GAMP Guide: Artificial Intelligence
Published: July 2025
Pages: 290
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.
Regulated companies, suppliers, service providers, and regulators will benefit from this Guide as It covers regulated company activities following the AI-enabled computerized system life cycle, and defines activities and responsibilities expected of both internal and external suppliers of AI products and services. The approach discussed is suitable for all types of computerized systems using AI, applicable to standard and configurable products as well as custom applications.
Benefits of adopting approaches described in this Guide include:
- Focusing on risk-based efforts to allow for efficient, compliant processes
- Choice of system designs that fit the organization’s experience
- Improved collaboration among stakeholders and between regulated companies and suppliers
- Effective monitoring and maintenance, demonstrating ongoing control of complex AI-enabled computerized systems
- Facilitating continual improvement of AI-enabled computerized systems during operation
This Guide is intended as a stand-alone Guide designed to be used in parallel with ISPE GAMP® 5 (Second Edition) and other Guides in the ISPE GAMP® Guide Series.
Guide Core Team
For the full list of contributors to this Guide see Guidance Document Teams