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.
- 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 adequate FS from system vendor
- And more...
- Regulatory Managers
- Metrology Managers
- Quality Managers
- Validation Managers
- Facility Managers
- Stability Managers
- Warehouse Managers
- Laboratory Managers
- Logistics Managers
- R & D Managers
Paul Daniel is the Senior Regulatory Compliance Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 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 also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.