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Computer System Validation Course
Master the key principles of Computer System Validation with our comprehensive course designed for Operations professionals. Delve into regulatory frameworks like FDA 21 CFR Part 11 and GAMP 5, and learn how to develop solid validation plans. Get practical experience in carrying out and documenting tests, evaluating risks, and designing test protocols. Improve your skills in preparing validation reports, ensuring compliance, and handling deviations. Enhance your expertise and make sure your systems meet industry standards efficiently.
- Master regulatory frameworks: Understand FDA 21 CFR Part 11 and GAMP 5.
- Develop validation plans: Define scope, objectives, and timelines effectively.
- Execute test protocols: Carry out and document functional, security, and performance tests.
- Assess risks: Identify, document, and mitigate potential system validation risks.
- Prepare validation reports: Ensure compliance and present clear, concise results.

4 to 360 hours of flexible workload
certificate recognized by the Ministry of Education
What Will I Learn?
Master the key principles of Computer System Validation with our comprehensive course designed for Operations professionals. Delve into regulatory frameworks like FDA 21 CFR Part 11 and GAMP 5, and learn how to develop solid validation plans. Get practical experience in carrying out and documenting tests, evaluating risks, and designing test protocols. Improve your skills in preparing validation reports, ensuring compliance, and handling deviations. Enhance your expertise and make sure your systems meet industry standards efficiently.
Elevify Advantages
Develop Skills
- Master regulatory frameworks: Understand FDA 21 CFR Part 11 and GAMP 5.
- Develop validation plans: Define scope, objectives, and timelines effectively.
- Execute test protocols: Carry out and document functional, security, and performance tests.
- Assess risks: Identify, document, and mitigate potential system validation risks.
- Prepare validation reports: Ensure compliance and present clear, concise results.
Suggested Summary
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.What our students say
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