p36 GmbH

🚀 𝐖𝐞𝐥𝐜𝐨𝐦𝐞 𝐭𝐨 𝐭𝐡𝐞 𝐭𝐞𝐚𝐦, 𝐑𝐨𝐛𝐢𝐧𝐬𝐨𝐧! 🎉 We’re happy to welcome Robinson Odhiambo to p36 GmbH as a 𝐅𝐮𝐥𝐥 𝐒𝐭𝐚𝐜𝐤 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐞𝐫! Great to have you with us as we continue building smart, compliant solutions for the life sciences industry. Let’s create something great together! 💡✨ #WelcomeToTheTeam #FullStackDeveloper #Innovation #LifeSciences #p36

🚨 𝐄𝐒𝐆 𝐍𝐞𝐱𝐭𝐆𝐞𝐧 𝐆𝐨-𝐋𝐢𝐯𝐞 – 𝐖𝐞 𝐌𝐚𝐝𝐞 𝐈𝐭! 🚀 The FDA flipped the switch – and we were ready. ✅ Thanks to incredible teamwork, our systems – and our customers – stayed fully operational as the 𝐅𝐃𝐀’𝐬 𝐄𝐒𝐆 𝐍𝐞𝐱𝐭𝐆𝐞𝐧 𝐬𝐲𝐬𝐭𝐞𝐦 went live. Despite tight timelines and last-minute, undocumented changes from the FDA, our UDI team moved fast to adapt and support customers through testing before the freeze. 💥 Without that quick response, GUDID submissions would have failed – risking serious compliance issues. 👏 Huge kudos to 🎯 Pascal Appel – for analyzing and leading the change, 📢 Przemysław Kowalski – for keeping customer communication calm and clear, 🔧 Mark Wiesenthal & Jonas Hasenauer – for swiftly updating our FDA adapter to keep everything running smoothly. This is what agility, expertise, and teamwork look like. Outstanding work, team! Are you interested how the p36 UDI Platform works? Request your personal demo here: https://lnkd.in/eDNCQpHr

𝐖𝐡𝐲 𝐭𝐫𝐮𝐬𝐭 𝐚 𝐂𝐒𝐐 𝐩𝐥𝐚𝐭𝐟𝐨𝐫𝐦? 𝐁𝐞𝐜𝐚𝐮𝐬𝐞 𝐒𝐀𝐏 𝐁𝐓𝐏 𝐢𝐧 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐞𝐝 𝐞𝐧𝐯𝐢𝐫𝐨𝐧𝐦𝐞𝐧𝐭𝐬 𝐧𝐞𝐞𝐝𝐬 𝐦𝐨𝐫𝐞 𝐭𝐡𝐚𝐧 𝐭𝐞𝐜𝐡𝐧𝐢𝐜𝐚𝐥 𝐞𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 – 𝐢𝐭 𝐧𝐞𝐞𝐝𝐬 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐛𝐲 𝐝𝐞𝐬𝐢𝐠𝐧. For MedTech, and Life Sciences companies, SAP Business Technology Platform (SAP BTP) unlocks massive innovation potential. But operating in a GxP-regulated space means you also need full control over qualification and documentation. That’s where our CSQ Platform comes in – enabling a 𝐫𝐢𝐬𝐤-𝐛𝐚𝐬𝐞𝐝 𝐚𝐩𝐩𝐫𝐨𝐚𝐜𝐡 𝐭𝐨 𝐪𝐮𝐚𝐥𝐢𝐟𝐲𝐢𝐧𝐠 𝐚 𝐩𝐮𝐛𝐥𝐢𝐜 𝐜𝐥𝐨𝐮𝐝 𝐩𝐥𝐚𝐭𝐟𝐨𝐫𝐦 and aligning your operations with GxP expectations from day one. Here are 𝟓 𝐤𝐞𝐲 𝐚𝐝𝐯𝐚𝐧𝐭𝐚𝐠𝐞𝐬 of using our 𝐂𝐥𝐨𝐮𝐝 𝐒𝐞𝐫𝐯𝐢𝐜𝐞 𝐐𝐮𝐚𝐥𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 (𝐂𝐒𝐐) 𝐏𝐥𝐚𝐭𝐟𝐨𝐫𝐦 for SAP BTP: ✅ 𝐀𝐜𝐜𝐞𝐥𝐞𝐫𝐚𝐭𝐞𝐝 𝐪𝐮𝐚𝐥𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 – Audit-ready documentation for SAP BTP services ✅ 𝐋𝐢𝐟𝐞𝐜𝐲𝐜𝐥𝐞 𝐭𝐫𝐚𝐧𝐬𝐩𝐚𝐫𝐞𝐧𝐜𝐲 – Full traceability of service changes and updates ✅ 𝐎𝐩𝐭𝐢𝐦𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐚𝐮𝐝𝐢𝐭 𝐩𝐫𝐨𝐜𝐞𝐬𝐬𝐞𝐬 – With a significant increase in efficiency ✅ 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐚𝐥𝐢𝐠𝐧𝐦𝐞𝐧𝐭 – Based on current GAMP® and GxP guidance ✅ 𝐁𝐨𝐨𝐬𝐭𝐞𝐝 𝐢𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 – Strengthen your innovation power and shorten time-to-market Using SAP BTP in a GxP context? 👉 𝐒𝐞𝐞 𝐡𝐨𝐰 𝐨𝐮𝐫 𝐂𝐒𝐐 𝐏𝐥𝐚𝐭𝐟𝐨𝐫𝐦 𝐬𝐮𝐩𝐩𝐨𝐫𝐭𝐬 𝐲𝐨𝐮𝐫 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐣𝐨𝐮𝐫𝐧𝐞𝐲 – 𝐛𝐨𝐨𝐤 𝐲𝐨𝐮𝐫 𝐩𝐞𝐫𝐬𝐨𝐧𝐚𝐥 𝐝𝐞𝐦𝐨 𝐭𝐨𝐝𝐚𝐲: https://lnkd.in/epJRBwvi #CSQ #SAPBTP #LifeSciences #GxP #Pharma #MedTech #CloudCompliance #AuditReady #DigitalValidation #p36 #SAP #Qualification #CSV #Innovation

