Skip to content
Qualio Home Page
Validation

Validate Qualio
with the evidence already written

Qualio supplies the requirements specifications, test cases, recorded test evidence and change history for every release, under the FDA's computer software assurance approach, so your team assures only its own configuration.

Book a demoDownload the validation approach

What's in the validation pack

Qualio builds the pack in its own Design Controls, each requirement traced to the tests that verify it, approved and versioned. Included in every plan, for every release. See Design Controls.

Requirements and trace matrix

The full requirements specification for the release, with the trace matrix linking each requirement to the tests that verify it.

Test cases

Every test case Qualio ran against those requirements, with its expected and actual result.

Video evidence

A recording of each test being run, so the reviewer sees the test itself as well as its result.

Change log

What changed in the release and why, so you can judge whether it touches how your company uses Qualio.

Qualio assures the system. You assure your configuration.

Computer software assurance splits the work. Qualio tests each release under its own quality system and supplies the pack. Your team assesses the processes and risks that depend on Qualio, tests the configuration against them and records it on the configuration assurance template.

Qualio tests and releases the software, the customer assesses configuration and risk, together validating Qualio for use

The effort follows the risk

Qualio is a quality system, not part of your product, so in most risk assessments it sits at the lower end, and the testing effort goes to the systems that carry more risk. The configuration tasks run inside onboarding, as you set Qualio up, so validation finishes when the system does.

  • Based on the FDA's computer software assurance guidance and GAMP 5 Second Edition
  • Distica cut software validation from months to weeks. Read the story.
A scale weighing CSV (computer system validation) against CSA (computer software assurance)

Each release comes with its pack

For every release, Qualio supplies the updated requirements, test cases, test evidence and change log. Your team reads the change log, decides whether the change touches your configuration, and re-assures only what it does.

Qualio release cycle with a completed assurance check

Frequently Asked Questions

Is Qualio validated?

Qualio validates each release under its own quality system and supplies the evidence. Validation for your intended use stays with you: your team assures the configuration you run, using the template Qualio provides.

Is validation included in the price?

Yes. The validation pack for each release and the configuration assurance template are included in every plan.

Does Qualio follow CSA or CSV?

Computer software assurance, as the FDA's guidance and GAMP 5 Second Edition describe it. Testing effort is set by risk, and records are kept to what that risk calls for, so a lower-risk system is not tested like a manufacturing line. What the FDA's CSA guidance means.

Do we need to run IQ, OQ and PQ on Qualio?

Qualio is cloud software, so there is no installation on your side to qualify. Your effort goes into assuring your configuration against the processes it supports, using the configuration assurance template.

What happens when Qualio releases an update?

The release ships with its own pack. Your team checks the change log against its configuration and re-assures only what the change touches.

Who signs off Qualio as a validated system?

Less time validating. More time on quality.

Bring them to the demo. We will walk through the pack for the current release and the configuration template they would complete.

Book a demo