About QLean Automation

Precision engineering
for pharmaceutical
compliance.

We bridge the gap between industrial automation and the documentation demands of GMP-regulated facilities. Built by engineers who have actually been on the other side of a QA audit.

Our Story

Engineers who got
tired of starting over.

QLean Automation was founded to solve a problem we lived ourselves. After a decade working in control systems engineering across GMP-regulated pharmaceutical environments, we recognised a pattern: engineers rebuilding the same validation documents from scratch on every engagement, under deadline pressure, without a reliable reference for what "good" actually looked like from a QA perspective.

We have navigated the full GAMP 5 lifecycle from URS through IQ/OQ/PQ to Validation Summary Report, and we understand both sides of the equation — what the automation system needs to do, and what the documentation needs to demonstrate. That dual understanding is the foundation for everything we publish.

We built QLean because the tools we wished had existed when we started simply didn't. The framework is not assembled from regulatory text. It is structured around how qualification actually plays out in the field — the sections that get challenged, the gaps that cause rework, and the formats that QA teams can work with efficiently.

The documents that pass QA aren't the ones written by compliance experts. They're the ones written by engineers who understood both what the system does and what the regulation requires — and built the bridge between them.

// QLean Automation · Founding Principle

What sets us apart
  • → Templates structured around how QA panels actually evaluate documentation — not assembled from regulatory clauses alone
  • → Full GAMP 5 2nd Edition (2022) alignment — not the outdated 2008 framework still circulating online
  • → 100+ free technical articles sharing the knowledge that usually stays locked inside consulting firms
  • → Standard editable file formats — no platform, no subscription, no lock-in
Our Principles

Three commitments we
don't compromise on.

// Principle 01
🔓
The Open Toolkit Philosophy

We do not believe in recurring licences, proprietary file formats, or platform dependencies. Every document we sell is a standard editable file that you own outright — adaptable to any project, storable in any document control system, usable by every engineer in your firm, forever. One purchase. No expiry. No strings.

Standard .docx + .xlsx · Company-wide licence · No subscription
// Principle 02
📚
Free Knowledge for the Automation Community

Our 100+ article knowledge base is permanently free and ungated. No email required, no premium tier, no teaser content. We publish detailed, technical engineering guides on GAMP 5, 21 CFR Part 11, data integrity, PLC/SCADA validation, and instrumentation — because a better-informed engineering community produces better-validated systems. Full stop.

100+ articles · No paywall · Always free
// Principle 03
⚙️
Grounded in Field Knowledge

Every template and article is structured around how validation actually runs in the field — the sections QA teams scrutinise most closely, the gaps that consistently cause rework, and the document formats that hold up under audit. Nothing here was assembled purely from regulatory text. It is written by engineers who understand what the system does and what the documentation needs to demonstrate.

10+ years GMP engineering experience · GAMP 5 2nd Ed.
Knowledge Base

100+ free articles.
No paywall. No login.

Technical guides written for engineers entering pharmaceutical automation — not compliance summaries aimed at managers.

GAMP 5
GAMP 5 Software Categories: How to Classify Your System Correctly

Category assignment drives your entire document scope. A practical guide to making the right call on Category 3, 4, and 5 systems.

Data Integrity
21 CFR Part 11: Audit Trails and Electronic Records for SCADA Systems

What Part 11 actually requires from your SCADA historian, audit trail configuration, and what inspectors check first.

Qualification
IQ, OQ, PQ: A Practical Guide for PLC and SCADA Engineers

How each phase differs, how to write test cases that pass QA review, and the gaps that most commonly cause rework.

Validation Lifecycle
The V-Model in Pharmaceutical Validation: A Systems Engineer's View

Why the V-Model exists, how it maps design documents to qualification tests, and what it means for your traceability architecture.

Browse all 100+ articles →
Our Commitment

Pass audits.
Reduce lead times.
Own your documentation.

Our mission is to give automation engineering teams the toolkit to deliver compliant validation packages with confidence — without rebuilding the same documents from scratch on every project, without recurring licence costs, and without needing a compliance consultant to explain what to write.

Get the GAMP 5 Framework → Browse Knowledge Base