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

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 organised

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.

Your review could appear here. Take the course as an early-access learner and tell others what it gave you.

Reserved for our first learners

We won't fill this space with made-up praise. Real feedback from real learners will land here after launch.

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.

Block 1 — Foundations · 3 modules
Validation in the pharmaceutical industry
Key concepts and terminology
The system life cycle

Block 2 — Concept phase · 2 modules
Building the business case
System selection

Block 3 — Risk and planning · 5 modules
Validation governance
Risk management
Supplier assessment
Validation planning
Software and hardware categories

Block 4 — Project setup · 3 modules
Responsibility split
Change and configuration management
IT infrastructure

Block 5 — Specification and design · 3 modules
Requirements
Configured systems
Custom applications

Block 6 — Testing and release · 3 modules
Testing strategy
Test execution
Report and release

Block 7 — Data integrity · 3 modules
Data integrity fundamentals
Data integrity by design
Spreadsheets and end-user applications

Block 8 — Operations · 8 modules
Handover
Service management
Incidents and CAPA
Change and patch management
Periodic review
Backup and business continuity
Security and administration
Records and archiving

Block 9 — Retirement · 2 modules
System retirement
Data migration

Block 10 — Cross-cutting topics · 2 modules
Agile development
Emerging technology

Bonus modules · 3 modules
Electronic batch records
Organisational change
Legacy systems

Learning programs

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, e-mail and a password. Nothing to pay, nothing to cancel.

How much does it cost?

The course isn't on sale yet, so there's no price on the site. It goes up on launch day, end of September 2026. People on the waitlist see it first and get the early-access offer, so if price is what decides it for you, sign up at csvonline.eu/waitlist.

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 from 20+ years of validation work.

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, at foundation level. You'll know what each one asks of you and why: access control, audit trail, data integrity, change management. It won't turn you into a Part 11 specialist. It gives you enough to apply the requirements with confidence and to know when a question needs a specialist.

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 an offer together for the team. If you want to see the material first, the free preview module is at csvonline.eu/waitlist.

Built by the founder of GAMP Poland

Smart Validation sp. z o.o.
ul Grzybowska 87, 00-844 Warszawa