Insigniam’s Post

The Fall 2024 Issue of IQ Insigniam Quarterly® will go live in two weeks! The upcoming issue will explore several key sectors—including energy, insurance, financial services, healthcare, medtech, biopharma, CPG, and cybersecurity—to better understand critical risks and success factors facing executives and enterprises. Subscribe here to receive the new fully digital issue, coming soon: https://okt.to/5aX7xg

For life sciences, the race to bring innovative therapies and wellness-enhancing products to market is more competitive and urgent than ever. Our new whitepaper explores how intelligent automation within regulatory information management offers a transformative solution. Download our whitepaper to learn more: 👉 https://bit.ly/4dHGfXg 👈 #WeAreCGI #LifeSciences #CGIUS

In a panel discussion moderated by Metis Strategy Partner and West Coast Lead Chris Davis, Shobie Ramakrishnan, CDTO of GSK, and Diego S., CIO of Gates Corporation, discuss building #resilience through technology amid disruption. Shobie, hailing from a long-standing #science and #pharmaceutical company, emphasizes the importance of innovation and the dual approach of playing offense and defense in digital and technological implementations to impact global health positively. Diego shares insights from Gates Corporation’s #manufacturing and materials science advancements, highlighting how investing during downturns can prepare a company for future success. Both executives explore the significance of #cybersecurity, #AI responsibility, and #supplychainmanagement in maintaining a resilient organization and underscore the need to balance investment in innovation with risk management to navigate uncertain times effectively. David Setti :: Shilpa Yelamaneni :: Amanda Briden https://lnkd.in/gByUwNj3

In fast-paced, regulated environments like pharma, biotech, and healthcare, 𝗿𝗲𝗮𝗹-𝘁𝗶𝗺𝗲 𝗱𝗮𝘁𝗮 offers more than just quick info—it’s the difference between smooth operations and unexpected disasters. ⚡ With real-time monitoring, you’re not just responding to problems; you’re anticipating them. From detecting temperature spikes to predicting when equipment needs maintenance, real-time data keeps your facility safe, compliant, and running smoothly. 🚨 🔑 𝗪𝗵𝘆 𝗜𝘁 𝗠𝗮𝘁𝘁𝗲𝗿𝘀: • Instant detection and response ⏱️ • Reduces downtime ⏳ • Helps you stay proactive, not reactive 💡 #RealTimeData #EnvironmentalMonitoring #PredictiveAnalytics #Compliance #QualityControl

Unlock the secrets to thriving in the digital landscape with our exclusive webinar. Teaming up with industry analyst firm, IDC, we delve into the transformative potential of a strategic, enterprise-wide approach for pharmaceutical enterprises. Discover how bolstering data integrity and quality can revolutionize batch manufacturing and ensure regulatory compliance. Dive into the world of #EdgeComputing, where seamless integration of IT and operational systems provides a comprehensive 360 Edge-to-Enterprise perspective with real-time data insights. Don't let this opportunity slip away—secure your spot now and embark on the journey to operational excellence.

Discover how #Pharma can overcome challenges and seize opportunities in the digital age. Join our webinar with industry analyst firm, IDC , and learn about the power of a strategic, enterprise-wide approach to enhance data integrity and quality to improve batch #manufacturing and achieve regulatory compliance. Explore how #EdgeComputing can integrate IT and operational systems, enabling a unified 360 Edge-to-Enterprise view with real-time data. Don't miss out on transforming your operations for success. Sign up now. https://loom.ly/uK9k0-I

📈The regulatory landscape is changing significantly! Is your organization keeping up and proactively planning for these shifts? I had a chance to talk with Naveen Agarwal, Ph.D. on a recent "Let’s Talk Risk!" session where we explored some of the significant changes that are impacting the MedTech industry today. In this Let’s Talk Risk! conversation, we focused on three big trends happening in MedTech right now: ✅ The shift from Quality System Regulation (QSR) to Quality Management System Regulation (QMSR) ✅ Regulatory focus on cybersecurity in medical devices ✅ Shifting FDA regulations regarding Laboratory Developed Tests (LDT). 👇Listen to the full session below Did you find this post interesting? ♻️ Reshare with your network ➡️ Follow JMT Compliance Consulting and Naveen Agarwal, Ph.D. 📧 Subscribe to Naveen's "Let's Talk Risk" Page where he is constantly publishing amazing content (see comments).

The #USHouse of Representatives has passed the #BiosecureAct with overwhelming bipartisan support. If enacted, this bill has significant implications for #biotechmanufacturing, the #supply chain, and ultimately #drugprices. The #legislation restricts US companies from collaborating with Chinese biotech firms like WuXi AppTec and WuXi Biologics, citing national security risks. While aimed at protecting national security and sensitive healthcare data, the bill could disrupt #drugsupplychains. The Act shines a light on vulnerabilities in the US supply chain, emphasizing the need for stronger domestic capabilities in manufacturing and workforce development. The bill now moves to the Senate, where similar support is expected, industry leaders will be watching the results closely.

As House Rx expands its footprint in the intersection of technology and pharmaceuticals, ensuring robust data security is critical.🔒 With over 10 million records and terabytes of personally identifiable information (PII) and protected health information (PHI) across 350+ data stores and 3500+ data tables, the challenge was real. See how we helped House RX seamlessly safeguard sensitive data and meet compliance and auditing requirements: https://hubs.ly/Q02KBm4G0 #datasecurity #compliance #data #DSPM #BedrockSecurity

Harness streaming data from diverse sources to fuel real-time analytics, enabling a spectrum of applications spanning from overseeing hospital bed availability to refining the production and distribution processes in the pharmaceutical industry. Learn more here: https://lnkd.in/ggiT5tGK #healthandlifesciences #hls #dataanalytics