Ketryx for Computer Software Assurance
Validation that keeps up with your team's sprints.
Ketryx turns computer system validation into a living, risk-based process, aligned with FDA's Computer Software Assurance Guidance and GAMP 5.
Problem
Traditional CSV wasn't built for teams that ship every week.
Every release means chasing sign-offs across disconnected systems, re-running scripts that already passed, and rebuilding documentation from scratch, while finished code waits on validation to catch up.
Ketryx Solution
How Ketryx
can help
Ketryx integrates with the tools your teams already use, like Jira and GitHub, and transforms them into a self-documenting, self-enforcing, self-tracing digital validation record.
Embed Risk-Based Validation
Scale rigor to risk, the way CSA intends.
Align validation effort with data integrity, product quality, and patient safety risk, instead of giving every system the same heavy treatment.
Learn how to take a risk-based approach
Release's gated on risks being acceptable and controlled.
Effort scales with data integrity and patient safety risk, not habit.
Traceability
A live requirements traceability matrix that updates as work happens.
Traceability stops being a document you assemble before an audit and becomes a state you can check at any moment.
See a live traceability matrix
Configurable traceability modes fit how your team works.
Optional full-traceability enforcement before release.
Automated Testing Evidence
Verification evidence that is continuous, not a one-time scripted event.
Your CI/CD pipeline becomes a source of validation evidence instead of a compliance blind spot.
Learn more about tracing automated tests to requirements
CI/CD test results map automatically to requirements, specs, and test cases.
When a requirement or dependency changes, the affected tests re-run automatically.
Every run adds to the validated state instead of expiring in a report.
Controlled Change Management
Keep the validated state intact as the system evolves.
Changes trigger automatic re-verification of affected items, with computational controls in place of full re-validation.
Learn more about automating change impact
Targeted re-verification of affected items, not everything from scratch.
Change-impact assessment time cut by roughly 70%.
Documentation
Release documents generated on demand from live data.
No manual binder assembly. Your documentation is a view of the system's current state.
Learn more about documentation →
Traceability matrix, test report, and risk file on demand.
Vendor software qualification records, plus other release documents, from the same live data.
"I almost can't believe it, but as your website says, we did reduce our documentation time by over 90%."
Senior Director, Quality
Top 5 pharma company
Top 5 pharma company
Top 3 Pharma
How a top 3 pharma company took its software release cycle from three months to one week
A Fortune 500 pharma company embedded compliance into Jira and GitHub, cutting release cycles from three months to one week, documentation time 70%, and tooling costs in half.
Read the case study
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