Business and GxP compliant solutions, services by Sarjen Business and GxP compliant solutions, services by Sarjen
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      • Doqstack – Digital Transformation of CSV process
      • Process Digitization; Process Automation: Platforms
      • Automation Tools
      • StackTrack; Intelligent File Tracker
      • HForce; Self Service Employee Portal
Business and GxP compliant solutions, services by Sarjen
  • Company
    • About Us
    • Corporate Maxim
    • Resources and Downloads
    • Careers
      • Equal opportunities
  • Technologies
    • Web Design/Frontend
    • Mobile Development
    • Programming/Scripting
    • Databases
    • Practices/Platforms
    • Cloud/Infrastructure
  • Digital Transformation
    • Services
    • Consulting
    • Industry Focus
  • Solutions
    • Supply Chain and SD
      • Sales and Distribution
      • Purchase and Inventory Management
      • Forecasting and Demand Planning
      • Warehouse Management
      • Distributor Management System
      • Order Processing Automation
      • Gross to Net
    • Sales Force and CRM
      • Sales Force Automation and Excellence
      • Field Sales Information
      • eDetailing System
      • Customer Order Management
      • Field Service Procurement
      • Field Training and Recruitment
      • Field Personal Assistant
    • Enterprise Quality Management
      • Quality Process Control
      • Document Control and SOP Management
      • Document Issuance
      • Training and eLearning
      • Audit Management
      • Vendor Qualification
      • APQR/PQR (Product Quality Review)
    • Digitization of Clinical Research
      • Smart Trial Suite – Early Phase
      • Smart Trial Suite – Late Phase
      • Smart Trial Suite – Oncology Trials
      • Randomization and Investigational Product Supply Management
      • Bioanalytical Laboratory Automation
      • Electronic Trial Master File (eTMF)
    • Dossier and Document Management
      • eCTD publishing and submission lifecycle
      • CTD/Paper Submission Software
      • Regulatory Information Management
      • Query Management
      • eCTD viewer
    • Pharmacovigilance Safety Database
      • Human Pharmacovigilance Safety Database
      • Veterinary Vigilance
      • Product Inquiry Trail and Response
      • EV Triage and Inbox
      • PV Literature Intake
      • PV Quality Management
      • PV Document Management
      • PV Gateway Connect
      • PV Academic Training
    • Manufacturing
      • Electronic Batch Records (EBR or EBMR)
      • Weighing and Dispensing
      • Equipment Logbook
      • Continuous Process Verification
      • Device Data Decoder
    • Others
      • Doqstack – Digital Transformation of CSV process
      • Process Digitization; Process Automation: Platforms
      • Automation Tools
      • StackTrack; Intelligent File Tracker
      • HForce; Self Service Employee Portal
Software Validation
_ June 15, 2015_ Shilpa Desai_ 0 Comments

What is Software Validation?

As per US FDA’s 21 CFR Part 11 compliance requirements, software validation is a key task. And a lot of material is available over the net on this topic. But my take on software validation is something like this…

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