GAMP

Technological innovations in Artificial Intelligence (AI) provide new opportunities for the life sciences, and offer new ways to approach challenges in GxP regulated processes. While such approaches offer promising advancements, additional responsibilities are also introduced that require thoughtful decision-making to ensure effective use of emerging technology.

This ISPE GAMP® Guide: Artificial Intelligence is the single source for a holistic interpretation on effectively developing and using AI-enabled computerized systems in GxP areas, while safeguarding patient safety, product quality, and data integrity. It reviews existing guidance and expectations on good practices and presents additional concepts for areas not covered by guidance. Offering a robust, cost-effective approach when applied with expertise and good judgement, the framework presented in this Guide helps to ensure that AI-enabled computerized systems are of high-quality, effective, fit for their intended use, and compliant with applicable regulations. Key principles and practices relevant to the design, development, operation, and use of AI are also discussed.

The ISPE GAMP® Guide: Records and Data Integrity provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate, and available throughout their life cycle.

Maintaining the principles and framework of the First Edition, GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of service providers, evolving approaches to software development, and the more widespread use of software tools and automation. It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate approaches.