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Life Sciences GMP: Computer System Validation - Lifecycle & Risk Assessment

NQR Code:NM-5.5-LS-04432-2025-V2-LSSSDC

  • Old Code: NM-5.5-LS-04432-2025-V2-LSSSDC

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About this Qualification

Job Description

The Computer System Validation (CSV) Lifecycle and Risk Assessment Program equips life sciences professionals with essential knowledge and practical skills to navigate the validation lifecycle using risk-based methodologies. Covering key stages like URS, FRS, DQ, IQ, OQ, and PQ, the program ensures compliance with FDA 21 CFR Part 11 and EU Annex 11. It emphasizes high-level risk assessments with tools like FMEA and Risk Assessment Matrices to enhance system integrity and validation outcomes. With hands-on training in validation planning, test execution, and risk assessment on systems like LIMS, participants gain practical expertise to master CSV processes effectively.

Eligibility Criteria

Criteria 1 Criteria 2 Experience Training Qualification
UG In relevant field No Experience None
Pursuing 3rd year of 3-year/ 4-years UG In relevant field No Experience None
2 year Diploma after 12th Completed 1 year None

Progression Pathway

  • Not Available

Learning Module In Job Role/Qualifcation

National Occupation Standards (NOS)/Module NOS Code Mandatory/ Optional Estimated size (Hours) Nos Credit Level
Life Sciences GMP: Computer System Validation - Lifecycle & Risk Assessment LFS/MCr-0021 Mandatory 7.5 0.25 5.5