GAMP 5 Software Categories Explained | Computer System Validation (CSV) Made Simple

This video is about GAMP 5 Software Categories Explained | Computer System Validation (CSV) Made Simple Join this channel to get access to perks: https://www.youtube.com/channel/UCyWirKHfmuD9OjsyxfCCiAw/join Description: Confused about how to classify your software for validation? 🤯 In this video, we break down the GAMP 5 Software Categories to help you apply the correct validation strategy for your GxP systems. Understanding these categories is critical for a Risk-Based Approach to Computer System Validation (CSV). Whether you are in Pharma, Medical Devices, or Quality Assurance, knowing the difference between a "Configured" and a "Custom" system can save you hundreds of hours of documentation! 👇 In this video, we cover: Category 1: Infrastructure Software (The foundation). Category 3: Non-Configured Products (COTS / Run-as-is). Category 4: Configured Products (LIMS, ERP, EDMS). Category 5: Custom Applications (Bespoke code). Note: We also explain why Category 2 was removed in GAMP 5! Visit our website for more stuffs like guidelines, jobs, vacancies, SOPs, Protocols, etc. Link is : https://sites.google.com/view/pharmagyan/home https://pharmaagyan.wordpress.com #GAMP5, #ComputerSystemValidation, #CSV, #SoftwareValidation, #Pharma, #QualityAssurance, #GxP, #FDACompliance, #DataIntegrity, #ValidationEngineer, #GMP, #RegulatoryAffairs, #ISPE, #SoftwareCategories, #21CFRPart11, #LifeSciences, #AuditReadiness, #VModel, #IQOQPQ, #MedTech Hello, Friends welcome to our channel "PharmaGyan" Learn about Pharmacy, Pharmaceutical companies, regulatory guidelines, Documentation procedures, SOPs, How to videos on various operating procedures, Quality Assurance, Quality control, R&D, Pharmaceutical validation and qualification guidelines and procedures etc. #PharmaGyan