In this webinar you will learn how to validate software in alignment with GAMP principles, including how to develop a URS Document, a Traceability Matrix, and more...
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 will describe how to validate software according to GAMP5. Included are several tools for ensuring your monitoring system validation aligns with the ISPE's guidelines.
What you will learn:
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:
How to create a Functional Specification (FS) Document (FSD), or obtain an adequte FS from system vendor
R & D Managers