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Validate an eQMS by defining its intended use, assessing how failures could affect product quality or patient safety, and keeping objective evidence proportionate to those risks. For U.S. medical-device production and quality-system software, FDA’s February 2026 Computer Software Assurance guidance is the current FDA source. An eQMS supports regulated processes; it is not the same thing as the SaMD product whose lifecycle and regulatory status must be assessed separately.
What is in scope: the eQMS, the SaMD, or both?
Start by separating two software contexts that can exist in the same company:
- eQMS software supports quality-system activities such as document control, training, nonconformance handling, corrective actions, change control, and approvals. Assurance concerns whether the configured system reliably supports the intended processes and records.
- Software as a Medical Device (SaMD) is software that itself performs a medical-device function. Its requirements, development, verification and validation, deployment, maintenance, and eventual decommissioning belong to its product lifecycle and regulatory assessment.
A digital-health product is not automatically a medical device, and a company that builds one is not automatically subject to every device requirement. FDA’s device-software-functions approach is risk-based and depends on a function’s intended purpose and the consequences if it does not work as intended. Assess the function and the organization’s role rather than treating “digital health” as a regulatory category.
The two contexts connect through the quality system: SaMD lifecycle processes may be governed or documented in the eQMS. That does not make validating the eQMS a substitute for validating the SaMD, or vice versa.
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What changed for U.S. device quality systems in 2026?
The FDA Quality Management System Regulation (QMSR) became effective on February 2, 2026. It revises 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. FDA states that it applies to finished-device manufacturers intending to commercially distribute medical devices. Whether a particular digital-health organization, product, or process falls within scope depends on its facts and regulatory context.
For assurance of software used in medical-device production or the quality management system, use FDA’s February 2026 final guidance, Computer Software Assurance for Production and Quality Management System Software. FDA says this guidance supersedes its September 24, 2025 final guidance. It describes a risk-based approach for establishing confidence in software automation and choosing evidence and testing activities. It does not prescribe one universal eQMS test suite or fixed number of scripts.
FDA’s January 2002 General Principles of Software Validation remains relevant for general principles; FDA says the remaining sections continue to reflect its current thinking. Its former section 6 on validation of automated process equipment and QMS software has been superseded by later CSA guidance, so do not use that section as the current QMS-software guidance.
How to validate an eQMS: a risk-based workflow
The following is a practical implementation workflow based on FDA’s risk-based approach, not a verbatim FDA checklist. Scale the evidence to the system’s intended use, configuration, and potential consequences of failure.
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Define intended use and boundaries
Document which eQMS modules, workflows, user groups, records, interfaces, and regulated decisions are in scope. Identify whether behavior is standard, configured, or customized. Include dependencies that can affect the workflow or record, such as identity services, integrations, data migration, and vendor hosting. State what is explicitly outside the validation boundary and why.
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Map each process and its failure risks
For each in-scope workflow, describe what the system is expected to do and what could happen if it is unavailable, misconfigured, routes work incorrectly, or corrupts or loses a record. Consider effects on product quality and patient safety, as well as whether a failure could obscure a problem or permit an inappropriate decision. Use this assessment to set verification priorities rather than applying identical rigor to every feature.
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Review supplier and service evidence
Collect supplier materials that help establish confidence for your intended use. Depending on the service model and risk, review release and change communications, access and security controls, hosting responsibilities, backup and recovery arrangements, incident handling, and support. These are sound implementation considerations, not a complete supplier-audit checklist specified by FDA’s guidance. Decide which responsibilities remain with your organization, especially for configuration, access, process design, and release decisions.
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Turn process needs into testable requirements
Write requirements and acceptance criteria for the functions actually in scope. Depending on use, cover permissions and segregation of duties, workflow routing, approval states, audit-trail behavior, retention and retrieval, electronic-signature behavior, interfaces, migration, and reports. Link each requirement to the relevant process and risk so reviewers can see why it matters and what evidence will demonstrate it works.
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Choose verification methods that fit the risk
Use an appropriate combination of supplier evidence, configuration review, scripted or unscripted testing, scenario testing, and challenge testing. Record why the chosen method provides adequate confidence for each identified risk. Supplier documentation may contribute evidence, but it does not by itself demonstrate that your configuration, data, roles, and workflows behave as intended.
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Exercise real workflows and meaningful edge cases
Test end-to-end workflows with representative roles and data, including handoffs between people and systems. Where relevant, challenge the workflow with unauthorized actions, incomplete records, failed approvals, incorrect routing, interface errors, migration exceptions, or unavailable service. Retain enough context to identify the tested version and configuration and to understand what the result demonstrates.
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Assess deviations before release
Document failed or unexpected results, assess their impact on requirements and risk, and record corrective action and retest results. Resolve issues or assess and approve residual risk before release. The release decision should identify the software version and configuration being accepted, who approved it, and the evidence supporting that decision.
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Maintain assurance as the system changes
Define change-impact assessment and regression-testing triggers for vendor releases, configuration or process changes, integrations, migrations, and incidents. Keep an inventory of in-scope functions and dependencies, and maintain appropriate access reviews, training, backup and recovery controls, and periodic review according to risk and applicable requirements.
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Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation- Interpretation of Design Control Regulation (21 CFR 820.30)
- Practical Implementation Techniques and Best Practices
- Case Studies
- Downloadable and Editable Design and Development Document Templates
What evidence should the validation record contain?
The evidence set should make the reasoning traceable: what the system is intended to do, what could go wrong, what was checked, and why the evidence was sufficient for the identified risks. Organize records so they are attributable to the tested version and configuration and can be reviewed later.
- Intended-use statement and documented scope, including relevant modules, processes, users, interfaces, and dependencies.
- Process and risk assessment connecting potential failures to quality or patient-safety consequences.
- Requirements and acceptance criteria, with traceability to relevant risks and verification evidence.
- Relevant supplier materials and the configuration baseline, including the software version and applicable settings.
- Test approach, results, and supporting records; deviations, impact assessments, corrective actions, and retests.
- Approval and release decision, followed by change-impact assessments and ongoing assurance records.
The point is not to maximize document volume. A reviewer should be able to follow the chain from intended use and risk to the selected verification, observed result, and release decision.
How do SaMD quality principles and standards fit?
FDA’s global SaMD material describes an organizational support structure that includes leadership, accountability, governance, and resources, alongside scalable lifecycle processes for requirements management, design, development, verification and validation, deployment, maintenance, and decommissioning. FDA characterizes the IMDRF SaMD framework as harmonized quality-management principles for regulators to adopt within their own frameworks, not as regulation itself.
FDA’s recognized consensus standards listing includes ISO 13485:2016, IEC 62304, and ISO 14971 among relevant examples. Their presence on a listing does not make each standard universally mandatory for every eQMS or SaMD project. ISO 13485:2016 has the separate status of being incorporated by reference into QMSR. Determine which standards and editions apply to the specific product, submission, and regulatory pathway, and check current FDA recognition information when making that determination.
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1Fix the driver behind crashes, sound loss and screen glitches2Clear out junk files and repair common Windows errors3Scan for outdated or missing drivers - takes under a minuteThis article focuses on U.S. FDA materials. Organizations operating in the EU, UK, Canada, or other jurisdictions need to assess those jurisdictions’ requirements separately; this workflow does not establish their applicability.
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