Genari AI’s customers can now benefit from using Agentic AI within Computer Software Assurance to support validation, compliance, design, delivery and change.
San Francisco, May 8, 2025 : Genari AI today announced it has launched GxP Genie on Salesforce AppExchange, a leading enterprise marketplace for partner apps and experts, empowering life sciences organizations to dramatically improve compliance, reduce validation costs, and accelerate innovation.
GxP Genie is currently available on AppExchange here.
GxP Genie is a cloud-native Computer Software Assurance (CSA) platform fully compliant with 21 CFR Part 11 and EU Annex 11 regulations. In support the FDA’s guidance, GxP Genie uses a risk-based approach to validation with multiple AI driven agents working in concert to ensure compliance with ISPE GAMP 5, ISO standards, and other best practices. GxP Genie agents are trained to common standards and can be further trained to meet complex unique requirements.
Legacy CSV processes have been challenging for life sciences companies with manual workflows, excessive documentation, and limited audit readiness and capabilities. Regulators like the FDA increasingly support CSA and digital-first approaches, which means GxP Genie empowers organizations to replace outdated “paper-on-glass” methods with a fully digitized, intelligent platform.
“CSV has reached a breaking point. Manual processes are slowing innovation and inflating risk,” says Rosalind Beasley, CEO of Main and Mission. “GxP Genie’s AI-driven agents provide real-time insights, risk scoring, and automated validation execution to help teams stay compliant, audit-ready, and focused on quality outcomes. This is a no brainer for advancement of CSA.”
Salesforce AppExchange, a leading enterprise marketplace for partner apps and experts, empowers companies, developers and entrepreneurs to build, market and grow in entirely new ways. Since its launch in 2006, the platform has grown to include more than 8,000 apps and experts, with over 13 million customer installs. AppExchange connects customers of all sizes and across industries to ready-to-install or customizable apps and Salesforce-certified consultants to solve any business challenge.
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Genari AI is a digital transformation partner helping life sciences organizations modernize compliance, quality, and validation processes. With solutions like GxP Genie, the company empowers teams to innovate faster while staying aligned with evolving regulatory expectations. For more information, visit genari.ai
