fme US, LLC

#VeevaSummit is heading to Madrid for two days next month, and the fme team will be there again sharing our latest Veeva project successes and solutions! Join us to be part of the Veeva Community of life sciences professionals June 4-5 to: 🎤 Hear from industry experts and companies driving real change. 💡 See the latest product innovations from Veeva. 🤝 Connect with old friends and make new ones. Learn more at the link below, and contact us if you are attending, we'd love to see you there! https://lnkd.in/evfJH5E

Make sure your regulatory colleagues are recognized for their great work - the 2025 TOPRA Award nominations are open! Nominate your inspirational teams in any of the 8 different categories. fme recognizes that the rapid pace of technological change requires innovation and commitment to stay efficient, flexible, and cost effective. We are honored to sponsor the Innovation category again this year to recognize and spotlight the new ideas necessary to lead us into the future. Who will you nominate? #TOPRA #RegAwards25

🔎 Are you stuck in the OpenText status quo? OpenText offers stability, but staying ahead means evolving with your business needs. ✅ Simplify integrations with modern best-of-breed solutions ✅ Reduce storage & maintenance costs ✅ Optimize workflows for maximum efficiency At fme, we specialize in making your OpenText solutions work smarter—without costly rework. 📖 Find out how to maximize your OpenText investment. #LifeSciences #OpenText #Optimization https://lnkd.in/grDDaWm4

📣 NEW TEAM MEMBER 📣  fme is always growing, and we are excited to announce Donald Mackenzie is joining the team! Don is a seasoned project management professional with over two decades of experience delivering complex, high-value projects within the life sciences sector. A certified PRINCE2 Practitioner and PMI-trained manager, he excels at leading global teams through full project lifecycles using Agile, Waterfall, and hybrid methodologies. His approach is pragmatic, data-driven, and focused on delivering sustainable results through strong stakeholder engagement and continuous improvement.   Don brings deep expertise in legacy document management systems, having managed global FirstDoc environments and overseen the migration to modern platforms like Veeva Vault. He has hands-on experience with Veeva eTMF, QualityDocs, PromoMats, and QMS modules, and holds Veeva Vault Administrator certifications.   Notably, Don has successfully led programs for some of the world’s largest pharmaceutical and biotech organizations including AstraZeneca, Daiichi-Sankyo, Novartis, and Jazz Pharmaceuticals. His work has spanned regulatory, clinical, quality, and pharmacovigilance domains, with a consistent focus on compliance (GxP, GAMP, ISO9001), digital transformation, and operational efficiency. Outside of his fme work, Don disconnects from the technical world to a rural homestead with two horses and thirty sheep! #LifeSciences #NewHire

Preparing for an inspection? Struggling with user complaints? 🚩  The issue might not be your team—it might be your system configuration. Veeva RIM platforms change fast. If you haven’t assessed your environment recently, you could be exposing your org to risk without realizing it. fme’s HealthCheckAssist delivers a roadmap to get back on track—before audit day arrives. ✅ Learn what warning signs to watch for:  https://lnkd.in/dMjHARYj #LifeSciences #Veeva #regulatory #RIM

Generis CARA offers flexibility, intelligence, and integration for life sciences quality systems. But to unlock its full value, your migration strategy must be just as forward-thinking. fme is a trusted, Generis-certified partner for CARA migrations at global scale. With migration-center®, deep domain knowledge, and a track record of success, we help organizations move to CARA securely, efficiently, and with zero compromise on compliance. Learn more about how we lead the way in CARA migrations. #migration #Generis #QMS #Quality #LifeSciences https://lnkd.in/gnymM8kU

📣 NEW TEAM MEMBER 📣  We are excited to announce the newest member of our team James Calabria, joining fme as a Principal Consultant. Jim has 25 years of life sciences experience working with the largest clients in the industry. His skill at delivering on global data migration projects in Regulatory, Clinical and Quality systems and data is a powerful addition to the fme team. With focus, dedication and attention to detail, Jim’s unique experience with Life Sciences clients will add detailed knowledge and perspective to fme’s projects and enhance fme’s value with our clients and partners. Outside of work, Jim spends his time with his family, enjoying nature and working on construction projects and solar energy systems. We look forward to the impact Jim is certain to bring with his experience and ‘can-do’ approach. Welcome to the fme team, Jim!   #LifeSciences #NewHire

A move to a new QMS platform like Generis CARA comes with high expectations—and high stakes. It's not just about migrating records. It's about preserving compliance, enabling usability, and ensuring continuity across quality-critical processes. fme has the tools and experience to make your CARA migration a success. We’re working with some of the largest global life sciences organizations to execute complex transitions with speed, traceability, and precision. Explore how we deliver transformation with confidence. #migration #Generis #QMS #Quality #LifeSciences https://lnkd.in/gnymM8kU

Navigating software selection for regulatory operations requires precision and clarity. Find out how fme’s SelectAssist methodology empowered a leading pharmaceutical company to make a confident, data-backed choice aligned with long-term business and regulatory objectives. #LifeSciences #RegulatoryAffairs #SoftwareSelection #DigitalTransformation #SelectAssist #RIM #Publishing https://lnkd.in/gdHx4SZf

🏢 Your OpenText environment has been reliable for years—but is it holding you back? Many enterprises stick with their legacy OpenText systems because they work. But here’s the problem: ⚡ Legacy user experiences slow down productivity ⚡ Data storage costs exceed the value of old data ⚡ AI capabilities are out of reach due to outdated data structures Modernizing doesn’t mean starting over. Our team at fme helps businesses optimize, migrate, and integrate without unnecessary disruptions. 📌 Maximize your OpenText investment—read our latest insights. #LifeSciences #OpenText #Optimization https://lnkd.in/grDDaWm4