GAMP® Resources

GAMP

GAMP Guide: Records & Data Integrity

Published: March 2017 Pages: 152 Table of Contents Special Pricing for Emerging Economies The ISPE GAMP ® Guide: Records and Data Integrity provides principles and practical guidance on meeting current expectations for the management of GxP regulated
GAMP Good Practice Guides

GAMP RDI Good Practice Guide: Data Integrity by Design

Published: October 2020 Pages: 176 Table of Contents Special Pricing for Emerging Economies Data Integrity by Design is the concept that data integrity must be incorporated from the initial planning of a business process through to the implementation
GAMP Good Practice Guides

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

Published: October 2018 Pages: 196 Table of Contents Special Pricing for Emerging Economies The ISPE GAMP ® RDI Good Practice Guide: Data Integrity – Key Concepts provides detailed practical guidance to support data integrity within a regulated
GAMP Good Practice Guides

ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records

The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them.
GAMP Good Practice Guides

GAMP Good Practice Guide: Manufacturing Execution Systems

Published: February 2010 Pages: 144 Table of Contents Special Pricing for Emerging Economies The ISPE GAMP ® Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach uses a complete lifecycle approach to the
GAMP Good Practice Guides

GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition

Published: February 2011 Pages: 196 Table of Contents Special Pricing for Emerging Economies The GAMP ® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision of the GAMP ® Good Practice Guide: Validation of Process
GAMP Good Practice Guides

GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition

Published: February 2017 Pages: 164 Table of Contents Special Pricing for Emerging Economies As organizations find themselves operating from multiple sites worldwide, with groups and departments split between multiple geographies, or even using third
GAMP Good Practice Guides

GAMP Good Practice Guide: Operation of GxP Computerized Systems

Published: January 2010 Pages: 216 Table of Contents Special Pricing for Emerging Economies During the operational life of a GxP system, regulators usually focus on the integrity, consistency, and completeness of controls required to maintain
Training

GAMP® Data Integrity 21 CFR Part 11 2-Day Training Course (T70)

The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result....
New GAMP SIG Explores Computer Software Assurance
iSpeak Blog
New GAMP SIG Explores Computer Software Assurance

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.