𝐖𝐡𝐲 𝐭𝐫𝐮𝐬𝐭 𝐚 𝐔𝐃𝐈 𝐩𝐥𝐚𝐭𝐟𝐨𝐫𝐦? 𝐁𝐞𝐜𝐚𝐮𝐬𝐞 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐬𝐡𝐨𝐮𝐥𝐝𝐧'𝐭 𝐬𝐥𝐨𝐰 𝐲𝐨𝐮 𝐝𝐨𝐰𝐧. For companies in MedTech and Life Sciences, navigating global UDI requirements can be complex and time-consuming. But with the right platform, it doesn't have to be. Here are the 𝟓 𝐤𝐞𝐲 𝐚𝐝𝐯𝐚𝐧𝐭𝐚𝐠𝐞𝐬 of using a dedicated UDI platform: ✅ 𝐆𝐥𝐨𝐛𝐚𝐥 𝐫𝐞𝐚𝐝𝐢𝐧𝐞𝐬𝐬 – Stay aligned with evolving UDI regulations across all major markets ✅ 𝐅𝐚𝐬𝐭𝐞𝐫 𝐬𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬 – Streamlined data entry and validation save valuable time ✅ 𝐃𝐚𝐭𝐚 𝐜𝐨𝐧𝐬𝐢𝐬𝐭𝐞𝐧𝐜𝐲 – Ensure accuracy across all systems and health authorities ✅ 𝐀𝐮𝐝𝐢𝐭 𝐜𝐨𝐧𝐟𝐢𝐝𝐞𝐧𝐜𝐞 – Be prepared for inspections with traceable, compliant data ✅ 𝐒𝐜𝐚𝐥𝐚𝐛𝐢𝐥𝐢𝐭𝐲 – One solution that grows with your product portfolio and markets Curious how it works in practice? 👉 𝐒𝐞𝐞 𝐨𝐮𝐫 𝐔𝐃𝐈 𝐏𝐥𝐚𝐭𝐟𝐨𝐫𝐦 𝐢𝐧 𝐚𝐜𝐭𝐢𝐨𝐧 – 𝐛𝐨𝐨𝐤 𝐲𝐨𝐮𝐫 𝐩𝐞𝐫𝐬𝐨𝐧𝐚𝐥 𝐝𝐞𝐦𝐨 𝐰𝐢𝐭𝐡 𝐮𝐬 𝐭𝐨𝐝𝐚𝐲: https://lnkd.in/eDNCQpHr #UDI #LifeSciences #MedTech #Pharma #RegulatoryCompliance #DigitalHealth #GxP #p36 #SAPBTP #EUDAMED #FDA #UDIPlatform #Innovation

𝐂𝐚𝐥𝐥, 𝐑𝐚𝐢𝐬𝐞 𝐨𝐫 𝐅𝐨𝐥𝐝? 🎲 Unsere Kollegen Daniel Kawkab, Noah David Beckering, Sebastian Koch, Ikenna Okeke, Jan Wehmeyer und Pascal Crenzin waren für p36 GmbH auf den #DSAGTechnologietagen 2025 unterwegs und haben spannende Eindrücke mitgebracht – von SAP BTP über Enterprise Architecture bis hin zur Bedeutung starker Partnerschaften in der Cloud-Transformation. Ihr Fazit: Struktur schlägt Zufall. 👉 𝐉𝐞𝐭𝐳𝐭 𝐫𝐞𝐢𝐧𝐬𝐜𝐡𝐚𝐮𝐞𝐧 𝐮𝐧𝐝 𝐦𝐢𝐭𝐝𝐢𝐬𝐤𝐮𝐭𝐢𝐞𝐫𝐞𝐧! #SAPBTP #DSAGTT #CloudTransformation #EnterpriseArchitecture #SAPCommunity #p36

