GAMP Guide: Artificial Intelligence

GAMP

Digital

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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

Brandi Stockton
Founder | Managing Partner
The Triality Group, LLC
Lead
Martin Heitmann
Consultant
The Triality Group
Co-Lead
Eric Staib
Vice President, Corporate Quality
Syneos Health
Co-Lead
Taylor Chartier
CEO
Modicus Prime
Joanne Donald
Global Computerized Systems Strategy Lead (CSS)
Roche Products Ltd
Stephen Ferrell
Chief Strategy Officer
Valkit.Ai
Carsten Jasper
Senior Director, Manufacturing R&D
Charles River Laboratories Inc
Michael Martone
VP Quality & Compliance
Apprentice.Io
Stefan Münch
Vice President Validation & Qualification
Körber Pharma Consulting GmbH
Meher Muttanapalli
Senior Manager, Product Quality - Software Quality
Intuitive Surgical Inc
Raj Nandhan
Director QA & Compliance
Medocity Inc
Mohammed Rahman
Director, Global Quality Solutions
OPDC
Laila Rasmy
Assistant Professor
UTHealth SBMI
Tomos Williams
CTO: Chief Technical Officer
Manchester Imaging Ltd

For the full list of contributors to this Guide see Guidance Document Teams