What is eQMS Software Validation?

Electronic Quality Management System (eQMS) validation is a structured, planned, and documented process designed to verify that the software performs according to specified requirements. It ensures the system supports intended quality processes, and complies with industry regulations such as FDA 21 CFR Part 11 and ISO 13485.

How Cognidox supports validation

Cognidox supports customer-led validation with full transparency and guidance. You retain control of your processes, while we provide the tools and documentation to help validate faster and with confidence.

• Designed for ISO 13485 and FDA 21 CFR Part 11
• Validation-ready, without adding weight to your processes
• Test documentation and risk templates included with every release

What documentation do we provide?

Cognidox provides a comprehensive set of validation documents and outputs to support a range of validation approaches.

Whether you choose traditional IQ/OQ/PQ methods or a modern, CSA (US FDA Computer Software Assurance) aligned approach, we can supply:

• Design documentation – system architecture, module design, and integration summaries
• Requirements traceability – clear mapping between features, regulatory requirements (e.g. 21 CFR Part 11), and test cases
• Test plans and reports – includes over 1,900 unit tests and 723+ functional tests with detailed test scripts and results
• Validation Risk Assessments – templates tailored for CSA and ISO/TR 80002-2:2017 validation frameworks
• Installation & Operational Qualification checklists – pre-filled IQ/OQ templates to simplify initial deployment checks
• Change logs – track functional changes, bug fixes, and security updates by version
• Internal validation protocols – evidence of testing performed before release, including user testing in a live environment

All documentation is structured to help you:

• Document your validation rationale clearly
• Minimise time-to-validation
• Maintain audit-ready records

Our validation methodology

Our validation process is transparent and rigorous, Cognidox is tested and validated at every release.

How we validate each release:

• Unit testing: 1,942+ test scripts run continuously in CI to verify individual components
• System-level testing: 723+ automated UI tests using Selenium to simulate user behaviour across core functionality
• Regression testing: Full system retested on every major release
• Internal deployment: Limited release within Cognidox for live usage and user feedback

Validation methods we support:

We align with both traditional validation frameworks and the newer CSA model (specially designed for quality and production software validation):

• Installation qualification (IQ): We provide checklists to verify correct installation and system configuration
• Operational qualification (OQ): Our internal test evidence confirms functionality across user roles and use cases
• Performance qualification (PQ): Clients can validate against their intended use - supported with editable PQ test cases and risk templates

And for CSA-aligned teams:

• Tiered validation by intended use and failure risk
• Documented rationale using our Validation Risk Assessment templates

We don’t just tell you it’s validated - we show you how, and give you the artefacts to prove it.

“I worked closely with Cognidox's team to review and enhance their QMS software validation practices. I was very impressed with their robust software development practices, the level of automated testing which is run continuously and their knowledge and commitment to excellence in their validation practices.”

- Carla Sivak Principal Consultant at Sivak Associates LLC

Validation that works for you

Whether you're:

• Building a validation file from scratch,
• Updating for a new release,
• Or adopting a risk-based CSA approach,

Cognidox provides the tools and documentation teams need to validate their systems on their own terms - rather than forcing them into a one-size-fits-all approach like many other eQMS providers.

This can mean using pre-supplied templates and test evidence to support internal protocols, or helping clients take full ownership of the process by defining, executing, and documenting validation independently:

“With Cognidox, we did all of the validation ourselves. We used Cognidox validation documents as reference, but they were our user requirements; we tested them, we made up the tests for them.”

— Brianna Gerlach, QA/RA Manager, BAAT Medical

Standards & References

Validation is supported by international standards and guidance, including:

• ISO/TR 80002-2:2017 – Software in medical device QMS
• FDA 21 CFR Part 11 – Electronic records & signatures
• FDA CSA Guidance (2022) – Risk-based assurance (suitable for Quality and Production Software)
• MHRA GxP Data Integrity Guidance (2018)

How to use our validation docs

Cognidox gives our clients the structured documentation, traceability, and real test outputs they need for internal sign-off and external audits of their validation process.

With our documentation pack, you can:

• Validate new deployments or upgrades
• Supplement your own PQ testing
• Meet CSA expectations without over-testing
• Cut down time-to-validation from months to weeks
• Maintain audit-readiness with real test evidence