Computer System Validation (CSV) is a critical process in the pharmaceutical and life sciences industry that ensures computerized systems are reliable, secure, and compliant with regulatory requirements such as FDA 21 CFR Part 11 and global regulatory guidelines. CSV helps organizations verify that software, equipment, and automated processes consistently perform according to their intended use.

Our Computer System Validation Training Course is designed to provide professionals with in-depth knowledge of validation principles, regulatory expectations, and practical implementation strategies used in pharmaceutical and healthcare industries. The program focuses on industry-relevant methodologies that help organizations reduce compliance risks, improve system quality, and ensure accurate data integrity.

This Online CSV Training Program is ideal for professionals working in Quality Assurance (QA), Quality Control (QC), Compliance, Validation, IT, Regulatory Affairs, Clinical Research, and Pharmaceutical Manufacturing. The course also benefits individuals who interact with vendors, regulatory agencies, and FDA auditors during system validation and inspection processes.

​

Course modules

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 Spreadsheet Validation

Module 8 -  Cloud Computing (IaaS, PaaS, SaaS)

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

Module 15 - URS / FRS / PRS / SRS
Module 16 - Source Code Review Report (Live Understanding)
Module 17 - Infrastructure Qualification (Physical & Cloud)
Module 18 - Software Testing Lifecycle (STLC)
Module 19 - System or Software Categorization Checklist
Module 20 - Test Management Tools (Live Hands-on Experience)
Module 21 - Defect Management Tools (Live Hands-on Experience)
Module 22 - Test Summary Report and Validation Summary Report
Module 23 - Validation Deliverables (Cat 3, 4 & 5) (Live Hands-on Experience on Software)
Module 24 - Operation / Maintenance of Software
Module 25 - Periodic Review of Software
Module 26 - Decommissioning of Software
Module 27 - Data Migration
Module 28 - GAMP 5 Guideline
Module 29 - PLC Validation

​

Advance Topics

Module 30 - Virtual Machine (VM)
Module 31 - DevOps Structure
Module 32- Deployment / Delivery / Hosting (CI/CD Approach)
Module 33 - Disaster Recovery and Business Continuity & IT Resilience Plan
Module 34 - GAMP-5 Comparison between 1st and 2nd Version
Module 35 - Artificial Intelligence & its Validation Approach
Module 36 - Excel Spreadsheet Validation
Module 37 - Data Integrity (Data Integrity Checklist)
Module 38 - Software Designing (Database, Backend & Front End)
Module 39 - Cloud Computing (IaaS, PaaS, SaaS)
Module 40 - Computer Software Assurance (CSA)
Module 41 - Agile Project & Sprint Creation (Agile & SCRUM Certification)
Module 42- GAMP-5 Comparison between 1st and 2nd Version
Module 43 - Infrastructure as Code
Module 44 - Different IT Terminologies

​

Following Live Projects will be teach to candidates 

• Data Acquisition System (DAS)

• Chromatographic Data System (CDS)

• Packing US-Serialization System