Learn computer system validation step by step, in plain English

CSV 101 is a self-paced, 15-module course in computer system validation (CSV), included in your Compval membership.

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Computer validation is hard to learn on your own

The regulations are dense, the guidance is scattered, and most training assumes you already know the vocabulary. If you are moving into computer validation, or you have been handed a system to validate without a clear starting point, it is hard to know what matters and what order to do things in.

What CSV 101 is

CSV 101 is a practical walkthrough of the complete computer system validation lifecycle, from classification and risk assessment through to testing, reporting, closure, operations, retirement and internal audit. It is written and delivered by a working CSV consultant, drawing on real, current project experience rather than theory alone.

What you get

  • Nearly 5 hours of narrated video across 15 modules, self-paced, with built-in progress tracking. Come back to any module at any time during your membership.
  • A short quiz for each module, so you can check what you have taken in.
  • A certificate when you complete the course. Complete all 15 modules and score 85% or more on each module quiz to earn it. Anyone can verify it online.
  • The course manual to keep alongside the modules.
  • A library of templates and SOPs you can use in your own work.
  • Ask Iain, a service where you can put your questions to the course author.
  • Articles and case studies, and a monthly newsletter.

What you will learn

Foundations

  1. GMP and the life science industry
  2. Typical life science computer systems
  3. What is computer systems validation?
  4. GAMP 5: a risk-based approach
  5. 21 CFR Part 11: electronic records and signatures

Planning and building

  1. Validation planning
  2. Specifications: URS, FS and design specs
  3. Design Qualification (DQ)
  4. Configuring and building your system

Testing and release

  1. Verification and testing: IQ, OQ and PQ
  2. Reporting and closure

Running and retiring systems

  1. System operations
  2. System retirement
  3. CSA: Computer Software Assurance
  4. Internal audit, self-inspection and management review

Who it is for

  • Validation, QA and system-owner professionals who want a clear, practical refresher or a consistent way of working.
  • People moving into computer validation who need the whole lifecycle explained from the beginning, with acronyms spelled out.

Not sure where your system stands first? Try the free GxP Readiness Planner to see where you are today and which modules cover your gaps.

Who teaches it

Iain Littlejohn, owner and principal computer validation consultant at Compval, working across the UK and Asia. Iain is an engineer with more than 35 years in industry, from aerospace through manufacturing automation to computer system validation in life sciences. His projects range from establishing validation programmes at new greenfield sites to remediating existing sites after regulatory inspections. CSV 101 is built from that experience.

Price

Founding member: US$75 or EUR 69 a year. For the first 50 members, locked for life for as long as you stay a member.
Individual membership: US$149 or EUR 139 a year once the founding places are taken.

Membership is for one year. You choose your currency when you pay, and it stays the same at renewal. No VAT charged.

Training a team? See team memberships.

Questions

How long does it take? Nearly 5 hours of video, plus a quiz for each module. It is self-paced, so you decide when and how fast.

How long do I have access? Your membership runs for a year, and you can work through CSV 101 at your own pace during that time. When the year ends, access to the course and the member resources ends unless you renew. The certificate you have earned is yours to keep, and anyone can still verify it online. Download your certificate before your membership ends.

What is the certificate? A Compval certificate of completion that shows you finished the course. It can be verified online. It is not an accredited qualification and is not issued or recognised by a regulator.

What do I need to do to earn it? Complete all 15 modules and score 85% or more on each module quiz.

Does the course guarantee compliance? No. It teaches a practical, risk-based approach to computer system validation. Your own quality system and your inspectors decide what is acceptable for your organisation.

Can you train my whole team? Yes. See team memberships, or email admin@compval.com for custom training tailored to your systems and processes.

Ready to start?

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