The world's first regime-aware quality execution system, AI-assisted on every critical step.
That's a big sentence. This page is why we say it — and why nobody else can.
What we mean by regime-aware QXS.
A quality execution system (QXS) runs the shop floor and the quality system in the same workflow — execution and compliance are the same action, not two systems pretending to talk. Regime-aware means the platform knows which regulator your workspace lives under, and reshapes itself accordingly: terminology, records, e-signature rules, report templates, AI behaviour. One codebase. Thirteen regimes. No "modules" to bolt on.
Receive, weigh, dispense, blend, package, label, ship — by lot or serial, with hardware (scales, scanners, printers, PLCs) wired in.
Audits, NCR/CAPA, deviations, complaints, training, supplier scorecards, SCARs — fired automatically by what happens during execution.
Profile (process / discrete / hybrid) + industry pack drives terminology, records, e-sig requirements and AI behaviour at runtime.
Regime awareness is structural, not cosmetic.
Most "industry-specific" platforms ship one product and rename buttons. V5 swaps the actual rules. A pharma tenant sees Formula → MMR → BMR with two-person e-sig on every removal. A medical-device tenant on the same codebase sees Product → DHR → DMR with serial-level genealogy. A radiopharma tenant gets isotope master, A(t)=A₀·e−λt decay maths and conditional release per 21 CFR 212.70(d). Same kiosk. Different regime. No fork.
- Pharma, supplements, food, bakery, sausage & meat, dry mixes, produce, cosmetics, agrochem
- Medical devices, consumer products, contract manufacturing, radiopharmaceuticals
- Kiosk tiles, navigation, report names and AI prompts all reshape to your regulator
Pick your industry on day one and the whole platform speaks your language — no consultants, no custom build, no "module" upsell.
- BMR for pharma · eDHR for medical device · batch production record for food & supplements
- CoA, APR, lab dossier, training certificate and migration closeout — built-in
- Every report rendered from an immutable, time-stamped snapshot of the approved master
When the inspector arrives, the record is already complete, signed, and defensible — produced as an "accurate reproduction" of the master your team approved.
- Two-person approval on formula release for pharma, supplements, devices, cosmetics, agrochem
- Lighter-touch sign-off for food, bakery and produce — without losing traceability
- 21 CFR Part 11, 211.186, 111.205, 820.40 and MoCRA enforced automatically by role
The right number of signatures, by the right roles, on the right transactions — so your team can't accidentally do it wrong.
- Radiopharma isotope decay built in — 17 nuclides, half-lives, conditional release
- Nutrition panels and USDA lookups for food regimes only
- Allergen handling for sausage & meat, withdrawal periods for agrochem
-36 years on regulated floors baked into the product — surfaced where it matters, hidden where it doesn't.
AI is woven through execution, not bolted on as a chatbot.
Every AI write is auditable, reversible, and Part 11-safe. Proposals → human approval → e-signature → audit trail. No "the AI did it" — every action has a human accountable on the record.
Native BarcodeDetector → vision OCR fallback. If a step fails, AI drafts the finding tied to operator, equipment and step.
Failed checks open the right downstream record automatically — no copy-paste between systems.
Classifies the deviation, proposes containment + root cause + CAPA from history. Reviewer signs the final.
Real-time SPC rules, stability extrapolation, OOS investigation skeleton drafted from the run.
Reads the last 4 scorecards + open SCARs + audits and writes the 3-sentence brief plus trend bullets.
Drop a SOP, vendor list or item master. AI proposes write actions through the same audited tool catalog the chat uses.
Reorder suggestions from consumption + lead time. Invoice OCR matches PO + receipt + tolerance.
What changed overnight, what needs your e-sig today, what's at risk. One screen, every morning.
In-app help indexed against the live nav. Public Ask V5 mirrors the same register and gates CTAs by intent.
It closes the compliance loop end-to-end.
Shop floor execution → controls → legislative compliance → verified production back to the ERP. One platform, one audit trail, one source of truth — sitting alongside the ERP you already paid for. No rip-and-replace.
Why nobody else can say this today.
Each of the obvious comparables picks one lane. None swap regulatory rules at runtime AND assist with AI on every critical action.
| Platform | Lane | Regime-aware | Native AI on critical steps | Closes the loop |
|---|---|---|---|---|
| V5 Ultimate | Regime-aware QXS + AI | |||
| MasterControl | QMS only | partial | partial | — |
| Veeva Vault QMS | Pharma QMS | partial | partial | — |
| Tulip | Execution / apps | — | partial | — |
| Redzone (QAD) | OEE + engagement | — | partial | — |
| iAuditor / SafetyCulture | Audits + checklists | — | partial | — |
| Plex / Aptean MES | MES + light QMS | — | — | partial |
Comparison is based on each vendor's publicly documented capabilities. We're happy to be corrected — and will publish the correction.
-36 years on the regulated floor.
V5 Ultimate is the cloud-native successor to V5 Traceability, the on-premise platform that has run weighing, dispensing and batch execution inside FDA-, EMA- and GFSI-audited plants since 2006. Same team. Same standards. Same phone number. New architecture — built so we could finally make the shop floor and the QMS one system, with AI on every critical step.
See it on your regime.
Pick your industry — V5 will spin up a workspace with your terminology, your reports and your e-signature rules already in place. Free, no card.