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Validate an electronic quality management system (eQMS) by defining what it will do, assessing how failures could affect product quality or patient safety, and retaining objective evidence proportionate to that risk. For U.S. medical-device production and quality-system software, FDA’s February 2026 Computer Software Assurance guidance is the current FDA source for a risk-based approach. The eQMS’s assurance is separate from the lifecycle validation and regulatory assessment of the SaMD product itself.
First determine whether the eQMS and product are in scope
“Digital health” is not a single FDA regulatory category. A company’s regulatory obligations depend on the software function, its intended purpose, the organization’s role, and the applicable regulatory pathway—not simply on whether it develops an app or uses an electronic quality platform.
FDA’s Quality Management System Regulation (QMSR) took effect on February 2, 2026. It revises 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. FDA describes its scope as finished-device manufacturers intending to commercially distribute medical devices. A software supplier or digital-health business is not automatically in scope merely because it offers software or uses an eQMS; assess the organization, products, and activities against the rule.
For product software, make a separate function- and intended-use assessment. FDA’s device-software-functions guidance distinguishes functions that are not devices, device functions for which FDA intends enforcement discretion, and functions that are the focus of oversight. The relevant question is what each software function does and what risk follows if it fails—not whether the product is broadly described as “digital health.”
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Keep eQMS assurance separate from SaMD lifecycle work
An eQMS supports regulated processes such as document control, training, nonconformance handling, corrective and preventive action, and design control. SaMD is software that itself performs a medical-device function. The same company may need to manage both contexts, but assuring the system that records quality work does not validate the medical software product.
| Question | eQMS software | SaMD or device-software function |
|---|---|---|
| What is being assured? | The configured or customized platform and its use in specified quality-system processes. | The device software function, including its intended purpose and lifecycle activities. |
| What drives the assessment? | How system failures, incorrect configuration, unavailable service, or record errors could affect quality or patient safety. | The function’s intended use and the risk if it fails as intended or affects a traditional device’s functionality or performance. |
| What work is involved? | Risk-based assurance of the workflows, records, controls, integrations, and service model in scope. | Lifecycle processes such as requirements management, design, development, verification and validation, deployment, maintenance, and decommissioning. |
FDA’s global SaMD page describes organizational support—leadership, accountability, governance, and resources—along with scalable lifecycle processes. It also says the IMDRF SaMD framework provides harmonized quality-management principles and “are not regulations.” Use that framework as a quality-management reference, not as an independent legal requirement.
What changed for U.S. quality systems in 2026?
QMSR is now effective
As of February 2, 2026, the QMSR is the current U.S. quality-system regulation for finished-device manufacturers intending commercial distribution. It incorporates ISO 13485:2016 by reference. Confirm applicability to your organization rather than assuming every eQMS provider or digital-health company is a finished-device manufacturer.
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FDA’s current eQMS assurance source is the February 2026 CSA guidance
FDA’s final guidance, Computer Software Assurance for Production and Quality Management System Software, describes a risk-based approach for software used in medical-device production or the quality management system. FDA says it supersedes the final guidance issued September 24, 2025. Its purpose is to help establish confidence in automation, determine where more rigor is appropriate, and select methods and testing activities that produce objective evidence. It does not prescribe one universal eQMS test suite or fixed number of scripts.
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Standards require an applicability check
FDA’s recognized consensus standards listing includes ISO 13485:2016, IEC 62304, and ISO 14971 among examples relevant to medical-device software and quality-system considerations. ISO 13485:2016 has the distinct status of being incorporated by reference into QMSR. A standards listing does not make every listed standard mandatory for every eQMS implementation or SaMD project. Check the FDA recognition database and determine whether a standard applies to the particular product, activity, and regulatory pathway.
How to validate eQMS software for a medical-device quality system
The sequence below is a practical way to apply risk-based assurance. Adapt it to the organization, system configuration, regulated processes, and applicable requirements; it is not a verbatim FDA checklist.
1. Define intended use and boundaries
Write down which modules and workflows the eQMS will support, who will use them, and which decisions or records are regulated. Identify interfaces, electronic signatures, data migration, hosting, identity services, and dependencies that affect those workflows. State whether the system is used as supplied, configured, or customized, and set a clear software and configuration baseline.
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For every in-scope workflow, describe what the system is expected to do and the consequence if it does not. Consider incorrect routing, missing or corrupted records, an unauthorized approval, a failed interface, or service unavailability. Link each material risk to the process control and the evidence needed to show that control works. Give greater rigor to failures with greater potential impact on product quality or patient safety.
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3. Assess the supplier and service model
Review supplier materials relevant to your intended use and the risks you identified. Implementation considerations include release and change communications, access and security controls, incident handling, hosting, backup and recovery, availability, and support. Assess what evidence the supplier can provide and which risks still require organization-specific review or testing. These considerations help make a risk-based assurance case; they are not a claim that FDA’s guidance prescribes this exact supplier checklist.
4. Set testable requirements and acceptance criteria
Translate process needs and identified risks into requirements that can be evaluated. Depending on scope, specify expected behavior for permissions and segregation of duties, workflow routing, approval states, audit trails, record retention and retrieval, electronic signatures, integrations, migration, and reporting. Define what counts as passing before testing begins, and connect each requirement to its risk and planned evidence.
5. Select verification methods proportionate to risk
Use an appropriate combination of supplier evidence, configuration review, scripted or unscripted testing, scenario testing, and challenge testing. Record why the selected method provides enough confidence for each risk. Risk-based assurance does not mean omitting objective evidence when the risk calls for it; the rationale should make the relationship between risk, method, and result clear.
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6. Exercise real workflows, including negative cases
Test end-to-end scenarios using representative roles and data. Where relevant to the implementation, challenge the system with unauthorized actions, incomplete records, failed approvals, incorrect routing, interface errors, migration exceptions, and unavailable service. Confirm that expected controls operate and that failures are visible and handled as intended.
7. Resolve deviations and approve release
For each failure or unexpected result, document its impact, corrective action, retest, and any residual risk. Keep results attributable to the tested software version and configuration. Release approval should show that acceptance criteria have been met or that any remaining risk has been assessed and formally accepted by the appropriate authority.
8. Maintain assurance as the system changes
Define when changes trigger impact assessment and regression testing. Relevant triggers can include configuration updates, vendor releases, process changes, integrations, migrations, and incidents. Maintain controls such as access reviews, user training, backup and recovery, and periodic review at a frequency appropriate to risk and applicable requirements.
9. Keep an auditable evidence set
Retain records that explain both what was done and why it was sufficient for the risks in scope. A practical evidence set includes:
- Intended-use statement, system boundaries, and configuration baseline.
- Process and risk assessment, with requirements traceability and acceptance criteria.
- Relevant supplier materials and the rationale for relying on them.
- Assurance plan or method rationale, test scenarios, attributable results, and deviations.
- Release decision and approvals, followed by change-impact assessments and ongoing assurance records.
How to judge whether the assurance is adequate
A defensible assurance record lets a reviewer follow the chain from intended use to process risk, requirement, verification method, result, and release decision. Ask whether the evidence addresses the actual configured system and real users, whether important failure paths were challenged, and whether changes after release will be assessed. The answer is not the size of the test-script library; it is whether the evidence provides confidence proportionate to the risks and can be understood later.
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