fme US, LLC’s Post

Maximize the ROI and capability of your RIM environment with fme’s HealthCheckAssist – our newest solution built from the ground up to analyze, evaluate, and optimize your RIM environment. With detailed stakeholder interviews and in-depth technical analysis, we show your where you are and a map for where you need to be in the future. #regulatory #RIM

Don’t wait. End the year with the details you need to get the most from your RIM solution. With interviews by regulatory experts and detailed insights from fme’s custom-built dqMan toolset, our HealthCheckAssist clears the fog from your view to reveal a clear path to an efficient, effective and compliant environment. Learn more below. #regulatory #RIM

Regulatory information management is often a convoluted and quickly evolving space, with substantial costs for any mistakes. Don’t underestimate the risks. fme is a proven RIM solution provider and understands the complexities of your RIM environment. Take advantage of HealthCheckAssist and understand how to eliminate risks and amplify the capabilities of your system for 2025. Learn more below and be ready for the new year. #regulatory #RIM

Get a detailed assessment of your RIM solution to start 2025 of strong. fme’s HealthCheckAssist leverages qualitative and quantitative data to show you where you are, and where you should go to keep your system effective, efficient, and fully compliant with evolving requirements. Contact us to get started. #regulatory #RIM

Don’t take risks with your RIM. Is your RIM solution updated and optimized for the newest requirements and your business processes? Don’t guess. fme’s HealthCheckAssist is built to uncover risks and ensure you are leveraging the full power of your RIM solution. Learn more now, and get started before 2025 begins. #regulatory #RIM

Don’t be a turkey 🦃, worried that your RIM solution isn’t ready to handle the challenges coming in the new year. Take advantage of fme’s HealthCheckAssist and develop a complete streamlining and optimization pathway that aligns with your organizational objectives. With years of proven regulatory experience, fme’s experts will get you where you need to be in no time. Learn more below. #regulatory #RIM

Now is the time to optimize your RIM solution before 2025 arrives. fme’s HealthCheckAssist is a comprehensive solution to uncover your RIM platform's hidden risks and unused capabilities. Let's connect to discuss how we can help you get a clear picture of where you are so you can effectively plan for 2025. Learn more below! #regulatory #RIM

Hello Friends and Colleagues, I am very excited to announce a new service from fme! HealthCheckAssist℠ 🚀 Navigating the complexities of regulatory compliance is a formidable challenge for organizations in the life sciences sector. With HealthCheckAssist℠, we're offering a cutting-edge solution that optimizes your RIM system, ensuring your organization stays ahead of the curve. Dive into our latest post to discover how HealthCheckAssist℠ can streamline your processes, enhance data quality, and safeguard your compliance strategy. Click to learn more! #RegulatoryCompliance #LifeSciences

📊 Delivering the data that matters. 📊 Our 𝗣𝗶𝗽𝗲𝗹𝗶𝗻𝗲 𝗦𝘂𝗿𝘃𝗲𝘆𝗼𝗿𝘀 go beyond inspection by providing both real-time online and onsite data. After the inspection, we offer detailed analysis and a full report within weeks, giving you the insights needed for informed decisions on your pipeline’s health. We also offer additional support through our PRIMS data management platform and integrity assessments, ensuring you have a complete understanding of your pipeline’s condition—from defect analysis to fitness-for-service evaluations. Make better decisions with data that counts. #InteroIntegrity #PipelineData #RealTimeReporting #PRIMS #PipelineInspection #IntegrityAssessment #InformedDecisions

How to use a risk-based approach for CAPA? (What we can learn from 'Make CAPA cool') I just finished reading the whitepaper. The idea: Risk-based thinking will transform the process into a more effective and user-friendly tool. The main thought is to put 2 systems in place: → Fast Track CAPA → External CAPA Fast Track CAPA is: 1. within an organization's control 2. managed through existing QMS processes 3. designed for internal events and low-risk trend Using this path enables organizations to: • make more numbers of improvements over time • less detailed investigations (if cause is obvious) • rely on total QMS data to prove effectiveness External CAPA is: 1. done in the 'old documentation heavy' way 2. linked to potential patient or user safety impact 3. intended for external events and high-risk trends This is our traditional CAPA: • crossfunctional team for insights • deep and thorough root cause investigation • robust and time-bound effectiveness checks To sum it up: Old way ↳ Document everything. Drown in paperwork. New way ↳ Focus on high-risk issues. Solve real problems. What's your take on this? Did you read the paper? PS - You'll find more insights in the comments. ↓ ________________________________________________ My name is Georg, and I talk about MedTech CAPA. ♻️ Repost to spread the message. Thank you!