This course provides a comprehensive introduction to the principles of GAMP® 5 and the fundamentals of Data Integrity in regulated GxP environments. Participants will gain an understanding of the computerized system lifecycle, risk-based validation concepts, software categorization, and the roles and responsibilities required to maintain compliance. The course also explores regulatory expectations for Data Integrity, including the ALCOA++ principles, electronic records, electronic signatures, and governance practices that ensure data is complete, consistent, accurate, and reliable throughout its lifecycle. Through practical examples and industry case studies, participants will learn how GAMP® 5 and Data Integrity principles work together to support patient safety, product quality, and regulatory compliance.
We deliver structured, role-specific training programs in Computer System Validation (CSV), designed to equip your team with the knowledge and skills needed to confidently manage validation activities in GxP-regulated environments.
Whether you’re onboarding new QA staff, training system owners, upskilling project managers, or enhancing the GxP knowledge of your IT team to maintain validated systems, our programs are tailored to reflect real-world responsibilities and regulatory expectations, ensuring both understanding and practical application.
We deliver structured, role-specific training programs in Computer System Validation (CSV), designed to equip your team with the knowledge and skills needed to confidently manage validation activities in GxP-regulated environments.
Whether you’re onboarding new QA staff, training system owners, upskilling project managers, or enhancing the GxP knowledge of your IT team to maintain validated systems, our programs are tailored to reflect real-world responsibilities and regulatory expectations, ensuring both understanding and practical application.
