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Computer System Validation Course
Master the fundamentals of Computer System Validation with our complete course specifically designed for Operations professionals. Dive deep into regulatory frameworks such as FDA 21 CFR Part 11 and GAMP 5, and learn how to develop solid validation plans. Get practical experience in carrying out and recording tests, assessing risks, and creating test protocols. Improve your skills in preparing validation reports, making sure of compliance, and dealing with deviations. Increase your expertise and make sure your systems meet industry standards effectively.
- Master regulatory frameworks: Navigate FDA 21 CFR Part 11 and GAMP 5.
- Develop validation plans: Clearly define the scope, objectives, and timelines.
- Execute test protocols: Conduct and record functional, security, and performance tests.
- Assess risks: Identify, record, and lessen possible system validation risks.
- Prepare validation reports: Ensure compliance and present results clearly and concisely.

from 4 to 360h flexible workload
certificate recognized by MEC
What will I learn?
Master the fundamentals of Computer System Validation with our complete course specifically designed for Operations professionals. Dive deep into regulatory frameworks such as FDA 21 CFR Part 11 and GAMP 5, and learn how to develop solid validation plans. Get practical experience in carrying out and recording tests, assessing risks, and creating test protocols. Improve your skills in preparing validation reports, making sure of compliance, and dealing with deviations. Increase your expertise and make sure your systems meet industry standards effectively.
Elevify advantages
Develop skills
- Master regulatory frameworks: Navigate FDA 21 CFR Part 11 and GAMP 5.
- Develop validation plans: Clearly define the scope, objectives, and timelines.
- Execute test protocols: Conduct and record functional, security, and performance tests.
- Assess risks: Identify, record, and lessen possible system validation risks.
- Prepare validation reports: Ensure compliance and present results clearly and concisely.
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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