Thank you to everyone who joined our 𝐂𝐮𝐬𝐭𝐨𝐦𝐞𝐫 𝐖𝐞𝐛𝐢𝐧𝐚𝐫 𝐨𝐧 𝐭𝐡𝐞 𝐂𝐨𝐧𝐭𝐞𝐧𝐭 𝐏𝐚𝐜𝐤𝐚𝐠𝐞 𝐑𝐨𝐚𝐝𝐦𝐚𝐩 this week – it was great to have you with us! A special thanks to Przemysław Kowalski and Pascal Appel for their valuable contributions and insights during the session. Your input helps shape our roadmap and ensures we're delivering exactly what our customers need. Looking forward to the next steps - and to continuing the conversation with all of you! #p36 #UDI #CustomerWebinar #ContentPackage #MedicalDevices #LifeSciences #ThankYou

𝐄𝐱𝐭𝐞𝐧𝐝𝐞𝐝 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐁𝐫𝐞𝐚𝐤-𝐨𝐮𝐭 𝐚𝐭 𝐩𝟑𝟔 🚀 Last week, our management team came together for another inspiring Management Break-out – a frequent practice that gives us the space to step back, reflect, and look ahead. This time, our focus was on the Product Roadmap and the strategic implications for our entire organization. The discussions were intense, forward-thinking, and energizing – exactly the kind of exchange that fuels our passion for building the future of compliance in the cloud. We’re excited about what’s ahead and more motivated than ever to turn our vision into reality. 𝐎𝐧𝐰𝐚𝐫𝐝 𝐚𝐧𝐝 𝐮𝐩𝐰𝐚𝐫𝐝! 💡🌍 #Teamp36 #Leadership #Strategy #Innovation #ProductRoadmap #LifeSciences #CloudCompliance

We’re proud to see our CEO Patrick Pfau’s recent thought leadership piece highlighted as a “𝑚𝑢𝑠𝑡-𝑟𝑒𝑎𝑑” in the 𝐃𝐢𝐠𝐢𝐭𝐚𝐥 𝐓𝐫𝐚𝐧𝐬𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 & 𝐓𝐞𝐜𝐡 𝐍𝐞𝐰𝐬𝐥𝐞𝐭𝐭𝐞𝐫: 𝐂𝐥𝐨𝐮𝐝 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐂𝐖𝟏𝟏/𝟏𝟐 by Thomas Allgeyer. In his article, Patrick explores a key question for the regulated industry: 👉 Why are Life Sciences companies still hesitant to adopt public cloud solutions? A topic that clearly resonates – not just with us at p36 GmbH, but across the cloud and compliance community. 📖 Read Patrick’s full article here: https://lnkd.in/ehrx8Tx2   📩 See the Cloud Insights feature here: https://lnkd.in/e-m7bseg #LifeSciences #PublicCloud #GxP #SAPBTP #Compliance #ThoughtLeadership #p36 #CloudInsights #SaaS #DigitalTransformation

🔧 𝐔𝐩𝐜𝐨𝐦𝐢𝐧𝐠 𝐂𝐡𝐚𝐧𝐠𝐞𝐬 𝐭𝐨 𝐅𝐃𝐀 𝐆𝐔𝐃𝐈𝐃 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧: 𝐖𝐡𝐚𝐭 𝐘𝐨𝐮 𝐍𝐞𝐞𝐝 𝐭𝐨 𝐊𝐧𝐨𝐰 The FDA is upgrading its Electronic Submissions Gateway (ESG) as part of the 𝐍𝐞𝐱𝐭𝐆𝐞𝐧 𝐦𝐢𝐠𝐫𝐚𝐭𝐢𝐨𝐧, impacting all GUDID data submissions—including those made through the p36 UDI Platform. 💡 𝐖𝐡𝐚𝐭’𝐬 𝐡𝐚𝐩𝐩𝐞𝐧𝐢𝐧𝐠? Between 𝐌𝐚𝐫𝐜𝐡 𝐚𝐧𝐝 𝐀𝐩𝐫𝐢𝐥 𝟐𝟎𝟐𝟓, the legacy ESG system will be migrated to ESG NextGen. During this time, there will be several planned submission freeze periods. While the submission method via 𝐀𝐒𝟐 remains unchanged for now, it's critical to ensure your systems and access rights are fully aligned with the new ESG infrastructure. At p36 GmbH, we're proactively supporting our customers through this transition and will keep you updated at every step. 📩 If you have questions or need help with your setup, our 𝐔𝐃𝐈 𝐒𝐮𝐛𝐣𝐞𝐜𝐭 𝐌𝐚𝐭𝐭𝐞𝐫 𝐄𝐱𝐩𝐞𝐫𝐭 Przemysław Kowalski is here for you. #UDI #FDA #GUDID #ESGNextGen #MedicalDevices #Compliance #SaaS #p36 #DigitalHealth #LifeSciences #RegulatoryAffairs

Ob Calls, Workshops oder Reisen – der Kalender ist oft voll. Umso wichtiger ist es, bewusst Momente für sich zu schaffen. 🌿 Wir schätzen es sehr, wenn Kolleg:innen wie Florian Kekule ihren eigenen Weg finden, im oft dichten Arbeitsalltag Kraft zu tanken – und das auch offen teilen. Danke für diesen persönlichen Einblick! 🙌 #p36 #WorkLifeBalance #SelfCare #MentalHealth #p36Spirit