No-one likes scattered spreadsheets and outdated IQ/OQ/PQ documents.

Be faster with a system that uses item-based CSV management as the foundation for your CSV work.

Keep track of the software assets relevant to the success of your medical device in a single location.

You gain clarity, control, and confidence in knowing that your CSV landscape is always up-to-date.

Keeping the of records of your CSV assessments proves your systematic and compliant approach.

A risk-based CSV evaluation, leaning on ISO 13485 and FDA QSR 820 guides your decision process. By assessing impact, complexity, and intended use, the system helps you determine which software must be validated.

Your validation plans and reports are built on a transparent, traceable rationale that stands up to inspection.

And furthermore, being able to demonstrate the documented and deliberate reasons why you have not validated a particular software, is sometimes just as valuable for compliance as the CSV itself.

Our item-based system connects features, functions, requirements, with tests, either AI-supported scripted tests or exploratory tests, all depending on the verdict of your risk-based assessment.

Every change is tracked, every test traceable, providing a total transparency from concept to compliance. Continuous, real-time consistency checks make sure that no requirements remain untested, and no test slips through unexecuted.

Deliver traceable validation results designed for audit readiness and regulatory reliability.

Compliance doesn’t stop after go-live, and neither does the Aligned eQMS CSV process.

With built-in reminders, periodic assessments are not forgotten, and your CSV work remains complete, correct and compliant. You’ll know exactly when your systems need to be re-assessed due to changes in the software itself, its intended use, external regulation or your risk appetite.

This proactive process helps you stay ahead of regulators and avoid costly surprises, so validated stays validated, year after year.