QUALITY MANAGEMENT SYSTEM (eQMS) · REGULATED MANUFACTURING
The quality system that keeps up with your quality team.
Deviations, corrective actions, documents and training in one place, with an owner on every open item and closure times on the front page — so nothing waits on someone’s memory or a spreadsheet.
Not ready for a call? Join the waitlistFrom the team behind Elevated Signals, with years of experience supporting regulated manufacturing operations.
03 · THE KPI CHECKED FIRST
The number inspectors ask for first.
How long it takes you to close a CAPA or a deviation is one of the first things an inspector or your leadership team asks for.
Most quality systems make someone build a report to answer it. Invariant puts it on the front page, live, with the trend and the owner of every open item.
Where SLA management is switched on, it also lets you manage due-date targets by severity, business days on your own holidays and time zone, with a second person’s password required to extend a deadline.
Illustrative sample workspace — your numbers are calculated from your own records.
04 · CAPABILITY TOUR
Nine areas of quality work. One record model underneath.
Documents, deviations, CAPAs, change control, training, complaints, tickets, batch context and reporting. One audit trail runs under all of them.
Deviations
Log it, classify it, assign an investigator, and work a structured 5-Whys or fishbone. No close without a root cause and a linked decision.
Many capabilities on this page — including finalization gates, SLA management, automated retraining and in-app alerts — are switched on per organization during onboarding rather than being on by default. We will show you exactly what your workspace includes on the call.
05 · THE CLOSED LOOP
The step where CAPAs quietly die.
Ask any quality team where CAPAs go to die and they will say the same thing: retraining.
The plan says “retrain the team,” the meeting ends, and nobody schedules it.
Where automated retraining is switched on, Invariant creates the training assignments from the CAPA action itself, the named people complete and sign for the training in the app, and the CAPA will not close until that evidence is there.
06 · THE PRODUCT
See Invariant in motion.
Illustrations of Invariant’s screens, with sample data.
07 · WHAT CHECKING IT ACTUALLY LOOKS LIKE
LIVE TODAYThe record underneath it all
Every change Invariant records is sealed to the one before it, per organisation, and a built-in verifier re-checks the whole chain and names the first record that does not match. AI actions are recorded in that same history, attributed as AI.
Anyone can say their history is trustworthy. In Invariant there is a button that re-checks it, and if the history does not hold it names the record that broke and why. Below is that check passing, and the same check after we deliberately altered a past record.
We run this live in demos — ask us to break it in front of you.
Interactive illustration of a check we ran in a test workspace. Record IDs are from that test; hashes are illustrative.
The check ran in a test workspace built for this, never against customer records.
What a passing check shows
A passing result demonstrates that the stored chain is internally consistent at that as-of time — it does not prove completeness against a privileged wholesale rewrite or tail deletion without an external anchor.
// 08 · AI-NATIVE BY ARCHITECTURE
Everyone says they have AI. Ours leaves evidence.
Invariant treats AI as an actor in the record: it drafts a deviation investigation, and that draft is written into the same sealed history as your people’s actions, recorded as the work of AI.
Most quality systems can now generate an investigation for you. We could not find one that publicly documents what the machine actually did.
AI never closes a record, never signs, and never puts its own words into an investigation on its own — a person accepts or dismisses each part, with a reason, and that boundary is enforced in the server, not just on the screen.
These controls are designed to support 21 CFR Part 11 and EU Annex 11 expectations; they are not a compliance conclusion.
The record underneath it all
AI actions are recorded in that same history, attributed as AI.
See the check ↑AI drafts the investigation
On a deviation under investigation, AI drafts the investigation for a person to accept or dismiss. Running with a design partner and in our demo workspace today.
On a deviation that is under investigation, when a person asks for it:
Every item is a draft in a side panel until a person accepts it and applies it.
You can see what the AI did
When AI drafts a deviation investigation, the record keeps which version of the model wrote it and what it was asked. When a person accepts or dismisses part of that draft, that is recorded too, with the reason they gave. Both sit in the same sealed history as every other action, and both name who — or what — acted.
