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Computer System Validation Course

What will I learn?

Learn the key things about Computer System Validation with our detailed course specifically made for Operations professionals. Go deep into the rules and regulations like FDA 21 CFR Part 11 and GAMP 5, and learn how to make strong validation plans. Get real experience in doing and writing down tests, looking at risks, and creating test protocols. Improve your skills in preparing validation reports, making sure you follow the rules, and dealing with things that go wrong. Improve your knowledge and make sure your systems meet the industry standards well.

Apoia's Unique Features

Online and lifetime access to courses
Certificate aligned with educational standards
PDF summaries for easy printing
Online support available at all times
Select and arrange the chapters you want to study
Set your own course workload
Instant feedback on practical activities
Study at your convenience, no internet required

Develop skills

Strengthen the development of the practical skills listed below

Learn the rules well: Understand FDA 21 CFR Part 11 and GAMP 5 properly.

Make validation plans: Decide the scope, what you want to achieve, and the deadlines clearly.

Do test protocols: Carry out and write down functional, security, and performance tests properly.

Look at risks: Find, write down, and reduce possible risks in system validation.

Prepare validation reports: Make sure you follow the rules and show clear and easy-to-understand results.

Suggested summary

Workload: between 4 and 360 hours

Before starting, you can change the chapters and the workload.

  • Choose which chapter to start with
  • Add or remove chapters
  • Increase or decrease the course workload

Examples of chapters you can add

You will be able to generate more chapters like the examples below

This is a free course, focused on personal and professional development. It is not equivalent to a technical, undergraduate, or postgraduate course, but offers practical and relevant knowledge for your professional journey.