Lessons Learned from Validating a Cloud-based IRT system using the GAMP 5 Risk-based Approach

This presentation will include a discussion of the actual process followed and highlight the portions of the GAMP 5 framework that made it possible to validate a cloud-based IRT and outline the use of best practices from GAMP 5 for managing a risk-based validation process. The presentation will outline risks that were identified as specific to software as software as a service, cloud hosting models, and server virtualization, and discuss mitigation plans. Understand the difference between public and private cloud architectures, identify risks that are inherent in using software as a service, and identify benefits of cloud-based computer systems.