GAMP 5: a risk-based approach to GxP-compliant IT systems. Second edition

validacion sistemas informatizados gamp 5

GAMP5 Revision 2, known as GAMP® 5 Second Edition, is a deep update that reflects current technological changes and regulatory trends, focusing on patient safety, product quality and data integrity in the use of computerized systems in regulated environments in sectors such as pharmaceuticals or the medical device sector. This edition is significant for its adaptation to modern software development practices and emerging technologies, offering essential guidance for the pharmaceutical, medical device and related industries.

One of the most notable novelties of this edition is its recognition of non-linear software development methods, such as agile and iterative models, which mark a change from traditional linear approaches. This change responds to the need for flexibility and efficiency in the development and validation of computerized systems, allowing faster adaptation to changing project needs.

Critical thinking takes a central role in GAMP® 5 Second Edition, emphasizing the importance of applying objective analysis and evaluation to make informed decisions throughout the life cycle of computerized systems. This approach seeks to optimize validation and quality assurance processes, moving beyond compliance with minimum regulatory requirements towards more robust and efficient systems.

Another important innovation is the recommended use of appropriate tools and systems for documentation and information management. This approach not only improves the organization and accessibility of information but also responds to the evolution towards more digital and automated work environments.

The edition also promotes innovation by updating terminology and adding new appendices on emerging technologies such as blockchain and artificial intelligence/machine learning (AI/ML). These changes reflect the rapid evolution of technology and its impact on the industry, underscoring the need for a framework that allows innovations to be incorporated safely and effectively.

The transition from emphasis on computer system validation (CSV) to computer system assurance (CSA), with a risk-based approach, is another significant change. This approach seeks greater efficiency and effectiveness in quality and compliance management, moving away from practices based exclusively on compliance and extensive documentation.

Finally, the introduction of the concept of unscripted testing complements standard testing and more effectively challenges systems, allowing a more complete evaluation of their operation and reliability. This approach aligns with the trend toward more flexible and adaptive practices in the development and validation of computerized systems.

The GAMP5 Second Edition is a reflection of the industry’s evolution towards more agile, efficient and risk-based practices, always maintaining a focus on patient safety, product quality and data integrity.