Computer system validation

Computer validation is more than a compliance requirement. It not only reduces regulatory risk, but it also increases understanding of system during project implementation and enforces a structured, well-defined execution of the project. Pharmaceutical computer system validation is a unique opportunity for a business to examine their computer systems to maximize effectiveness and enhance quality, with the potential to save cost and time. Subject matter expert (SME) of CSV will have a major role in achieving these benefits. This course will be of benefit to anyone involved in FDA audits and Computer Systems Validation (CSV) on both a domestic and global scale.  Additionally, this course will be highly-relevant to those in Quality Assurance, Compliance, Validation, Informatics, Procurement, R&D, Commercial, Quality Control and other job functions which are impacted by CSV efforts.  This course is particularly useful to those who interface with vendors, FDA and other regulatory agencies.

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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

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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

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Following Live Projects will be teach to candidates 

• Data Acquisition System (DAS)

• Chromatographic Data System (CDS)

• Packing US-Serialization System