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Computer System Validation Course
Master the fundamentals of Computer System Validation with our detailed course designed for Operations professionals. Deep dive into regulatory guidelines such as FDA 21 CFR Part 11 and GAMP 5, and learn to create strong validation plans. Get practical experience in performing and recording tests, evaluating risks, and designing test protocols. Improve your abilities in writing validation reports, ensuring regulatory compliance, and handling deviations. Enhance your expertise and ensure your systems efficiently meet industry standards.
- Master regulatory guidelines: Navigate FDA 21 CFR Part 11 and GAMP 5.
- Develop validation plans: Clearly define scope, objectives, and timelines.
- Execute test protocols: Perform and document functional, security, and performance tests.
- Assess risks: Identify, record, and mitigate potential system validation risks.
- Prepare validation reports: Ensure regulatory compliance and present clear, concise findings.

flexible workload of 4 to 360h
certificate recognized by MEC
What will I learn?
Master the fundamentals of Computer System Validation with our detailed course designed for Operations professionals. Deep dive into regulatory guidelines such as FDA 21 CFR Part 11 and GAMP 5, and learn to create strong validation plans. Get practical experience in performing and recording tests, evaluating risks, and designing test protocols. Improve your abilities in writing validation reports, ensuring regulatory compliance, and handling deviations. Enhance your expertise and ensure your systems efficiently meet industry standards.
Elevify advantages
Develop skills
- Master regulatory guidelines: Navigate FDA 21 CFR Part 11 and GAMP 5.
- Develop validation plans: Clearly define scope, objectives, and timelines.
- Execute test protocols: Perform and document functional, security, and performance tests.
- Assess risks: Identify, record, and mitigate potential system validation risks.
- Prepare validation reports: Ensure regulatory compliance and present clear, concise findings.
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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