GAMP® Resources

Why ISPE GAMP® Supports the FDA CDRH: Case for Quality Program
Features
Why ISPE GAMP® Supports the FDA CDRH: Case for Quality Program

The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation-driven approaches.

Guidance Documents
Press Releases

ISPE GAMP RDI Guide: Data Integrity – Key Concepts Released

25 October 2018
ISPE announced the release of their latest Guide, ISPE GAMP ® RDI Good Practice Guide: Data Integrity – Key Concepts . This publication provides detailed practical guidance to support data integrity within a regulated organization. "In recent years...
Online Training course

Integrating Data Integrity within a Risk-Based approach to Compliant GxP Process Control Systems (T21)

This highly interactive classroom course describes how the GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Process Control Systems, and GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records  may be applied to achieve process control systems that are fit for intended....
Training

GAMP® Data Integrity 21 CFR Part 11, 3-Day Training Course (T50)

This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.