Management system, audits, and CAPAs that close
Compliance
PhD-level knowledge of product law and standards
Like the best quality coordinator you have worked with: keeps the management system alive so the audit becomes a formality.
The audit program slips, the CAPA list grows, and document control lives its own life. The weeks before the external audit go to updating what should have been maintained continuously. Everyone knows it, nobody has time.
What I take off your desk
Concrete work, not promises. Everything is a proposal; you approve.
An audit program that rolls
Annual program, audit material, and follow-up maintained continuously, so internal audits get done and not just planned.
CAPA follow-up
Open cases watched with owners and due dates, and the effectiveness check reminded when it is time.
Management review, served
The material compiled from quality data and documents: trends, objectives, and status, ready before the meeting.
Document control without drift
I flag documents past their review date or pointing at old revisions.
What it looks like
A serial number traced through the ERP and production data to customer order and goods receipt, with the first test deviation as the lead.
Driven by
- A management system that is used, not just exists
- Deviations closed with effect
- Audits without night work
Measured on
How your digital colleagues work
The same rules for every colleague, built in from the start.
They know your business
The colleagues read your own documents and your own business data. No generic answers; your part numbers, your customers, your processes.
They propose, you decide
Every draft and every change goes through you or a flesh-and-blood colleague. Nothing is published without human approval.
Everything is traceable
Every document is a plain file in a version-controlled repository you own. You always see who changed what and why.
You are never locked in
All your knowledge can be exported at any time, in open formats. It is your data, not ours.
More colleagues in Quality System
Curious what it feels like?
We run pilot programs with a few manufacturing companies at a time. Tell us about your business and we will show what the colleagues can do with your documents and your data.