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The complete CSV training, built on GAMP 5 by the founder of GAMP Poland.

A full computerised system validation course for pharma, biotech and medical-device teams. 
Open now. You can take the free preview lesson before you buy.
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Computerized system validation, explained in full

A complete online course in computerised system validation, built on GAMP 5 and taught in English. It brings the whole field into one place and in the right order — for people who work with computerised systems in pharma, biotech and medical devices.

Genuinely self-paced

No live dates, no set schedule. Watch each lesson when it suits you, pause when you need to, and repeat anything until it clicks. The course fits around a full-time job or a career move.

No camera, no pressure

You're never on screen and never put on the spot. Learn privately, at your own speed — no keeping up with a room, no awkward questions in front of others.

Complete and organized

The whole of CSV in one place and in a logical order — not scattered across clips, threads and slides. You finish with a course completion certificate from Smart Validation Academy.
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Smart Validation Academy

What you'll be able to do

Understand what CSV really is

Know what computerised system validation is, why it exists and where it fits — so the work stops feeling like box-ticking and starts making sense.

Work the risk-based way

Apply a risk-based approach aligned with GAMP 5, and place your work inside the EU regulatory frame set by Annex 11 (EU GMP).

Validate in proportion to risk

Scope validation to the risk that actually matters — effort where it counts, not documentation for its own sake. Skills you can put to work the next day.

Course program

Block 0 — Welcome to Pharma World · 1 module 
Welcome to Pharma World 

Block 1 — Foundations · 2 modules
Key Concepts 
Life Cycle Approach and Critical Thinking 

Block 2 — Concept phase · 2 modules
Concept Phase —Business Case and User Needs
Concept Phase — System Selection

Block 3 — Risk and planning · 5 modules
Compliance Governance
Quality Risk Management
Supplier Assessment
Validation Planning
Software and Hardware Categories

Block 4 — Project setup · 3 modules
Responsibility Split
Project Change and Configuration Management
IT Infrastructure

Block 5 — Specification and design · 3 modules
Specifying Requirements
Configured Systems (Cat. 4)
Custom Applications (Cat. 5) — Design Review & Traceability Matrix

Block 6 — Testing and release · 3 modules
Testing Strategy
Test Execution and Deviation Management
Validation Report and System Release

Block 7 — Data integrity · 3 modules
Data Integrity Fundamentals
Data Integrity by Design and the Audit Trail
Spreadsheets and End User Applications

Block 8 — Operations · 8 modules
Handover to Operation
Service Management and Monitoring
Incidents, Problem Management and CAPA
Operational Change and Configuration Management
Periodic Review
Backup, Restore, and Business Continuity
Security and System Administration
Records Management and Archiving

Block 9 — Retirement · 2 modules
Retirement and Decommissioning
Data Migration

Block 10 — Cross-cutting topics · 2 modules
Agile Software Development and Validation Tooling
Emerging Technologies

Block 11 — Additional Topics · 3 modules
Electronic Production Records
Organizational Change
Legacy Systems Validation

CSV Foundations follows a computerized system from the first business need through to its retirement. The course is built on GAMP 5, Records and Data Integrity, and international regulations including FDA 21 CFR Part 11, CSA, EU Annex 11 and Chapter 4 — and ordered the way the work happens on a real project.
You buy the CSV Foundations course as a Package of 37 modules: 34 in 11 blocks (Block 0 to Block 10), plus 3 bonus modules. On the day of purchase, we make all blocks available when your access opens.

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Other Courses

Created by Rafał Buczek

Built by the founder of GAMP Poland

Before you sign up

Can I see the course before I pay?

Yes. Sign up at csvonline.eu/waitlist and the free module Software Categories — Free Preview opens immediately. It's a real lesson, taught the same way as the course itself, not a trailer. You create a free account — first name, last name, email and a password. Nothing to pay, nothing to cancel.

How much does it cost?

€449, all taxes included, for orders paid by the end of 30 October, Polish time. You pay once for 12 months of access, with no subscription and no renewal.

I've never done validation. Will I be lost?

No. The course starts at the beginning, with the five GAMP 5 principles and the system life cycle, before it goes anywhere advanced. You need no prior validation experience and no preparation. If you already work in validation, the value is in the order and in what the second edition of GAMP 5 changed.

Will I be able to do the work afterwards?

You come out with the method: how to judge risk, what to test, how to document it. The examples are real situations, like the legacy system with no documentation or the weekend go-live. How far you take it from there depends on your own projects. Rafał Buczek, founder of GAMP Poland, built the course on 20+ years in computerized system validation.

How long does it take?

Modules run from 20 to 75 minutes each. The whole course is roughly 14 hours. You set the pace, so it can be a couple of weeks of evenings or three months of lunch breaks.

Does it cover 21 CFR Part 11, Annex 11 (EU GMP) and CSA?

Yes. Part 11 and Annex 11 come up in modules across the course, from the basics to how they apply on a real validation project. The course explains what each one asks of you and why: access control, audit trail, data integrity, change management. CSA is FDA guidance for software used in medical device production and quality systems. The course introduces it in the Key Concepts module and uses its critical-thinking approach in later modules. It won't turn you into a Part 11 specialist, and some questions on your own systems will still need one.

What kind of certificate is it?

You finish with a course completion certificate from Smart Validation Academy, issued once you pass the final exam. It confirms you completed the course and passed. It isn't an accreditation and we don't claim anyone else's endorsement for it.

What isn't in the course?

It isn't a full GMP course or a course in pharmaceutical law. It isn't a technical manual for validating AI or blockchain either; it shows how the risk-based approach applies to those and stops there. Data integrity is covered to the depth validation needs, not as a course in its own right. If that's what you came for, better to know now than after you pay.

Can you train my team?

Yes. Write to kontakt@smartvalidation.pl and we'll put a quote together for the team. If you want to see the material first, the free preview module is at csvonline.eu/waitlist.

Ready to start from the ground up?

The course is open. You get 12 months of access and set the pace yourself.
Po polsku: opis kursu — smartvalidation.pl/kurs-csv, Regulamin — csvonline.eu/terms
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ul Grzybowska 87, 00-844 Warszawa
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GAMP® is a registered trademark of ISPE. Smart Validation sp. z o.o. is an independent training provider. It is not affiliated with, endorsed by, accredited by or certified by ISPE, the FDA, EMA, PIC/S or the European Commission, and this course is not an official course of any of them.
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