How to Validate System Software According to GAMP Principles

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.

Use GAMP to Validate CMS, Vaisala Infographic 3.57 MB

Using the ISPE’s GAMP Methodology to Validate Environmental Monitoring System Software1017.37 KB

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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