Skills
About
Nagesh Nama is a seasoned technology executive with over 30 years of experience in the pharmaceutical and biotech industry. As the CEO of xLM since 2015, he leads initiatives to help pharmaceutical, biotech, and medical device companies incorporate AI/ML applications into their GxP processes. He is also the Founder and CEO of ValiMation, established in 1996, which provides IT Quality and Computer Validation Services to life sciences companies. Nama holds an M.S. in Manufacturing Engineering from the University of Massachusetts Amherst. His expertise spans AAI/ML, GxP Data Integrity, Cloud Compliance, and FDA CSA. In recognition of his contributions to the industry, xLM was featured on Bloomberg TV's Advancements series in August 2023. Currently based in Jacksonville, Florida, Nama focuses on helping organizations reduce GxP validation costs while ensuring regulatory compliance in AI/ML implementations. His work bridges the gap between innovative technologies and regulatory requirements in the life sciences sector.
Nagesh Nama
Company details
xLM Continuous Intelligence
Company bio
1️⃣We offer Continuous Intelligent managed services to assist life science clients to migrate to an AI/ML-driven platform with built-in intelligent validation. 2️⃣WHO IS THIS FOR? Our clientele includes multinational pharmaceutical corporations, agile biotech firms, and medical device companies. 3️⃣ HOW DO WE HELP? We can assist you in migrating to an intelligent platform with many pre-built AI/ML apps. We deliver all our apps with best practices and intelligent validation baked in. We will help you reduce costs, increase workflow efficiency, comply better…..all these by a factor 10x or more. 4️⃣ WHAT DO WE DO? We have pioneered a "continuous intelligence" platform that enhances compliance, mitigates risks, and streamlines your GxP processes. These processes span predictive analytics for operations and maintenance, temperature mapping for storage areas, real-time compliance monitoring for 21 CFR Part 11, intelligent validation for computer systems and more. Our managed services exceed the current expectations set by the FDA's CSA. Our AI/ML models are monitored for compliance by IBM’s watsonx.gov.