Artificial Intelligence for GxP
Learn how Sware is investing in AI to change the future of GxP validation in life sciences
Are our target process(es) correct and would they benefit from AI?
Are our experts equipped to understand, use, and manage AI?
Have we identified the right vendor or solution for the task at hand?
Regulatory Bodies are Paying Attention
As of today, there is no specific regulatory guidance defining quality controls or validation methods specific to AI and GxP compliance. However, the conversation around AI for GxP is gaining momentum, with major regulatory bodies contributing to the conversation. These bodies include:
The Future of Life Sciences Validation is Here: Are You Ready?
At a live roundtable event held in February 2024, three leaders from industry, IT, and Quality came together in Boston to discuss the future of GxP validation, including the role AI will play and the how to prepare for its inevitable integration. Read our whitepaper based on the illuminating discussion, hosted by Bryan Ennis (Founder, Sware) and featuring speakers Nathan McBride (Senior Vice President, IT at Xilio Therapeutics) and Aryaz Zomorodi (Associate Director, Systems Quality, SpringWorks Therapeutics).
is Here: Are You Ready?
At a live roundtable event held in February 2024, three leaders from industry, IT, and Quality came together in Boston to discuss the future of GxP validation, including the role AI will play and the how to prepare for its inevitable integration. Read our whitepaper based on the illuminating discussion, hosted by Bryan Ennis (Founder, Sware) and featuring speakers Nathan McBride (Senior Vice President, IT at Xilio Therapeutics) and Aryaz Zomorodi (Associate Director, Systems Quality, SpringWorks Therapeutics).
Quality Must Play a Pivotal Role at Every Stage
Today’s consensus is that AI is both acceptable and valuable but must exist firmly within existing IT-quality control frameworks. Quality leaders must be prepared to work closely with their IT counterparts to implement GxP solutions that offer explainable, transparent AI technologies, as well as develop robust SOPs that establish parameters for effective and responsible use.
Proper data governance forms a crucial foundation for success: put simply, bad data in leads to bad data out. Using our established lens, it’s important to ask: is our data curation process up to modern standards; do we have the right people overseeing data ops; and finally, do we have the right tools in place to store and organize our data, either via warehousing or data lakes?
Webinars
As part of our commitment to supporting organizations implementing AI for GxP, Sware is proud to present the following webinars:
As AI capabilities push into GxP regulated business functions, how can Quality and IT teams partner to ensure they are properly controlled? Join us as a panel of experts walks you through emerging practices for how Life Sciences companies can integrate AI-based solutions into GxP functions responsibly.
Panelists:
Bryan Ennis, President, Sware
Jamie Hijimans, President and Strategic CTO, Global Exponential Technologies (GxT)
Michelle Vuolo, Head of Quality, Tulip Interfaces, Inc.
Madhavi Ganesan, Director, Lifesciences Advisory, KPMG
In this presentation, featured speaker Bryan Ennis, President, Sware, explores important topics that Quality and IT leaders should consider when developing an organizational path towards the use of AI within the GxP ecosystem, including:
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GxP use cases where AI is emerging
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Quality System practices for managing AI in GxP
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The role of vendors, IT and Quality in controlling GxP AI
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Investments needed to scale AI capabilities into future GxP use cases
Upcoming Events and Webinars
As part of its commitment to supporting organizations implementing AI for GxP, Sware is proud to participate in the following events and webinars:
JULY 10, 2024 / 11 AM EST
As AI capabilities push into GxP regulated business functions, how can Quality and IT teams partner to ensure they are properly controlled? Join us as a panel of experts walks you through emerging practices for how Life Sciences companies can integrate AI-based solutions into GxP functions responsibly.
Topics included:
- GxP use cases where AI is emerging
- Quality System practices for managing AI in GxP
- The role of vendors, IT and Quality in controlling GxP AI
- Investments needed to scale AI capabilities into future GxP use cases
SEPT 12, 2024 / 11:15 AM EST
As AI capabilities push into GxP regulated business functions, Quality and IT teams can partner together to ensure they are properly controlled. In this discussion, we will explore important topics that Quality and IT leaders should consider when developing an organizational path towards the use of AI within the GxP ecosystem, including:
-
GxP use cases where AI is emerging
-
Quality System practices for managing AI in GxP
-
The role of vendors, IT and Quality in controlling GxP AI
-
Investments needed to scale AI capabilities into future GxP use cases
Preparing Your Life Sciences Organization for AI in GxP
As companies assess the value of these tools for their clinical and commercial endeavors, they must ensure they have the right processes, people, and tools in place prior to making significant investments.
True GxP validation domain experts can help life sciences companies navigate the complexities and challenges born out of this emergent technology, as well as develop a roadmap for AI-based validation automation.
"Sware provided invaluable support by bringing deep industry knowledge, experience, and connections to our project. Now, when I’m sitting across the table from a large life sciences client, I can speak their language and discuss compliance knowing that as audit processes evolve, we’ll be in a strong position to evolve with them."
