GAMP®

Basic Principles of AI-enabled Computerized Systems Compliance: Applying the GAMP® AI Guide (T77)

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....

Microlearning: GAMP® Basic Principles – Operational Phase for GxP Regulated Systems

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...

Microlearning: GAMP® Basic Principles – Computer Software Assurance (CSA)

Overview The " Computer Software Assurance (CSA)" section of the GAMP ® Basic Principles (T45) training course introduces the FDA’s evolving guidance on CSA, emphasizing a risk-based, patient-centric, and quality-focused approach to software validation and assurance. Moving away from traditional...

Microlearning: GAMP® Basic Principles – Quality Risk Management (QRM)

Overview TThe " Quality Risk Management (QRM)" section of the GAMP ® Basic Principles (T45) training course provides a structured, science-based approach to identifying, assessing, and controlling risks throughout the lifecycle of GxP computerized systems. Grounded in ICH Q9 R1 principles, the...

Microlearning: GAMP® Basic Principles – Testing of GxP Computerized Systems

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...

Microlearning: GAMP® Basic Principles – Data Integrity and 21 CFR Part 11

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...

Microlearning: GAMP® Basic Principles – Legacy Systems

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...

Microlearning: GAMP® Basic Principles – Validation and Data Integrity for Spreadsheets and End User Applications

Microlearning: GAMP® Basic Principles – Effective and Efficient Compliance

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...

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...