How to Validate System Software According to GAMP Principles

System validation according to GAMP
Industrial Manufacturing and Processes
Life Science

Environmental monitoring systems are considered an "automated system” by the Good Automated Manufacturing Practice (GAMP) guidelines published by the International Society for Pharmaceutical Engineering (ISPE). These guidelines were created to help firms in GxP-regulated industries ensure function and compliance of software and computerized systems. 

In this webinar, Vaisala's Senior Regulatory Compliance Expert Paul Daniel  describes how to validate monitoring system software according to best practices outlined in GAMP5. Included are several tools for ensuring your monitoring system validation aligns with the ISPE's guidelines.

 

Topics covered: 

 

  • How to develop a User Requirements Specification (URS) Document
  • Steps to creating a Traceability Matrix
  • Three different types of software systems and their validation processes: Off-the-Shelf, Configured, Custom
  • How to create a Functional Specification Document (FSD), or obtain an adequate FS from a system vendor
  • And more...

Target Audience

  •     Regulatory Managers
  •     Metrology Managers
  •     Quality Managers
  •     Validation Managers
  •     Facility Managers
  •     Stability Managers
  •     Warehouse Managers
  •     Laboratory Managers
  •     Logistics Managers
  •     R & D Managers

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Webinar speaker

Paul Daniel, Vaisala

Senior GxP Regulatory Compliance Expert

Paul Daniel has worked in the GMP-regulated industries for over 25 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects.  His specialties include mapping, monitoring, and computerized systems.  At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system.  He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications.  Paul is a graduate of University of California, Berkeley, with a bachelor’s degree in biology.

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