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2021 ISPE Annual Meeting & Expo

Concurrent Session: GAMP® 5 - Critical Thinking, Agile Methods, and IT Infrastructure Control


Nov 1, 2021 3:00pm ‐ Nov 1, 2021 4:30pm


Description

Concurrent Session: GAMP® 5 - Critical Thinking, Agile Methods, and IT Infrastructure Control|This session will focus on how the GAMP® 5 model is evolving to adapt to the current changes in digitalization.  The topics in this session include: Understanding the flexibility of GAMP® 5, that Agile does demonstrate control and how records or tools can be used in place of documentation. Critical Thinking is a mindset that must be applied when implementing GAMP® 5 to ensure that a risk-based approach to quality and compliance takes account of the multiple layers of assurance that may exist upstream or downstream of the system within the business process it supports. The use of Good IT Practices, electronic IT Service Management Tools and Automation as an effective means of achieving continuous compliance of the IT infrastructure environment including cloud and on premise.

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