOPs, non-conforming events

• Risk Statement: e.g. Low risk to patient safety/production; errors would be detected via QA review, training verification, and release controls

Assurance Activities

• Method: e.g. Unscripted scenario testing + configuration verification

• Scenarios (3–6 total): Brief bullets describing use case and intended result

• Evidence: Execution notes + system audit trails/logs (a screenshot, part of the system audit trail)

• Conclusion: Acceptable for intended use as configured; issues tracked in CAPA if found
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That’s it. No screenshot novels. No 50-step scripts. Just real-work scenarios and clear outcomes.

Why this stands up to inspection

Inspectors want to see that you:

1. Understood what the system is for (intended use),

2. Assessed realistic risk,

3. Chose proportionate activities, and

4. Kept appropriate records showing the system performs as you actually use it.

The CSA approach delivers exactly that—clean, defensible, and efficient.

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Final thought

CSA doesn’t lower the bar; it moves the spotlight to where it belongs. For QMS software, that means less busywork and more meaningful evidence. MediaLab will keep shipping secure, high-quality updates with transparent release notes and SOC 2 backing. You validate your use and configuration, not our source code—and you do it with a few smart scenarios that reflect the way your teams work.