AI-NATIVE eQMS · REGULATED MANUFACTURING

The eQMS your inspector can verify. Not just trust.

QualityCore is the AI-native eQMS for regulated manufacturing. Every change it records is sealed to the one before it, so an inspector can verify your history instead of taking your word for it. AI drafts investigations in early access with our design partners today — and every draft it writes is on the record.

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From the team behind Elevated Signals, with years of experience supporting regulated manufacturing operations.

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. QualityCore puts it on the front page, live, with the trend and the owner of every open item — and lets you manage it: due-date targets by severity, business days on your own holidays and time zone, and a second person’s password required to extend a deadline.

QualityCore · Closure-time dashboard

4.8days

AVG CAPA/DEVIATION CLOSURE

94%

ON-TIME CLOSURE VS SLA

OVERDUE, ACTION NEEDED

OWNERS SCORECARDED

12-MONTH CLOSURE-TIME TREND (TARGET: 5 DAYS)

AGING BUCKETS · OPEN RECORDS

0–30 DAYS62%

31–60 DAYS24%

61–90 DAYS9%

90+ DAYS5%

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.

Documents

Controlled SOPs move draft → review → approved. The server refuses to skip a step, and an approved document downloads as a marked controlled copy.

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.

CAPAs

Owners, due dates and evidence. Every action completes, someone signs that it actually worked, and closing takes a signature on top of that.

Change Control

Raise a change, let affected teams comment before committee, then submit → approve → implement with a signature at each controlled step.

Training

Programmes, assignments, due dates and records. Where automated retraining is switched on, a CAPA that calls for retraining creates the assignments, and cannot close until they are signed off.

Complaints

Log against a controlled category list, link to a deviation or CAPA, attach evidence, and flag trends that warrant a corrective action.

Quality tickets & tasks

Anyone in the plant raises a quality request and follows it. QA gets a queue. Changing an owner, status or due date needs a reason.

Batch & lot context

Tag the batch or lot a deviation or CAPA relates to, with who added it and when, without disturbing a signature on the record.

Reports & audit exports

CAPA and deviation metrics to CSV or PDF, a management-review pack for any period, and an audit-trail verification report.

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.

COMPLIANCE ARCHITECTURE

Compliance built into the foundations, not bolted on.

QualityCore 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. QualityCore 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.

Tamper-evident audit trailEvery 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 signaturesWherever a record is signed off, QualityCore 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 trainingSteps 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.

Alerts before things go lateA 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 appTwelve written guides built into QualityCore, searchable by title or heading, so people can look something up without leaving the screen they are on.

We prove it, repeatablyEach 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.

BUILT AROUND21 CFR Part 11 · EU Annex 11

AI-NATIVE BY ARCHITECTURE

Everyone says they have AI. Ours leaves evidence.

Most quality systems can now generate an investigation for you. We could not find one that publicly documents what the machine actually did. QualityCore 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. 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.

LIVE TODAY

The record underneath it all

Every change QualityCore 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.

EARLY ACCESS

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.

WHAT CHECKING IT ACTUALLY LOOKS LIKE

LIVE TODAY

Anyone can say their history is trustworthy. In QualityCore 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.

The Verify Integrity check passing: chain intact, 9 records verified from genesis.

The check passing. Every record recomputed from the first one.

The same check after a past record was deliberately altered: integrity issue detected, naming record f68ff602 with the reason row_hash mismatch.

The check catching us. We altered a past record on purpose, with full database access. It stopped on record f68ff602 and gave the reason: the content no longer matches its seal.

Captured in a test workspace built for this, never against customer records. The record proves who acted and that a person decided. It does not prove the AI was right — that judgement stays yours.

Your audit trail, sealed entry by entry

0x7f3a…e21c

DEVIATION LOGGED · PERSON

0x9b1d…44f0

INVESTIGATION DRAFTED · AI

0xc228…9a71

REVIEWED, WITH A REASON · PERSON

0x1e04…6bd3

CAPA LINKED · SYSTEM

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.

WHAT THE AI DRAFTS

EARLY ACCESS

On a deviation that is under investigation, when a person asks for it:

1. A view on how serious it is, and why it thinks so
2. An assessment of what it affects
3. A 5-Whys skeleton to work through
4. Whether it thinks a corrective action is warranted, and why
5. Similar past deviations from your own organisation — when that history is available. It can come back empty.

Every item is a draft in a side panel until a person accepts it and applies it.

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. QualityCore 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.

THE PRODUCT

See QualityCore in motion.

Real screens from a live demo workspace. Not mockups.

Closure time, live

QualityCore quality dashboard with closure-time KPIs and trend charts

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. QualityCore 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.

A deviation is captured

A deviation is logged, classified by severity, and worked through a structured root-cause template.

The CAPA closes with a decision

“Retrain the team” is the most common mitigation in the industry, and the most commonly dropped.

The retraining assignments get created

Where automated retraining is switched on, set a CAPA action as retraining, name who needs it, and the assignments are created the moment that action completes.

And the CAPA can’t close until they’re done

Each person completes the training, attests to it, passes, and signs with their password. The CAPA cannot be marked done, verified as effective, or closed until every one of those is on file.

QualityCore training records auto-created from CAPA-2026-004, each carrying its source link and completion status

Example assignment records showing which CAPA each came from.

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 QualityCore 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, consultant-led rollouts, and a UI nobody asked for. QualityCore is built so you can start using it without a six-month configuration project.

No consultantsRequired to get started

You can bring your existing documents, deviations and CAPAs in from CSV, and the screens are built for the people who actually use them.

Book a demo

GET STARTED

See QualityCore live.

Book a 30-minute demo with the team building QualityCore. We’ll walk you through our live demo workspace and map it onto how your quality programme actually runs.

WHAT TO EXPECT ON THE CALL

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 QualityCore.