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A risk-based approach to compliant GxP computerized systems
Since its release in 2008, ISPE GAMP® 5 has provided essential international guidance on GxP computerized systems, validation and compliance for the pharmaceutical industry.
As technologies and processes have moved on, this internationally recognized guidance was updated in July 2022 to GAMP® 5 Second Edition, to provide updated GAMP® guidelines and support the industry’s transition from computerized system validation (CSV) to computerized system assurance (CSA).
The second edition is intended to keep IT, software engineering and automation good practices up to date with latest available technologies, services and risk-based approaches. While the main GAMP® guidelines and appendices remain relevant, some areas have been updated, and some new topics have been added.
GAMP® stands to acknowledge Good Automated Manufacturing Practice.
The GAMP® purpose is to act as a reference and help users to maintain a system that produces quality equipment using the theory of prospective validation following a life cycle model. It has been specifically designed to aid suppliers and users in the Life sciences and Pharmaceutical industries.
Developed to address evolving FDA and other regulatory agency expectations, GAMP® practices are recognized and utilized globally by many regulated companies and their suppliers, and are widely supported by regulatory agencies.
Eurotherm recognizes the transformation to modernized risk-based approaches and we’re adapting our project development, tools, templates, procedures and services to suit the agile model in compliance with the revised GAMP® 5 document.
Our GAMP® 5 engineering approach is already helping life science customers to simplify compliance.