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Computer System Validation Course
Master the essentials of Computer System Validation with our comprehensive course tailored for Operations professionals. Dive into regulatory frameworks like FDA 21 CFR Part 11 and GAMP 5, and learn to develop robust validation plans. Gain hands-on experience in executing and documenting tests, assessing risks, and designing test protocols. Enhance your skills in preparing validation reports, ensuring compliance, and addressing deviations. Elevate your expertise and ensure your systems meet industry standards efficiently.
- Master regulatory frameworks: Navigate FDA 21 CFR Part 11 and GAMP 5.
- Develop validation plans: Define scope, objectives, and timelines effectively.
- Execute test protocols: Conduct 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 flexible workload
certificate recognized by the MEC
What will I learn?
Master the essentials of Computer System Validation with our comprehensive course tailored for Operations professionals. Dive into regulatory frameworks like FDA 21 CFR Part 11 and GAMP 5, and learn to develop robust validation plans. Gain hands-on experience in executing and documenting tests, assessing risks, and designing test protocols. Enhance your skills in preparing validation reports, ensuring compliance, and addressing deviations. Elevate your expertise and ensure your systems meet industry standards efficiently.
Elevify advantages
Develop skills
- Master regulatory frameworks: Navigate FDA 21 CFR Part 11 and GAMP 5.
- Develop validation plans: Define scope, objectives, and timelines effectively.
- Execute test protocols: Conduct 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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