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Follwing Topics will be covered as Minimum as part of CSV Course:- 


  • Module 1: Software Validation & Infrastructure Qualification

  • Module 2: Computer System Validation (CSV) - Overview, Regulatory requirements (GAMP & 21 CFR Part 11) and documentation

  • Module 3: High Level Risk Assessment (GxP Assessment, Software Categorization as per GAMP 5, ERES Assessment)

  • Module 4: GAMP 5 and documentation (URS, FS, DS, CS, Source Code Review Report, Validation Plan, Validation Report, Test Plan & Test Summary Report)

  • Module 5: Testing of Computerized System (IQ, OQ, PQ, UAT, Regression Testing, Smoke Testing, Sanity Testing)

  • Module 6: Penetration Testing (Threat Modeling, SAST & DAST)

  • Module 7: Excel Sheet Validation 

  • Module 8: Cloud Computing (SaaS, PaaS, IaaS)

  • Module 9: Software Development Life Cycle (SDLC) : Waterfall, V-Model, Agile Methodology, DevOps etc.

  • Module 10: Back-up and Restore, Archival & Retrieval of Data

  • Module 11: Business Continuity Management

  • Module 12: System Retirement & Data Migration

  • Module 13: Quality Management System and Quality Risk Management 

  • Module 14: Computer Software Assurance (CSA Approach), A New way of working for CSV

Following Live Projects will be teach to candidates 

  • Data Acquisition System (DAS)

  • Chromatographic Data System (CDS)

  • Packing US-Serialization System 




Graduation/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.


Upon Successful completion of Course our team will provide Following

  • Resume Preparation 

  • Interview Preparation and Mock Interview Session.

  • Communication skills and personality development sessions

  • Placement Assistance

Computerized System Validation Course

SKU: 364215376135191
Excluding Sales Tax
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