Sware, Inc., a provider of AI-powered validation and GxP compliance solutions, today announced the launch of Res_Q Connect, the first AI-validated MCP integration platform for GxP-regulated organizations. Res_Q Connect is a governed integration layer that connects the Sware Res_Q platform to the regulated systems life sciences organizations already run — including QMS, ERP, and other enterprise platforms — without requiring custom, point-to-point scripts.
Res_Q Connect is built on an open Model Context Protocol (MCP) standard. Users describe a desired outcome in plain language, and Res_Q Connect configures the corresponding automation for review and approval — logging every action automatically to produce a complete, 21 CFR Part 11-ready audit trail.
“Every regulated company we work with is solving the same problem the same way — their teams are the connective tissue between systems, moving data by hand because nothing built for this industry has done it for them,” said Ellen Reilly, CEO of Sware. “Res_Q Connect changes that by putting AI to work on the manual moves, while keeping people in control of every decision. Our customers get their time back without compromising audit readiness. That’s the combination regulated teams have needed for a long time.”
Res_Q Connect is designed to help regulated organizations:
- Reclaim time: Eliminate manual work between systems so validation and quality teams can focus on higher-value, judgment-driven tasks.
- Maintain schedule integrity: Automatically track and action overdue tasks, periodic reviews, and SOP renewals.
- Extend visibility: Give internal teams, partners, and auditors the right update at the right moment, without requiring a login.
- Strengthen audit readiness: Record every automated and manual action in an immutable, Part 11-ready trail.
Built for IT and enterprise architecture teams, Res_Q Connect replaces one-off, point-to-point integrations with a single standardized framework that governs how systems exchange data and trigger actions inside a structured, reviewable model. The platform is designed to scale as organizations add new systems and use cases, without re-architecting existing integrations.
“Our architecture already includes QMS, ERP, and a growing number of specialized platforms,” said an IT director from a Top 10 Pharma Company. “Res_Q Connect meets that complexity with a governed standard instead of another script to maintain — and it does that within the same system we are already using, just at scale.”
Res_Q Connect is available now, with full production capabilities rolling out through Q4 2026. To learn more or get started, reach out to the Sware team at sware.com.
About Sware
Sware is the company behind Res_Q, the intelligent GxP validation platform that empowers life sciences leaders to see further and navigate rapid technological change with confidence. By integrating agentic AI frameworks with deep human expertise, Res_Q unifies workflows, uncovers operational insights, and ensures every decision is explainable, traceable, and reversible. Backed by Sware’s leadership team, with over two decades of solving complex compliance challenges, the platform enables Quality, IT, and Digital Transformation leaders to spend less time on admin work and accelerate mission-critical results. Learn more at sware.com.
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