Computer System Validation (CSV) Mastermind: Level 2

[rlscorner]

Computer System Validation (CSV) Mastermind: Level 2
Published 10/2026
Created by CSV Mastermind
MP4 | Video: h264, 3840x2160 | Audio: AAC, 44.1 KHz, 2 Ch
Level: All Levels | Genre: eLearning | Language: English | Duration: 28 Lectures ( 4h 2m ) | Size: 6 GB

Practical CSV: validation plans, URS, risk assessment, IQ/OQ/PQ, traceability, deviations and audit readiness

What you'll learn
⚡ Scope a CSV project, define responsibilities, and draft a validation plan with user requirements and acceptance criteria.
⚡ Apply high-level risk assessment, FMEA and GAMP 5 categorization to plan risk-based validation testing.
⚡ Develop IQ, OQ and PQ protocols, execute tests, capture evidence, and link requirements through a traceability matrix.
⚡ Document deviations and CAPA, prepare validation reports, organize records, and assess audit readiness and the validated state.

Requirements
❗ Basic familiarity with computer system validation, such as CSV Mastermind Level 1 or equivalent knowledge. Access to a word processor to use the templates.

Description
Build on your CSV fundamentals and work through the documentation and execution stages of a computer system validation project. Computer System Validation (CSV) Mastermind: Level 2 follows a seven-day learning path, from project kickoff and scope through testing, closeout and audit readiness.

Across 28 lectures, you will explore how system use and regulatory impact shape a validation effort, how responsibilities are defined, and how a validation plan connects with user requirements and acceptance criteria. The course then develops the risk assessment and testing strategy, including high-level risk assessment, risk-based testing and GAMP 5 categorization.

The practical sequence continues with installation, operational and performance qualification: IQ, OQ and PQ. You will study how to draft protocols and test cases, execute tests, capture evidence and screenshots, build a traceability matrix, and support QA review and sign-off. Later sections cover deviations, CAPA, validation summary reporting, archiving, common inspector questions and maintaining the validated state.

The course includes 22 downloadable, editable Word resources attached to relevant lectures. These include validation planning and requirements templates, risk assessment resources, IQ/OQ/PQ specifications, traceability and reporting templates, plus supporting guides for related CSV topics. Use these resources alongside the lessons to practice organizing your own documentation.

This Level 2 course is intended for learners who understand basic CSV concepts, including those who have completed CSV Mastermind Level 1 or have equivalent knowledge. It is relevant to QA, validation, IT and engineering professionals developing a practical understanding of the validation lifecycle. The final section introduces advanced concepts to support your next stage of learning.

Who this course is for
⭐ QA, validation, IT and engineering professionals, and learners with CSV fundamentals who want to practice validation documentation and execution.

Homepage

Code:

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