Information Systems

GAMP® AI guidance provides a pragmatic and effective framework for achieving AI-enabled computerized systems that are fit for intended use and aligned with current regulatory expectations. This course introduces participants to the requirements for AI-enabled computerized systems and internationally recognized methods of meeting those requirements.

Overview The " Legacy Systems" section of the GAMP ® Basic Principles (T45) training course addresses the challenges and regulatory expectations surrounding operational GxP systems that lack sufficient validation or documentation. Participants learn how legacy systems arise from organizational changes to neglected validation and documentation, and why they pose compliance risks. Drawing guidance from PIC/S and EU Annex 11, the module emphasizes the need to demonstrate fitness for intended use, manage GxP risks, and maintain system control. Learners explore how to apply GAMP® 5 lifecycle…

Overview The " Data Integrity and 21 CFR Part 11" section of the GAMP ® Basic Principles (T45) training course provides a comprehensive overview of regulatory expectations for data integrity, electronic records, and electronic signatures in GxP environments. Drawing from FDA guidance, MHRA definitions, and the ISPE GAMP® Records and Data Integrity Guide, the module emphasizes the importance of complete, consistent, and accurate data throughout its lifecycle. Participants explore the scope and application of Part 11, and topics including predicate rules, audit trails, access controls, authority…

Overview The " Data Integrity and 21 CFR Part 11" section of the GAMP ® Basic Principles (T45) training course provides a comprehensive overview of regulatory expectations for data integrity, electronic records, and electronic signatures in GxP environments. Drawing from FDA guidance, MHRA definitions, and the ISPE GAMP® Records and Data Integrity Guide, the module emphasizes the importance of complete, consistent, and accurate data throughout its lifecycle. Participants explore the scope and application of Part 11, and topics including predicate rules, audit trails, access controls, authority…

Overview The " Effective and Efficient Compliance" section of the GAMP ® Basic Principles (T45) training course emphasizes strategies for achieving regulatory compliance in a streamlined, risk-based, and resource-conscious manner. Participants explore key efficiency improvements, including leveraging supplier documentation, combining specification deliverables, using automated testing tools, and minimizing unnecessary documentation. The module highlights how risk-based decision-making applies across the system lifecycle from specification and testing to operational change management and system…

Overview The " Operational Phase for GxP Regulated Systems" section of the GAMP ® Basic Principles (T45) training course focuses on the governance, control, and maintenance of computerized systems after deployment. Drawing from GAMP® 5 Second Edition, the module outlines key operational appendices covering areas such as system handover, support services, monitoring, incident management, change control, configuration management, backup and restore, business continuity, and system retirement. Participants learn to tailor operational activities to system risk and complexity, implement robust…

Overview The " Testing of GxP Computerized Systems" section of the GAMP ® Basic Principles (T45) training course provides a comprehensive overview of testing strategies across the system lifecycle, emphasizing defect detection, risk management, and fitness for intended use. Participants explore both traditional and modern testing approaches, including scripted, unscripted, exploratory, and automated testing, with guidance on selecting the most appropriate method based on system impact and risk, the testing objective, and the nature of the component under test. The section highlights the…