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SOLUTIONS

GxP validationthat accelerates, not constrains

Empower your teams with AI-driven validation technology and decades of domain expertise in one unified platform.

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PROCESS OPTIMIZATION

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.

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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.

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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:

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  

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.

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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.

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WHITE PAPER
Process over projects: Rethinking GxP system validation

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

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Use cases

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Risk-based prioritization

Intelligent risk scoring ensures your team focuses effort where it matters most.

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Cross-functional workflows

Quality, IT, and Manufacturing work from the same playbook from end to end, anywhere.

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Performance insights

Real-time KPIs delivered via native dashboards show which changes drive improvement.

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Issue identification

Identify where validation typically slows down, helping you reallocate resources.

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Enterprise API

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.

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Global scalability

Adapt and scale across multiple sites, product lines, and regulatory requirements.

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CASE STUDY
102 hours per project saved

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.

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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

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"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

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Explore more solutions

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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Succeed today. Optimize for tomorrow.

We'll assess your current state and position you to seize tomorrow's opportunities.