We measured it before we switched it on
Before enabling it anywhere, we ran the assistant against past deviations where the right answer was already known. Our bar was 75% on severity and on whether a CAPA is warranted. It scored 100% on both, on 12 August 2026. That was ten cases, and we will always tell you that.
The record proves who acted and that a person decided. It does not prove the AI was right — that judgement stays yours.
09 · COMPLIANCE ARCHITECTURE
Compliance built into the foundations, not bolted on.
Invariant is built to support 21 CFR Part 11 and EU Annex 11 expectations from the database up.
Electronic signatures, a sealed audit trail, server-enforced workflows and formal change control are what everything else is built on, not features bolted onto a spreadsheet replacement.
Our own releases go through written proposals, approvals and release notes, and an update adds to your existing records rather than rewriting them.
Tamper-evident audit trail
Every change keeps who made it, when, and what the record looked like before and after, sealed to the entry before it. Edit history directly in the database and the seal breaks: the built-in verifier names the record that broke.
Electronic signatures
Wherever a record is signed off, Invariant records who signed, when, what it meant, and exactly what they were signing, and it makes them re-enter their password first.
The system enforces the rules, not your training
Steps are enforced by the server, not by remembering the SOP. You cannot approve a change control that was never submitted, and where finalization gates are switched on, completed records are locked against direct edits.
In-app alerts, when enabled
With in-app alerts enabled and the scheduled scan configured, a bell flags work that is due soon, overdue or critical across deviations, CAPAs, tasks, change controls, document reviews and training, and clears itself when the work is done.
Help, inside the app
Twelve written guides built into Invariant, searchable by title or heading, so people can look something up without leaving the screen they are on.
We prove it, repeatably
Each control on this page is backed by an automated proof we re-run on every release, and we will walk your QA team through the output.
Invariant is not certified, validated or compliant on your behalf: validating it for your intended use stays your programme’s decision, and we will walk your QA team through the evidence behind any claim on this page.
BUILT AROUND21 CFR Part 11 · EU Annex 11
10 · THE UNFAIR ADVANTAGE
Quality workflows from a team that understands production operations.
A production problem is never one team’s problem. Production and Quality investigate it together, decide together, and fix it together. Invariant gives them one shared record to do that in, with the batch or lot a problem relates to noted by the person who knows it.
One record, one place
A problem, its investigation, the decision, and the follow-up actions live on one record in one workspace.
Clear handoffs
Who owns it, when it is due, what status it is in, and who has signed are visible to everyone who should see them, on the record itself.
Linked end to end
Deviations, CAPAs, training and the audit history link to each other, so a problem and its consequences stay connected.
11 · WHO IT’S FOR
You outgrew binders. The eQMS that replaced them didn’t keep up.
CPG & nutraceuticals
Consumer packaged goods and supplement manufacturers running GMP-adjacent quality programs at scale.
Cannabis
Health Canada, EU-GMP, and Australian TGA/ODC requirements, US state-licensed manufacturers, and Metrc-adjacent traceability.
Pharma-adjacent
Contract manufacturers and regulated producers who need audit-trail rigor without an enterprise-eQMS price tag.
OPERATING ACROSSCanada · United States · Europe · Australia
SWITCHING FROM A LEGACY eQMS?
We built Invariant to be the reason you switch.
If your eQMS feels like it was designed a decade ago and priced like an ERP, that’s because it was. Teams leaving legacy quality platforms tell us the same thing: heavy configuration projects, months-long rollouts, and a UI nobody asked for.
Invariant is built so you can start using it without a six-month configuration project.
You can bring your existing documents, deviations and CAPAs in from CSV, and the screens are built for the people who actually use them.
12 · GET STARTED
See Invariant live.
Book a 30-minute demo with the team building Invariant. We’ll walk you through our live demo workspace and map it onto how your quality programme actually runs.
A live demo workspace: the closure-time dashboard, a worked deviation and CAPA, and the audit trail verified in front of you
A fit conversation about your quality program and where it is brittle
A straight answer on timeline for your team
No sales pressure, just a working call with the team building Invariant.
Not ready for a call? Watch the 3-minute film