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Feb 11, 2024 •344 likes •1.03k views

Welcome Challenges in Multi-Site Environmental Monitoring Balancing Standardization and Localization for Costs, Risks, and Best Fit Paul Daniel Senior Regulatory Compliance Expert Vaisala, Inc. Vaisala Team Speaker: Paul Daniel Sr.

  1. Welcome Challenges in Multi-Site Environmental Monitoring Balancing Standardization and Localization for Costs, Risks, and Best Fit Paul Daniel Senior Regulatory Compliance Expert Vaisala, Inc.

  2. Vaisala Team Speaker: Paul Daniel Sr. Regulatory Compliance Expert Vaisala, Inc. Chat operator: Janice Bennett-Livingston Marketing Manager, Life Science Vaisala, Inc. Page 2 / 2017 / Challenges in Multi-Site Monitoring

  3. Vaisala in Brief  We serve customers in weather and controlled environment markets  80 years of experience in providing a comprehensive range of innovative observation and measurement products and services Page 3 / 2017 / Challenges in Multi-Site Monitoring

  4. Vaisala - Life Science Our Offering Provides measurement instrumentation, continuous monitoring systems and validation systems for regulated or highly controlled life science environments. Our Goal is to help customers • Reduce their risk of lost or adulterated product • Reduce their risk of failing to meet GxP regulations and/or guidelines Page 4 / 2017 / Challenges in Multi-Site Monitoring

  5. Challenges in Multi-Site Monitoring …When One-Size Doesn’t Fit All

  6. Goals  Enterprise Systems  Why have a single monitoring system for multiple sites?  Multi-Site Challenges  What issues typically arise in a multi-site monitoring system?  Customer Types  Are the issue experienced differently by different customers?  Solutions  How do we solve the multi-site challenges? Page 6 / 2017 / Challenges in Multi-Site Monitoring

  7. What is an Enterprise System?  One application  Many users and sensors instance on centralized server. at peripheral sites via LAN. Page 7 / 2017 / Challenges in Multi-Site Monitoring

  8. Why go Enterprise? Benefits  Risk Mitigation  Cost Savings  Single Point of Vendor Contact NOTE: This may be inevitable… So get ready! Page 8 / 2017 / Challenges in Multi-Site Monitoring

  9. Why not go Enterprise?  One size doesn’t always fit every site….  5 Challenges  Internal Security  Administration  Geographic Spread  Multiple Site Types  IT Infrastructure  The Enterprise benefits are big, and outweigh the problems.  This means - we have to deal with this sooner or later. Page 9 / 2017 / Challenges in Multi-Site Monitoring

  10. Where do the problems come from?  They all come from the move from single-site to multi-site.  Often today’s problem is the result of yesterday’s solution.  Pretending to be “Enterprise”  Root Cause: – Using a single-site system for a multi-site application Page 10 / 2017 / Challenges in Multi-Site Monitoring

  11. Challenge 1: Security  How do I protect my site’s portion of the system?  Prevent changes to my raw data?  Changes to my configuration parameters? – Alarm Threshold Setting – Alarm Notifications – Reports Page 11 / 2017 / Challenges in Multi-Site Monitoring

  12. Challenge 2: Administration  How do I limit administrative burden as we add sites?  Increase efficiency?  Delegate tasks? Page 12 / 2017 / Challenges in Multi-Site Monitoring

  13. Challenge 3: Geography  How do I adapt my system to different time zones?  Time is critical part of monitoring data.  How do I support users in different languages? Page 13 / 2017 / Challenges in Multi-Site Monitoring

  14. Challenge 4: Multiple Site Types  How to ensure that individual site requirements are met?  All required parameters should be included without workarounds. Page 14 / 2017 / Challenges in Multi-Site Monitoring

  15. Challenge 5: IT Infrastructure  Challenge: Find space for new sensors on local network.  Install Ethernet drops and find space on network switches?  Bridge disconnected network segments?  Ensure sufficient bandwidth and signal strength on WiFi? Page 15 / 2017 / Challenges in Multi-Site Monitoring

  16. Poll Slide #1  Do you recognize any of these challenges? Which challenges did you encounter?  Yes, we have experienced the Security Challenge.  Yes, we have experienced the Administration Challenge.  Yes, we have experienced the Geography Challenge.  Yes, we have experienced the Site Variety Challenge.  Yes, we have experienced the IT Infrastructure Challenge.  We experienced “other” challenges. Page 16 / 2017 / Challenges in Multi-Site Monitoring

  17. Different Kinds of Customers  National Warehousers  Regional Hospitals  Global Manufacturers Page 17 / 2017 / Challenges in Multi-Site Monitoring

