About
We build one thing: a quality system that enforces its own rules.
This page is short on purpose. Who we are, why we built QAbility, and the four ways we run the company that you can check for yourself.
Who we are
QAbility, in four facts.
- What we make
- Quality management software: deviations, nonconformances, CAPAs, change control, documents, training, audits, complaints and supplier quality, in one system with one audit trail.
- Who it’s for
- Regulated manufacturers, and the quality teams who answer to an auditor, including teams working to 21 CFR Part 11 and ISO 13485.
- How we sell
- Directly, with published plans. We scope the rollout with you and walk the product through your own processes before you buy. There is no self-serve trial.
- How we ship
- Monthly. The changelog starts with the first version in January 2026 and has an entry for every month since.
Why we built it
Audits find the step someone skipped.
A missing document is easy to spot. The expensive gaps are quieter: a record closed while a task was still open, a change made after the approval, a signature nobody can tie to a person.
A system that only stores records lets those gaps through and leaves them for the audit to find. We built QAbility to refuse them when they happen, and to keep the evidence where an auditor can read it.
A nonconformance, CAPA or change request moves only along its lifecycle. Any other status change is refused.
Database refusesA nonconformance won’t close while a workflow step is open or the disposition is missing.
Server refusesA signature asks for a dedicated signature PIN again and records what the signature meant.
Server refusesThe audit log refuses updates and deletes, so a change is added to the history instead of replacing it.
Database refuses
How we operate
Four habits you can check. Each one links to where you can see it.
Prices in the open.
Plans and rates are published, along with who counts as a user and who never does. Suppliers, shop-floor staff and people completing training are free.
See pricingStraight answers, including “no”.
Our FAQ says what the product doesn’t do, as plainly as what it does. You can’t sign up for a self-serve trial, and we would rather tell you that now.
Read the FAQA changelog, every month.
What shipped, month by month, written for the people who use it. Only work that has shipped goes in it.
Read the changelogClaims we won’t make.
We don’t call the software “Part 11 compliant” or “validated”. Compliance rests on your procedures and your validation. We publish where the software’s part stops.
Read the Part 11 checklist
Talk to us
See it on your own process.
Tell us the process you want to see, and we’ll walk it through QAbility on a call.