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GAMP Microlearning: Information Management and Tools

GAMP® Microlearning: Information Management and Tools

ISPE has created mirolearning offerings based on the GAMP® Basic Principles (T45) training course.  This section focuses on Information Management and Tools. The "Information Management and Tools" section of the GAMP® Basic Principles (T45) training course introduces a modern paradigm shift from traditional document-driven validation to dynamic, tool-based information management. Emphasizing efficiency, data integrity, and regulatory compliance, the module explores how tools—such as JIRA, Confluence, GitHub, and CMDBs—can serve as secure, searchable repositories for validation and infrastructure data. Participants learn how to manage information effectively across its lifecycle, including generation, review, approval, change control, and archiving. The course highlights the importance of qualifying tools (as GAMP Category 1 software), aligning documentation standards with business needs, and ensuring that information remains accessible and audit-ready. By embracing automation and tool-based workflows, learners are equipped to support innovation while maintaining control and compliance in GxP environments.
165.00