Indianapolis, IN – September 29, 2025 — 8:00 AM Eastern Time - CAI, a global leader in operational readiness and excellence for life sciences and mission critical facilities, today announced a strategic partnership with Valkit.ai, a fast-growing innovator in AI-augmented digital validation. Together, the companies will deliver intelligent, tech-enabled solutions that transform compliance and validation processes across highly regulated environments.

The partnership unites CAI’s elite expertise in commissioning, qualification, and regulatory consulting with the Valkit.ai Gen2 intelligent validation platform designed specifically for GxP environments. This collaboration empowers life sciences organizations to accelerate time-to-market, reduce compliance risk, and increase operational efficiency by embedding AI directly into critical validation workflows such as Commissioning & Qualification (C&Q), Computer System Validation (CSV), and Computer Software Assurance (CSA).

“This partnership marks a pivotal moment in how we support our clients in regulated industries,” said Sheena Dempsey, CEO of CAI. “By aligning with Valkit.ai, we’re expanding our digital enablement toolkit with purpose-built, AI-powered solutions that automate complexity and drive smarter, faster validation. It’s a natural extension of our mission to deliver accelerated readiness and operational excellence at the highest standard.”

Valkit.ai’s platform leverages AI to contextualize requirements, automate document generation, and intelligently manage validation lifecycles. With built-in audit readiness and traceability, the solution enhances compliance integrity while reducing manual effort—allowing CAI clients to focus more on quality and less on paperwork.

“We built Valkit.ai to meet the very real needs of life sciences teams burdened by outdated, resource-heavy validation processes,” said Hugh, Devine, CEO of Valkit.ai. “Partnering with CAI amplifies our ability to deliver meaningful impact at scale—empowering manufacturers to stay compliant, nimble, and future-ready.”

This collaboration directly supports CAI’s strategic focus on digital enablement, which emphasizes the integration of emerging technologies such as large language models, digital twins, and intelligent validation platforms to transform operations and compliance in regulated industries.

Partnership Highlights:

• AI-Augmented Validation: Use of agentic and contextual AI to streamline C&Q, CSV, and CSA
• Accelerated Compliance: Faster validation timelines with improved traceability and reduced manual burden
• Audit Readiness by Design: Proactive, real-time insights to reduce risk and deviation
• Seamless Integration: Scalable, cloud-based solution built for modern pharmaceutical and biotech workflows
• Trusted Expertise: Backed by CAI’s global team of validation and regulatory specialists

Together, CAI and Valkit.ai are delivering the next generation of intelligent validation—bridging the gap between traditional compliance and tomorrow’s digital operations.

About CAI
CAI is a global professional services firm specializing in operational readiness and operational excellence for mission critical and highly regulated industries. With over 30 years of experience and a team of elite engineering, quality, and operations professionals, CAI delivers trusted, tech-enabled solutions that ensure compliance, reduce time-to-market, and optimize performance. Learn more at CAIReady.com.

About Valkit.ai
Valkit.ai is an AI-augmented validation platform built for life sciences. Designed by engineers and regulatory experts, Valkit streamlines GxP validation through intelligent automation and contextual AI. With capabilities that support Commissioning & Qualification, CSV, and CSA, Valkit enables teams to validate faster, with greater accuracy and confidence. Learn more at valkit.ai.

Technical Contact:

Jonathon Thompson, Director of Digital Products, CAI | jonathon.thompson@cagents.com   

Chris Ferrell |Chief Technology Officer, Valkit.ai | chris@valkit.ai