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SOLUTIONS

GxP validationthat accelerates, not constrains

Empower your teams with AI-powered validation technology and decades of life sciences expertise in one unified platform.

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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

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  
SOFTWARE VALIDATION

Keep pace with rapid release cycles

Move beyond document-heavy validation. Manage continuous software updates while maintaining audit readiness at innovation speed.

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PROCESS OPTIMIZATION

Turn compliance data into better processes

Surface hidden insights from unified validation data. Transform boxes to check into opportunities for excellence.

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Validation Automation

Automation with accountability built in

Custom AI agents encode your best practices and scale without limits. Every decision remains explainable, traceable, and reversible.

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CASE STUDY
30-40% faster validation across multiple production sites

See how a growing biotech unified validation control and freed their teams to focus on breakthrough discoveries.

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Res_Q has saved us significant time and resources, allowing us to focus on core business objectives. I wholeheartedly recommend Res_Q to fellow industry professionals.”

Senior Director, IT Business Partner, GxP Systems
Biotechnology Company

CASE STUDY

30-40% faster validation across multiple sites

See how a growing biotech unified validation control and freed their teams to focus on breakthrough discoveries.
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ONE-SHEET

Need deeper insights into your validation processes?

Learn more about Res_Q's dashboards and reporting capabilities.

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CASE STUDY

30-40% faster validation across multiple sites

See how a growing biotech unified validation control and freed their teams to focus on breakthrough discoveries.
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ONE-SHEET

Need deeper insights into your validation processes?

Learn more about Res_Q's dashboards and reporting capabilities.

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CASE STUDY

30-40% faster validation across multiple sites

See how a growing biotech unified validation control and freed their teams to focus on breakthrough discoveries.

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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).

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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).

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?

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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:

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GxP AI: How Quality Systems Can Responsibly Control AI to Enhance Productivity and Streamline Operations

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

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Building Quality Into GxP AI: How Quality Systems Can Responsibly Control AI

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:

  • 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

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:

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.

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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
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VALIDATE AI FOR GXP

Purpose-built AI that puts trust first

Harness intelligent technology designed for life sciences complexity. Stay transparent, traceable, and ready for the most rigorous scrutiny.

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PLANT & EQUIPMENT VALIDATION

Equipment validation without the complexity

Unify equipment records, calibration tracking, and change management in one AI-powered platform. Scale validation across your global ecosystem.

GXP FOR DEVELOPERS

Speed and compliancewithout compromise

Integrate validation directly into your development pipeline. Ship faster without compromising quality or regulatory requirements.

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Ready to embrace the future of life sciences compliance?

Talk to an expert to build your roadmap for continued success.