
See further. Move faster. Lead with confidence.
Intelligent validation brings visibility and data-driven insights to every decision, putting you ahead of tomorrow's challenges.

See further. Move faster. Lead with confidence.
Intelligent validation brings visibility and data-driven insights to every decision, putting you ahead of tomorrow's challenges.

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.
Primary Use Cases for AI in GxP
In the life sciences GxP domain, use cases include:
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Drug target identification
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Trial design and monitoring
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Content quality control (QC)
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Site selection
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Site recruitment and Retention
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Real-world data (RWD) analysis
Life Sciences Process Optimization Services
From reactive management to proactive excellence
When validation lives in spreadsheets and email chains, you can't see patterns, identify bottlenecks, or show improvement. Data-driven intelligence transforms every validation decision, turning backlogs into breakthroughs.

- 01 AI Risk Assessment
- 02 Explainable AI Controls
- 03 Model Validation Protocols
- 04 Continuous Performance Monitoring
- 05 Regulatory Intelligence
- 06 Data Integrity for AI
Right-size validation to actual risk
Not all AI carries equal risk. Our stratified approach matches validation depth to patient impact, from low-risk analytics to critical manufacturing controls.
Transparency regulators trust
Every decision is traceable. Every output is explainable. Build confidence with AI that documents its reasoning and maintains complete audit trails.
Validate AI like any GxP system
Comprehensive validation frameworks covering training data, model performance, and ongoing monitoring. Meet FDA and EMA expectations with confidence.
Validation that keeps pace with your models
Real-time performance tracking identifies model drift and data shifts. Trigger revalidation automatically when thresholds exceed acceptable limits.
Stay ahead of evolving guidance
From the FDA's AI/ML framework to EMA's computerized systems updates, we translate regulatory imperatives into practical validation strategies.
ALCOA+ principles meet machine learning
Ensure data integrity from training sets through production. Automated quality checks maintain accuracy, consistency, and compliance throughout the AI lifecycle.

Learn how to shift from project-based validation to a process-driven approach integrated with your QMS.

Use cases
Intelligent risk scoring ensures your team focuses effort where it matters most.
Quality, IT, and Manufacturing work from the same playbook from end to end, anywhere.
Real-time KPIs delivered via native dashboards show which changes drive improvement.
Identify where validation typically slows down, helping you reallocate resources.
Build custom integrations with our open API. Connect Res_Q to your tech stack – including QMS, ERP, and custom tools – for seamless data flow across global operations.
Adapt and scale across multiple sites, product lines, and regulatory requirements.

A biopharmaceutical company managing 25-30 SaaS releases per year freed three FTEs from validation work. See how they saved 102 hours per project with Res_Q and Sware.
Sware is a rare solutions provider in that it provides both disruptive technology and a team of true functional experts. Sware provides both the platform and people needed to excel at validation, saving us time and money and making our lives considerably easier.”
Director, Clinical and Development Systems
Biopharmaceutical Company

"Res_Q is an all-in-one solution that integrates seamlessly with the multitude of vendors and platforms commonly used in our industry. The platform has proven invaluable as we've scaled our operations. I highly recommend Res_Q for growing companies looking to streamline their validation processes."
Mahir K | Senior Specialist, QA Computer Systems Validation
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?

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."

