GxP validationthat accelerates, not constrains
Empower your teams with AI-driven validation technology and decades of domain expertise in one unified platform.
Validate AI systems with the rigor that GxP demands
AI isn’t another software update. It requires specialized approaches to ensure compliance, transparency, and continuous control.
Bridge the gap between AI innovation and GxP compliance
Life sciences leaders need AI's transformative power without compromising patient safety or regulatory confidence.
Bridge the gap between AI innovation and GxP compliance
Life sciences leaders need AI's transformative power without compromising patient safety or regulatory confidence. The old validation rules no longer apply.
AI-powered features
Custom AI assistants handle routine monitoring and flag upcoming milestones.
Turn your validation data into actionable insights that drive better decisions.
Automate risk assessment based on system criticality, eliminating subjectivity and prioritizing workloads.
Transform any on-screen process into a complete validation script.
Upload any file type to encode easily into SOPs, converting existing templates with ease.
Connect systems seamlessly for automated data flow and compliance without clicking through interfaces.
Join Bryan Ennis, Sware's Chief Quality Officer, to learn essential strategies on integrating AI into GxP environments while maintaining regulatory confidence.
30-40% faster validation across multiple sites
See how a growing biotech unified validation control and freed their teams to focus on breakthrough discoveries.
Need deeper insights into your validation processes?
Learn more about Res_Q's dashboards and reporting capabilities.
30-40% faster validation across multiple sites
See how a growing biotech unified validation control and freed their teams to focus on breakthrough discoveries.
Need deeper insights into your validation processes?
Learn more about Res_Q's dashboards and reporting capabilities.
30-40% faster validation across multiple sites
See how a growing biotech unified validation control and freed their teams to focus on breakthrough discoveries.
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
-
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
"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."
Guiding principles
Classify AI systems by type and risk level to determine appropriate validation strategies and controls.
Track AI behavior in real-time to detect drift, anomalies, and performance degradation before them impact compliance.
Ensure training data quality, lineage, and versioning meet GxP standards for auditability and reproducibility.
Document AI logic, decision-making processes, and performance metrics for regulatory confidence.
Implement triggers for revalidation when AI models evolve or performance deviates from validated state.
Define clear roles for human-in-the-loop validation, ensuring AI operates within approved boundaries.
Master the convergence of AI and quality management. Get actionable strategies for modernizing validation in the age of intelligent systems.
"The Res_Q platform has transformed how we approach validation, turning what could have been a compliance burden into a streamlined process that actually accelerates our product development. As a technology company serving life sciences, we needed a partner who understood both software innovation and GxP requirements. Sware delivered exactly that, helping us build a robust validation baseline for NOTA that positions us for growth."
Alison M | Head of Clinical Trial Solutions
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