On its own comparison page Qualio writes that it is built exclusively for life sciences, contrasting itself with a competitor that serves aerospace, automotive and food and beverage. That is a clear answer to a fair question. If your obligations are AS9100, AS9120 or ITAR, this is the platform written for them.
Nothing on this page is a claim about what Qualio can or cannot do. It is what they publish about who they built for, and what we built instead.
Every one of these is live today. Every one files a record you can hand to an auditor.
The AI reads. A rules engine decides. That split is what makes the output defensible evidence instead of an opinion.
Drop in the whole receiving package. It classifies 17 document types, runs about 40 checks, validates the CAGE code against SAM.gov, tests the source against your own approved supplier list, and cites every finding to the standard and to your customer's flow-down.
It reads the paperwork, not the parts. The review that ate an afternoon takes minutes, and a named human still signs the disposition.
Attach the drawing and ask. It balloons every accountable characteristic per AS9102 Rev C and drafts the forms into a numbered record.
You do not fill out a form. You ask, and the first article builds itself.
Check your first article before your customer does. Including the characteristic count mismatch that bounces most packages.
Catch the rejection at your desk instead of at theirs.
Screens a party against the U.S. Consolidated Screening List, walks the ITAR and EAR fork, and files the determination once a qualified person signs.
It never clears a party on its own. A named human signs, and the record proves it.
Procedures, audit plans, corrective actions, management review packs, system security plans, job hazard analyses, end user statements.
Drafted against the standard you hold, in your language.
Every morning it hands you what needs you today. Reviews due, acknowledgments unsigned, findings about to breach, training about to expire.
Thirty seconds instead of twenty minutes of digging.
The second time is always faster than the first, because the system already knows the answer and who signed it.
You load a prime's flow-down and your own receiving procedure once, and approve them.
Every trace review from that point is checked against both, clause by clause, with the citation shown. You approved it once. It applies every time.
Fit is not a feature comparison. It is whether the standards you are audited against appear anywhere in the product.
You do not need a better life sciences platform. You need one where AS9120 is a first-class standard rather than an absence.
Every line in the left column is what Qualio publishes about itself. We do not characterise a competitor's capability and we do not claim they cannot do things.
Describes itself as the agentic compliance platform for life sciences, and writes that it is built exclusively for life sciences.
Built for aerospace, defense and regulated manufacturing, by an auditor who has run these audits from both chairs.
Published frameworks centre on ISO 13485, FDA QMSR, EU MDR, IEC 62304 and MDSAP.
AS9100D, AS9120, ISO 9001, ITAR and EAR, CMMC and NIST 800-171, with the prime's flow-down loaded as a clause library.
Design controls and a design history file sit at the centre of the product.
Receiving inspection, first article and traceability sit at the centre, because that is where distributor and build-to-print risk lives.
Published modules do not include receiving-inspection trace package review.
Seventeen document types read in one pass, every finding cited to the standard and to your customer's flow-down.
No published pricing, and an implementation fee applies to all plans.
No published pricing either. What you get before commercials is your own environment, seeded with your own standard.
If you are a medical device or pharmaceutical company, their fit is better than ours and we will tell you that on the call.
Not a general purpose AI tool with a compliance label stuck on the front.
I have written the corrective action, and I have been the one who rejected it. That is the difference between a tool that sounds right and one that survives contact with an auditor.
Omie Trikha, founder, QMS Leader
Nearly two decades implementing and auditing quality systems for aerospace, defense, and manufacturing. Every play in it came off a real floor.
Built on a commercial AI agreement that contractually bars the provider from training on your data. Not a setting somebody has to remember to switch off.
AS9100D, ISO 9001, ISO 13485, ISO 14001, ISO 45001, IATF 16949, ISO 27001, CMMC and NIST 800-171, ITAR, FDA 21 CFR 820, OSHA.
The dashboard and the evidence package were built for the person who has to hand something to a registrar, not for a marketing page.
Everything below is included. Nothing below is an upsell.
This is the first question every quality director asks, so it gets answered before you book anything. Send your security questionnaire ahead of the demo and we will return it completed, line by line.
The one with the missing certificate and the broker in the middle. We run it live and you judge the verdict against what you would have called yourself.