The claim

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.

Definition

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.

Execution

Runs the floor

Receive, weigh, dispense, blend, package, label, ship — by lot or serial, with hardware (scales, scanners, printers, PLCs) wired in.

Quality

…and the QMS

Audits, NCR/CAPA, deviations, complaints, training, supplier scorecards, SCARs — fired automatically by what happens during execution.

Regime-aware

…shaped by your regulator

Profile (process / discrete / hybrid) + industry pack drives terminology, records, e-sig requirements and AI behaviour at runtime.

Pillar 01 · Defensible because…

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.

18 regimes. One platform. Zero forks.

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.

The right record, ready for the auditor

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.

E-signatures that match your regulator

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.

Real domain expertise, not just forms

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.

Pillar 02 · Defensible because…

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.

Audits

Photo validation + auto-finding draft

Native BarcodeDetector → vision OCR fallback. If a step fails, AI drafts the finding tied to operator, equipment and step.

Audits

Auto-route audit → NCR → CAPA → hold

Failed checks open the right downstream record automatically — no copy-paste between systems.

Quality

Deviation classification + CAPA suggest

Classifies the deviation, proposes containment + root cause + CAPA from history. Reviewer signs the final.

Lab

Westgard SPC + OOS triage

Real-time SPC rules, stability extrapolation, OOS investigation skeleton drafted from the run.

Suppliers

Scorecard narrator

Reads the last 4 scorecards + open SCARs + audits and writes the 3-sentence brief plus trend bullets.

Onboarding

Document → action proposals

Drop a SOP, vendor list or item master. AI proposes write actions through the same audited tool catalog the chat uses.

Procurement

Reorder + invoice AI

Reorder suggestions from consumption + lead time. Invoice OCR matches PO + receipt + tolerance.

Daily ops

Daily brief + intake pulse

What changed overnight, what needs your e-sig today, what's at risk. One screen, every morning.

Help & sales

Help AI + Ask V5 marketing

In-app help indexed against the live nav. Public Ask V5 mirrors the same register and gates CTAs by intent.

What we will never do: let AI sign records, release batches, or edit approved masters unattended. Every AI action surfaces as a proposal that a named human approves with an e-signature. The audit trail records both.

Pillar 03 · Defensible because…

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.

Step 01

Execute

Operators run the recipe / route on the kiosk. Hardware enforced. Steps cannot be skipped or out-of-sequence.

Step 02

Control

In-process checks, deviations, NCRs, CAPAs, training, supplier quality — fired automatically by execution events.

Step 03

Comply

Records render from immutable snapshots. The right template for your regime: BMR, eDHR, batch record, CoA, APR.

Step 04

Connect

Verified production posts back to your ERP / accounting system. Lots, serials, costs, variance — closed loop.

The competitive landscape

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	—
Sparta TrackWise Digital	Enterprise QMS	partial	partial	—
ETQ Reliance	Enterprise QMS	partial	partial	—
Greenlight Guru	MedDevice QMS	partial	partial	—
Qualio	Life sciences QMS	partial	partial	—
Dot Compliance	Cloud QMS	partial	partial	—
Intellect QMS	Configurable QMS	partial	—	—
Ideagen Quality Mgmt	Audits + QMS	partial	—	—
Tulip	Execution / apps	—	partial	—
Apprentice.io	Pharma execution	—	partial	—
Körber Werum PAS-X	Pharma MES	partial	—	partial
Rockwell PharmaSuite	Pharma MES	partial	—	partial
Siemens Opcenter	MES suite	—	partial	partial
Plex / Aptean MES	MES + light QMS	—	—	partial
Redzone (QAD)	OEE + engagement	—	partial	—
Parsable	Connected worker	—	partial	—
Augmentir	AI connected worker	—		—
iAuditor / SafetyCulture	Audits + checklists	—	partial	—
TrackVia	Low-code ops	—	—	—
SAP QM	ERP quality module	partial	—	partial
Oracle Quality Cloud	ERP quality module	partial	partial	partial

V5 Ultimate
Regime-aware QXS + AI
Regime-aware
Yes
AI on critical
Yes
Closes loop
Yes
MasterControl
QMS only
Regime-aware
Partial
AI on critical
Partial
Closes loop
No
Veeva Vault QMS
Pharma QMS
Regime-aware
Partial
AI on critical
Partial
Closes loop
No
Sparta TrackWise Digital
Enterprise QMS
Regime-aware
Partial
AI on critical
Partial
Closes loop
No
ETQ Reliance
Enterprise QMS
Regime-aware
Partial
AI on critical
Partial
Closes loop
No
Greenlight Guru
MedDevice QMS
Regime-aware
Partial
AI on critical
Partial
Closes loop
No
Qualio
Life sciences QMS
Regime-aware
Partial
AI on critical
Partial
Closes loop
No
Dot Compliance
Cloud QMS
Regime-aware
Partial
AI on critical
Partial
Closes loop
No
Intellect QMS
Configurable QMS
Regime-aware
Partial
AI on critical
No
Closes loop
No
Ideagen Quality Mgmt
Audits + QMS
Regime-aware
Partial
AI on critical
No
Closes loop
No
Tulip
Execution / apps
Regime-aware
No
AI on critical
Partial
Closes loop
No
Apprentice.io
Pharma execution
Regime-aware
No
AI on critical
Partial
Closes loop
No
Körber Werum PAS-X
Pharma MES
Regime-aware
Partial
AI on critical
No
Closes loop
Partial
Rockwell PharmaSuite
Pharma MES
Regime-aware
Partial
AI on critical
No
Closes loop
Partial
Siemens Opcenter
MES suite
Regime-aware
No
AI on critical
Partial
Closes loop
Partial
Plex / Aptean MES
MES + light QMS
Regime-aware
No
AI on critical
No
Closes loop
Partial
Redzone (QAD)
OEE + engagement
Regime-aware
No
AI on critical
Partial
Closes loop
No
Parsable
Connected worker
Regime-aware
No
AI on critical
Partial
Closes loop
No
Augmentir
AI connected worker
Regime-aware
No
AI on critical
Yes
Closes loop
No
iAuditor / SafetyCulture
Audits + checklists
Regime-aware
No
AI on critical
Partial
Closes loop
No
TrackVia
Low-code ops
Regime-aware
No
AI on critical
No
Closes loop
No
SAP QM
ERP quality module
Regime-aware
Partial
AI on critical
No
Closes loop
Partial
Oracle Quality Cloud
ERP quality module
Regime-aware
Partial
AI on critical
Partial
Closes loop
Partial

Comparison is based on each vendor's publicly documented capabilities. We're happy to be corrected — and will publish the correction.

People often ask how V5 Ultimate compares to MasterControl, Veeva Vault QMS, Sparta TrackWise Digital, ETQ Reliance, Greenlight Guru, Qualio, Dot Compliance, Intellect, Ideagen, Tulip, Apprentice.io, Körber PAS-X, Rockwell PharmaSuite, Siemens Opcenter, Plex, Aptean, Redzone (QAD), Parsable, Augmentir, iAuditor / SafetyCulture, TrackVia, SAP QM and Oracle Quality Cloud. Each owns a lane — V5 Ultimate is the only one swapping regulatory regimes at runtime with native AI on every critical step.

Heritage

-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.

Built and owned by SG Systems Global · since 2006

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.

Pick your industry See the full feature list