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Artificial Intelligence for GxP

Learn how Sware is investing in AI to change the future of GxP validation in life sciences

The Critical Importance of Data, Quality, and Collaboration

As part of its mission to implement artificial intelligence (AI) in a strategic and responsible way, Sware is working closely with leaders in IT and Quality to build a framework for robust data management, risk management, and close collaboration between IT and Quality teams.

Bringing Together Process, People, and Tools

Life sciences companies are in deep analysis mode, looking for specific use cases where AI models can enhance productivity, reduce costs, and control risk. Creating a successful technology transition strategy requires a deep understanding of how the Process, People, and Tools come together to deliver measurable results.

Questions that life sciences companies should be asking: 

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Process

Are our target process(es) correct and would they benefit from AI?

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People

Are our experts equipped to understand, use, and manage AI?

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Tools

Have we identified the right vendor or solution for the task at hand?

Primary Use Cases for AI in GxP

In the life sciences GxP domain, use cases include:

Drug Discovery

  • Drug target identification

  
Clinical Trial Management

  • Trial design and monitoring

  • Content quality control (QC)

  • Site selection

  • Site recruitment and Retention

  • Real-world data (RWD) analysis

  
Manufacturing & Supply Chain  
Regulatory & Safety  
Quality Management  
Information Technology  

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:

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WHITEPAPER

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).

Download Now
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WHITEPAPER
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).

Download Now

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?

SWR_Res-Q-Features_Illustrations_Workflow-Automation_1300x900

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?

Emerging Use Cases for AI in GxP

Drug Discovery

  • Drug target identification
Clinical Trial Management

  • Trial design and monitoring

  • Content quality control (QC)

  • Site selection

  • Site recruitment and Retention

  • Real-world data (RWD) analysis
Manufacturing & Supply Chain

  • Batch management

  • Inventory management

  • Cold-chain distribution

  • Predictive monitoring
Regulatory & Safety

  • Submissions management

  • Registration tracking

  • Literature references

  • Post-Marketing safety surveillance
Quality Management

  • Content creation

  • Process automation

  • Quality control
Information Technology (IT)

  • Data security

  • Data integrity assessments

Learn how Sware is investing in AI to change how GxP validation is managed and executed

Upcoming Events & Webinars

As part of our commitment to supporting organizations implementing AI for GxP, Sware is proud to participate in the following events and webinars:

WEBINAR
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GxP AI: How Quality Systems Can Responsibly Control AI to Enhance Productivity and Streamline Operations
AVAILABLE TO WATCH ON-DEMAND

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

WATCH ON-DEMAND
CONFERENCE
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Building Quality Into GxP AI: How Quality Systems Can Responsibly Control AI
SEPT 12, 2024  /  11:15 AM EST
BOSTON, MA

In this presentation, featured speaker Bryan Ennis, President, Sware, 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

Register Now

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:

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REGISTER NOW
WEBINARGxP AI: How Quality Systems Can Responsibly Control AI to Enhance Productivity and Streamline Operations

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
REGISTER NOW
SWR_5th-GxP-Cloud-Compliance-Summit_1200x840
Register Now
EVENTBuilding Quality Into GxP AI: How Quality Systems Can Responsibly Control AI

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

Register Now

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.

AdobeStock_432104404_web

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.

AdobeStock_432104404_web

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"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."
Jason Siegrist Chief Information Security Officer
Read the Case Study
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