Certificate in Computer System Validation

Computer system validation is more than a compliance requirement. Computer system validation in pharma not only reduces regulatory risk, but also increases understanding of systems during project implementation and enforces a structured, well-defined execution of projects. Computer system validation in the pharmaceutical industry is a unique opportunity for a business to examine its computer systems to maximize effectiveness and enhance quality, with the potential to save cost and time. Subject matter experts (SME) in CSV computerized system validation play a major role in achieving these benefits. This computerized system validation training course will benefit anyone involved in FDA audits and Computer Systems Validation (CSV) on both domestic and global scales. It is ideal for professionals in Quality Assurance, Compliance, Validation, Informatics, Procurement, R&D, Commercial, and Quality Control impacted by CSV pharma / pharma CSV activities. This CSV course online is especially useful for those interfacing with vendors, FDA, and regulatory agencies and aligns with CSV Certification Courses standards.

​

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 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

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 Sheet 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