Early access · Compliance plan

The quality system you can hand to an inspector

An electronic quality management system (eQMS) for regulated manufacturers. Documents, training, deviations, CAPA and internal audits in one record, signed under 21 CFR Part 11 on an audit trail nobody can edit. And an AI Compliance Officer that reads the regulators so your SOPs never drift unnoticed.

  • Built to ISO 13485
  • 21 CFR Part 11
  • EU GMP
  • EU hosted
The Compliance plan, as sold today7/8
DocumentsVersioning, review, approval, effectivityIncluded
TrainingMatrices, assignment, quizzes, requalificationIncluded
DeviationsLogging, risk, investigation, dispositionIncluded
CAPAActions, owners, effectiveness reviewIncluded
Internal auditsProgramme, checklists, findings, closureIncluded
E-signatures21 CFR Part 11, soft-invalidationIncluded
Audit trailAppend-only, tenant-isolatedIncluded
AI Compliance OfficerWatches the regulators, flags drift in your SOPsGrowth plan
Compliance planEarly access open30-day trial · no cardEU hosted
The problem

Audits are not failed on the quality of your work

They are failed on whether you can prove it. The work gets done. The evidence just is not kept in a form anyone can inspect.

Fragmented

SOPs in SharePoint, approvals in email, training in a spreadsheet.

Unversioned

Nobody is sure which revision is current until someone notices it was not.

Unprovable

The record exists. The trail of who changed what, when, and on whose authority does not.

Rebuilt each audit

Weeks spent reconstructing evidence that should have been a by-product of the work.

AI Compliance Officer

A compliance officer that reads the regulators, so your SOPs never drift unnoticed

Every eQMS stores your documents. Ours watches EMA, MHRA, EUR-Lex, ICH and the harmonised-standards lists, maps each change onto your live documents, and hands QA a finding with the gap, the clause and a suggested edit. Nothing is marked compliant by a machine: the finding becomes a change request or a new version, approved by a person, on the audit trail.

Watches the sources you actually open

EMA, MHRA, EUR-Lex, EudraLex Volume 4, ICH Q-series, PIC/S, the EU harmonised and UK designated standards lists.

Finds the drift

Each regulator change is run against your controlled documents. A finding names the document, the gap, the severity and its confidence.

Never invents a clause

A citation is only shown if the text was retrieved from a source we are allowed to read for you. No retrieval, no citation.

Acts inside the record

Accept a finding and it becomes a change request or a new document version. Reject or defer it and the decision is on the trail.

Early access

Put your name to it

We are taking a small number of first customers so onboarding is done properly.

Tell us more (optional)

People who run tests or inspections, such as QC or validation testers.

We use this to contact you about access. Marketing and promotional offers are separate and only if you tick the box. No third parties.

We use analytics cookies (page views, clicks, scroll and mouse movement) to understand how visitors use this site. Nothing is tracked until you accept. See our Cookie Notice for what each cookie is for.