GxP validationthat accelerates, not constrains
Empower your teams with AI-driven validation technology and decades of domain expertise in one unified platform.
Validate software with intelligence, insight, and assurance
Res_Q transforms months of validation work into days of focused execution, helping you validate systems faster without compromising on quality.
System validation that works the way you do
Res_Q transforms months of validation work into days of focused execution, helping you validate systems faster while improving quality.
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.
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Download our guide to modernizing computer system validation. Learn practical strategies for reducing validation timelines while improving quality.
Use cases
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Transition from traditional CSV to modern CSA. Focus validation efforts where risk truly exists while meeting FDA's latest guidance.
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Manage multiple parallel changes in GxP and non-GxP systems via automated impact assessment.
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Live in harmony with QMS; increase automation and validation oversight for continuous compliance.
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Validate development platforms, data lakes, and reporting systems. Help your business integrate, scale, and accelerate.
Validate AI and machine learning systems with specialized workflows. Address model drift, training data integrity, and continuous learning while maintaining compliance.
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Ensure constant inspection readiness for mission-critical trials with adaptive workflows.
A growing biotech reduced validation time by 40% while managing multiple sites. See how they went from manual file exchanges to one point of control and source of truth.
Res–Q has saved us significant time and resources, allowing us to focus on core business objectives and reducing validation time by 30-40%.”
Senior Director, IT Business Partner, GxP Systems
Biotechnology Company
"Res_Q has transformed our ability to manage CSV/CSA deliverables electronically, supporting our workforce both in-office and remotely. Its intuitive design simplifies configuration and evolves with our needs, while enabling seamless traceability by connecting information previously stored in paper documents.”
Daryn B | Senior Director, Head of IT
"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
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Explore more solutions
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
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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
"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."
