You're a skilled automation engineer. You know PLC logic, SCADA architecture, and how to commission a system that runs. GMP documentation is a different discipline — and most system integrators entering pharma learn it the hard way, under deadline pressure, in front of a client who knows exactly what's missing.
QLean Automation gives you the framework to deliver like you've done this before — because we built it from the experience of having done it ourselves.
Your firm does solid industrial automation — food & bev, manufacturing, utilities. You know your way around a cabinet. Now a pharma client is asking for a Validation Plan, FAT protocol, and Traceability Matrix by end of next month. You've heard of GAMP 5. You're not entirely sure what Category 4 means for your document scope. You don't want your client to realise this is your first time.
A Tier 1 integrator brought you in for the automation work. They're managing the client relationship. You're responsible for a compliant validation package that goes straight to the end client's QA team without rework. You've done pharma projects before — but you built the documents from scratch each time. You're not doing that again.
A growing suite of documentation tools for automation engineers and system integrators working in GMP-regulated pharmaceutical environments.
25+ production-ready IQ/OQ/PQ templates for PLC/SCADA systems. Full V-Model lifecycle, embedded guidance notes, pre-linked traceability. Covers every document your pharma client expects.
102-page engineering reference covering GAMP 5 2nd Edition, 21 CFR Part 11, EU Annex 11, and PLC/SCADA architecture for GxP environments. Written for engineers, not auditors.
An AI-powered documentation engine that generates GAMP 5-compliant first drafts from your system inputs. Structured within the same regulatory framework as the template library — not a generic AI tool.
The GAMP 5 V-Model is a dependency chain. URS requirements trace through FDS, SDS, HDS into IQ, OQ, and PQ test cases. The framework catches gaps before your client's QA team does.
Every template includes embedded guidance notes — not just blank fields. Each section explains what it needs to contain and why, based on what regulators actually look for. No compliance background needed.
The Validation Plan includes a Software Categorisation section that drives your entire document scope. The framework tells you exactly what applies — so you never over-document a Category 3 system or leave a gap on a Category 5.
Every file is .docx or .xlsx. No proprietary software, no platform to log into. Works in Word and Excel, versions in your existing document control system, submits in the format your clients already expect.
Use the GAMP 5 Software Categorisation guide to assign Cat 1, 3, 4, or 5. This single decision determines exactly which documents your project requires.
Open the relevant .docx and .xlsx files. Pre-populated with real PLC/SCADA examples and embedded guidance in every section.
The Traceability Matrix links URS requirements through FDS to IQ, OQ, and PQ test cases. Gaps highlighted automatically before your client sees them.
Run qualification confidently. Deviations go into the MDL, changes through the CCL. The Validation Summary Report closes the package cleanly.
Deep engineering guides on GAMP 5, 21 CFR Part 11, PLC/SCADA validation, instrumentation, and data integrity. Written for engineers who build systems, not compliance consultants.
The category you assign drives your entire document scope. Get this wrong and you either over-document a simple COTS system or leave a dangerous gap on a custom application. A practical guide to making the right call.
Read article →What Part 11 actually requires from your SCADA historian, audit trail configuration, and electronic signature implementation. Covers open vs closed system classifications and what inspectors look for.
Read article →What each qualification phase actually tests, how to write test cases that pass QA review, and the most common gaps that cause rework. Real examples from PLC and SCADA automation projects.
Read article →Two ways to get value before you spend a penny — a readiness assessment and two reference tools.
42 questions across 6 capability domains. Pinpoints your gaps before a pharma client does — and matches you to the right articles from our knowledge base.
Take the Readiness Check →A single licence covers your entire company — no per-seat fees, no per-project fees, no expiry. Buy once, use across every pharma project your team runs.
An SI billing at €600–900/day spends 3–5 days building docs from scratch — €1,800–4,500 of billable time, every project. The Framework costs €249 once. The first project pays it back 8×.
The engineering masterclass — for engineers who want to understand the regulatory framework before or alongside the full pack.
Everything — the complete template library and the masterclass that explains every document you'll produce.
The complete template library — for experienced engineers who need the documents without the background theory.
QLean Automation was built by automation engineers with 10+ years of hands-on PLC/SCADA validation experience in GMP-regulated pharmaceutical environments.
We've delivered validation packages as system integrators and had them reviewed by pharma QA teams. We're not compliance consultants. We're engineers who solved a documentation problem and built tools around the solution.
Unsure whether the framework fits your project type — Ignition, Siemens TIA Portal, AVEVA, Rockwell, custom HMI? Get in touch before you buy. We're happy to answer technical questions.
The documentation framework is ready. The regulatory structure is in place. You bring the engineering — we've done the compliance groundwork.
Get the Full Framework — €249 →// Instant download · Company-wide licence · Standard .docx + .xlsx · No subscription