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Computer System Validation Course
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.
- 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.

flexible workload from 4 to 360h
certificate recognized by MEC
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.
Elevify advantages
Develop skills
- 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
Before starting, you can change the chapters and workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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