Microlearning: GAMP® Basic Principles – Information Management and Tools

Overview

The "Information Management and Tools" section of the GAMP^® Basic Principles (T45) training course introduces a modern paradigm shift from traditional document-driven system life cycles 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 lifecycle and infrastructure data. Participants learn how to manage information effectively throughout its life, including generation, review, approval, change control, and archiving. The course highlights the importance of carefully selecting and managing tools (e.g., GAMP Category 1 software), aligning record and data standards with business needs, and ensuring that information remains accessible and audit-ready throughout its retention period. By embracing automation and tool-based workflows, learners are equipped to support innovation while maintaining control and compliance in GxP environments.

• Earn 0.13 CEUs
• This course is self-paced. (Courses usually take 15 to 90 minutes to complete.)
• This course is part of the GAMP^® Basic Principles Bundle

Registration Fee

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For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View upcoming courses