The Need for AI Guidance
Members of the GAMP Community of Practice (CoP) Software Automation (SA) and Artificial Intelligence (AI) Special Interest Group (SIG) have collaborated and consistently produced guidance to support practical implementation of AI-enabled computerized systems since 2019. After GPT-3 was released, leaders of the GAMP SA and AI SIG were inundated with questions from ISPE members. Witnessing a rise in concern and seeing the growing set of challenges industry colleagues were facing, the leaders agreed that it was time to create a GAMP Guide about AI to aid companies in the efficient and effective implementation of AI-enabled computerized systems. Life science professionals around the world shared their concerns and expressed their fears as they struggled to understand technology and sought guidance. Only a limited number of pioneers within industry and ISPE were collaborating on AI topics, many from the GAMP CoP. The members of the GAMP SA and AI SIG representing this group of pioneers were flooded with questions asking how, if at all, AI could be validated. Reflecting on these discussions, recurring themes and key challenges emerged including:
- Knowledge management: The need for building new AI literacy skills
- Evolving regulatory expectations: Regulatory uncertainty from a lack of clear guidance
- Suppler relationships: A lack of common language and understanding of responsibilities
- Speed of technology innovation: Facing an accelerating influx of ideas and technology, challenging organizational capabilities
- Risk management: Uncertainty in determining an appropriate control strategy by lack of technology understanding
- Data: Often fragmented, collected and structured for its intended purpose that may not be fit for the purpose of AI development
- Cybersecurity: New cybersecurity threats aiming to exploit the dependency on data and complexity of models
- Legal considerations: Connecting the wider legislative landscape, including cross-sector AI regulation and established statues, e.g., concerned with data privacy
As a result of these challenges, too many AI initiatives have been failing or stopping at pilot stages. The failure rate of AI projects is estimated at 80%, which is considerably higher than general IT projects 10 years ago. These projects originating from a need or an opportunity aim for tangible benefits, such as: higher efficiency in helping to manage increasing workloads, improved support for patients through AI-enabled devices, better process control and yield increase in pharmaceutical manufacturing. Each project failure in these areas is not only a loss of investment resources, but in many cases has consequences for patients. The same is true for AI-enabled systems in operation that lack robustness, reliability, and control. It was time for a change.
Action was needed. The GAMP SA and AI SIG kicked off the GAMP AI Guide initiative to create the ISPE GAMP Guide: Artificial Intelligence. Recently published, this new GAMP Guide addresses challenges posed by AI-enabled computerized systems in the pharmaceutical and medical device industries.
About the Guide
The ISPE GAMP Guide: Artificial Intelligence provides a cost-effective best practice framework that aids in ensuring AI-enabled computerized systems are of high-quality, effective, fit for intended use, and comply with relevant regulations. It is meant to facilitate a common understanding of the possibilities and limitations for the use of AI within the GxP regulated industry. It serves as a reference point for a diverse set of stakeholders, including regulated companies, suppliers, service providers, and regulators, regarding the best practices in developing, implementing, and using AI-enabled computerized systems. Its primary focus is on quality and compliance and is meant for enabling innovation in environments where patient safety, product quality, and data integrity are of highest importance, in compliance with applicable regulations. The Guide addresses topics from managerial and organizational to more technical aspects.
Users of the Guide can harness various business benefits:
- Facilitating risk-based approaches in conjunction with enabling innovation to allow for focusing efforts and improving efficiency while achieving compliance
- Supporting organizations in choosing system designs that fit the organization's overall maturity and level of experience
- Having a common language to support collaboration across diverse stakeholders as a key factor in improving successful implementation of AI-enabled computerized systems
- Establishing an effective monitoring and maintenance strategy, while demonstrating ongoing control
- Facilitating continual improvement during operation, particularly by using newly generated data
Having a common, agreed-upon framework, provided by the ISPE GAMP Guide: Artificial Intelligence, can enable the industry to streamline processes in the design, implementation, and use of AI-enabled computerized systems. In the same manner, industry will be able to maintain patient safety, boost efficiencies by means of reasonable risk-based approaches, apply critical thinking, and allow for opportunities for continual improvement.
This Guide is useful to a broad set of stakeholders, including:
- GxP regulated companies (e.g., in the areas of pharmaceuticals, biologics, advanced therapy medicinal products, or medical devices)
- Suppliers (e.g., equipment, hardware, and software)
- Service providers (e.g., contract research organizations, contract development and manufacturing organizations, contract testing laboratories or specialty laboratories)
- Consultancies supporting other organizations in the design, implementation, and use of AI-enabled computerized systems
Further interested parties include academia and healthcare service providers, as much as they are or may be involved in regulated activities, or those simply aiming to protect patient safety, product quality, and data integrity in their own capacities. Similar considerations on the use of the guidance apply to stakeholders concerned in earlier research, not seen as part of GxP regulated areas.
Additional stakeholders, such as regulators and healthcare authorities, may also take advantage of the Guide as a reference point for the industry’s perspective on best practices for AI. In providing a holistic overview to achieve high-quality AI-enabled computerized systems in GxP regulated areas, the Guide can be seen as an industry response to recent discussion and reflection papers published by regulatory agencies and health authorities, including:
Alignment with Established Guidance and Standards
The new Guide bridges the general concepts of ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) with the characteristics of AI, expanding on considerations provided in Appendix D11 in GAMP 5 (Second Edition) to achieve a holistic framework. Further guidance such as ISPE GAMP® Guide: Records and Data Integrity, and the ISPE GAMP® RDI Good Practice Guide: Data Integrity - Manufacturing Records have been incorporated in the new ISPE GAMP Artificial Intelligence Guide. The Guide considers current industry regulation and guidance as well as available standards and frameworks, such as ISO/IEC 42001:2023.
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