Computer System Validation Course
This course equips you with essential skills for Computer System Validation in LIMS and GxP environments. You will master risk-based validation approaches, data integrity principles, compliance with Part 11 and Annex 11 regulations, effective testing strategies, and robust change control processes. These competencies enable you to design, validate, and maintain compliant, audit-ready systems suitable for modern technology landscapes, ensuring reliable and secure operations in regulated industries.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
Gain practical expertise in planning, executing, and maintaining compliant LIMS environments through this Computer System Validation Course. You will learn to draft clear user requirements, conduct risk assessments, establish traceability, create test protocols, and handle change management effectively. Additionally, master critical areas like data integrity, audit trails, electronic signatures, and major US/EU GxP regulations to ensure your systems remain inspection-ready and support secure, dependable operations.
Elevify advantages
Develop skills
- Develop skills in risk-based LIMS requirements to write testable URS, FS, DS with clear traceability.
- Gain expertise in CSV lifecycle planning by applying GAMP 5 and ALCOA+ for lean, compliant projects.
- Learn test design for LIMS systems, including building IQ/OQ/PQ and high-risk cases for cloud setups.
- Master data integrity controls such as audit trails, e-signatures, and secure access management.
- Acquire proficiency in change and incident control, managing releases, CAPA, and periodic GxP reviews.
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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