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Life Sciences GMP: Computer System Validation – Fundamentals

NQR Code:NM-5-LS-04431-2025-V2-LSSSDC

  • Old Code: NM-5-LS-04431-2025-V2-LSSSDC

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About this Qualification

Job Description

The Computer System Validation –Fundamentals program provides foundational knowledge of Computer System Validation in the life sciences industry. Participants gain an understanding of CSV’s role in regulatory compliance, key concepts and terminologies, and global guidelines such as FDA 21 CFR Part 11, EU Annex 11, ICH Q7, and GAMP 5. The course also covers common industry gaps, types of regulatory documentation, and stepwise checklists for resource planning and CSV execution.

Eligibility Criteria

Criteria 1 Criteria 2 Experience Training Qualification
Completed 2nd year of 3-year/ 4-years UG In relevant field No Experience None
Pursuing 2nd year of 3-year/ 4-years UG In relevant field No Experience None
Pursuing 2nd Year of 2 year diploma after 12th In relevant field No Experience 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 – Fundamentals LFS/MCr-0017, v1.0 Mandatory 7.5 0.25 5