ISPE GAMP® has led the way in computerized systems best practices for more than 30 years. GAMP brought us the concept of system lifecycles and leveraged the V-model to give us a structured approach to computerized systems validation (CSV). GAMP developed and adopted the risk-based approach to CSV, enabling industry to focus validation efforts on critical systems and functionality.
IT Services: Applying Good IT Practice and Automation Cover: This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure...
In 2021, the ISPE GAMP® Community of Practice (CoP) is celebrating 30 years of promoting industry good practice for computerized systems and encouraging technical innovation and progress, while protecting patient...
Online Live Overview This Virtual course includes the new revised EU GMP Annex 11, and an update on 21 CFR Part 11. This two-day fundamental course* introduces participants to regulatory requirements for computerized...
Online Live Overview This highly interactive virtual course describes how the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems, and GAMP® RDI Good Practice Guide: Data Integrity -...
This webinar will discuss the lifecycle of computerized laboratory equipment, with some discussion of the similarities and differences to computer system validation, and the use of quality risk management to right-size...