  18. National Warehousers Page 18 / 2017 / Challenges in Multi-Site Monitoring

  19. National Warehousers  Characteristics  Little Site Variety – All Warehouses  Spread over Region or Nation  Typically open floor plan in buildings Success Stories  McKesson Specialty Health – https://www.vaisala.com/en/case/mckesson-specialty-health-achieves-over-100-audits-without-single-observation  Owens & Minor – http://www.vaisala.fi/Vaisala%20Documents/Success%20Stories/CEN_LSH_Warehouse_Monitoring_Success_Story.pdf  HPS https://www.vaisala.com/en/case/australias-leading-pharmacy-service-provider-safeguards-products-gap-free-data-fail-safe-alarming – Page 19 / 2017 / Challenges in Multi-Site Monitoring

  20. Regional Hospitals Page 20 / 2017 / Challenges in Multi-Site Monitoring

  21. Regional Hospitals  Characteristics  Some Site Variety – Mostly Pharmacy, Some Labs  Spread over Metro Area or Region  Often closed architecture – Multiple older buildings Success Stories  Top Research University – http://www.vaisala.de/Vaisala%20Documents/Success%20Stories/VIM- G%20Pediatric%20Research%20Hospital%20Success%20Story_B211665EN-A_High.pdf  Anaheim Clinical Trials – https://www.vaisala.com/en/case/reliable-environmental-monitoring-system-satisfies-clinical-trial-sponsors-safeguards-life- enhancing-research  Lifesharing http://www.vaisala.fi/Vaisala%20Documents/Success%20Stories/VIM- – G%20LifeSharing%20Tissue%20Storage%20Success%20Story_B211663EN-A_High.pdf Page 21 / 2017 / Challenges in Multi-Site Monitoring

  22. Customer 3: Global Manufacturers Page 22 / 2017 / Challenges in Multi-Site Monitoring

  23. Global Manufacturers  Characteristics  High Site Variety – Warehouses, Labs, Cleanrooms  Spread over globe.  High variety of Infrastructure Wikipedia Top 50 – https://en.wikipedia.org/wiki/List_of_largest_biotechnology_%26_pharmaceutical_companies Latest Success Story  Packaging Coordinators Inc. – https://www.vaisala.com/sites/default/files/documents/CEN-LSC-PCI-selects-Vaisala-Continuous-Monitoring-System-to- ensure-quality.pdf Page 23 / 2017 / Challenges in Multi-Site Monitoring

  24. Customer Summary Chart National Regional Global Warehouser Hospital Manufacturer Security Admin Geo Multi-site IT Page 24 / 2017 / Challenges in Multi-Site Monitoring

  25. Customer Summary Chart National Regional Global Warehouser Hospital Manufacturer Security Admin Geo Multi-site IT Page 25 / 2017 / Challenges in Multi-Site Monitoring

  26. Problem Solving  Typical Solutions  Applied after the fact and create more problems  Recommended Solutions  Applied before-hand and avoid the problem  Must already be built-in by vendor  Vaisala ways to successfully avoid a problem…  Simple and Elegant: One Size Actually Fits All - or -  Configurable: Solution Adapts to Fit All Sizes Page 26 / 2017 / Challenges in Multi-Site Monitoring

  27. The Security Solution  How do I protect my site’s portion of the system?  Prevent changes to my raw data?  Changes to my configuration parameters? – Alarm Threshold Setting – Alarm Notifications – Reports Page 27 / 2017 / Challenges in Multi-Site Monitoring

  28. Single-Site: AMY AMY Page 28 / 2017 / Challenges in Multi-Site Monitoring

  29. Single-Site: AMY shares with ARI AMY ARI Page 29 / 2017 / Challenges in Multi-Site Monitoring

  30. Single-Site: System Grows… AMY ARI Page 30 / 2017 / Challenges in Multi-Site Monitoring

  31. Single Site: ANN helps out ANN AMY ARI Page 31 / 2017 / Challenges in Multi-Site Monitoring

  32. Multi-Site: Sites A and B ANN AMY BRENDA BIANCA ARI Page 32 / 2017 / Challenges in Multi-Site Monitoring

  33. Multi-Site: Sites A and B… and C ANN AMY CHEN BRENDA BIANCA ARI CARRIE Page 33 / 2017 / Challenges in Multi-Site Monitoring

  34. Fix: Procedural “Don’t Look” SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP ANN AMY CHEN BRENDA BIANCA ARI CARRIE Page 34 / 2017 / Challenges in Multi-Site Monitoring

  35. Fix: Super-User SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP ANN AMY CHEN BRENDA BIANCA ARI CARRIE Page 35 / 2017 / Challenges in Multi-Site Monitoring

  36. Fix: Super-User (and Ticket System) SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP ANN AMY CHEN BRENDA BIANCA ARI CARRIE Page 36 / 2017 / Challenges in Multi-Site Monitoring

  37. Solution: Site Segregation ANN BARB AL CHARLES AMY CHEN BRENDA BIANCA ARI CARRIE Page 37 / 2017 / Challenges in Multi-Site Monitoring

  38. One Step Farther… ANN AMY BRENDA CHEN ARI BIANCA CARRIE Page 38 / 2017 / Challenges in Multi-Site Monitoring

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