Welcome. Challenges in Multi-Site Environmental Monitoring. Balancing Standardization and Localization for Costs, Risks, and Best Fit

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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 instance on centralized server. Many users and sensors 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 Owens & Minor HPS 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 G%20Pediatric%20Research%20Hospital%20Success%20Story_B211665EN-A_High.pdf Anaheim Clinical Trials Lifesharing 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 Latest Success Story Packaging Coordinators Inc. Page 23 / 2017 / Challenges in Multi-Site Monitoring

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

25 Customer Summary Chart National Warehouser Regional Hospital Global 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 BRENDA AMY BIANCA ARI Page 32 / 2017 / Challenges in Multi-Site Monitoring

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

34 Fix: Procedural Don t Look BRENDA BIANCA SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP ANN AMY ARI SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP CHEN CARRIE Page 34 / 2017 / Challenges in Multi-Site Monitoring

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

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

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

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

39 Security Solution Summary Typical Solution with Procedural Controls Don t look privacy policy. Use standard Security to centralize administrative tasks Super-users and ticket system. Recommended Solution Create true segregation of sites with logical security. Built-in Solution Cannot be applied as a fix. viewlinc Solution goes one step farther Define which areas and sensors can be affected by each user group. Object level security Page 39 / 2017 / Challenges in Multi-Site Monitoring

40 Object Level Security: ANN s View ANN BRENDA AMY CHEN BIANCA ARI CARRIE Page 40 / 2017 / Challenges in Multi-Site Monitoring

41 Object Level Security: AMY s View ANN AMY ARI Page 41 / 2017 / Challenges in Multi-Site Monitoring

42 Security Solution Summary Typical Solution with Procedural Controls Don t look privacy policy. Use standard Security to centralize administrative tasks Super-users and ticket system. Recommended Solution Create true segregation of sites with logical security. Built-in Solution Cannot be applied as a fix. viewlinc Solution goes one step farther Define which areas and sensors can be affected by each user group. Object level security Page 42 / 2017 / Challenges in Multi-Site Monitoring

43 The Administration Solution Page 43 / 2017 / Challenges in Multi-Site Monitoring

44 Administration Headache Part 1 10 complex alarms 40 Components 20 Thresholds 20 Notifications Page 44 / 2017 / Challenges in Multi-Site Monitoring

45 Administration Headache Part 2 20 complex alarms 80 Components 40 Thresholds 40 Notifications Page 45 / 2017 / Challenges in Multi-Site Monitoring

46 Administration Headache Part 2 20 complex alarms 80 Components 40 Thresholds 40 Notifications Page 46 / 2017 / Challenges in Multi-Site Monitoring

47 Solution 2: Administration Typical Solution Procedural Controls Centralize admin tasks with super-users. Create ticket system Standardize configurations for all sites Decrease options to decrease workload Page 47 / 2017 / Challenges in Multi-Site Monitoring

48 Alarm Configuration Analysis 20 complex alarms 80 Components 40 Thresholds 40 Notifications Use 7 Templates Only 4 Thresholds Page 48 / 2017 / Challenges in Multi-Site Monitoring

49 Alarm Configuration Analysis 20 complex alarms 80 Components 40 Thresholds 40 Notifications Use 7 Templates Only 4 Thresholds Only 3 Notifications Page 49 / 2017 / Challenges in Multi-Site Monitoring

50 Solution 2: Administration Typical Solution Procedural Controls Centralize admin tasks with super-users Create ticket system Standardize configurations for all sites Decrease options to decrease workload Recommended Solution (Vaisala Approach) Identify Best Practices in Monitoring Optimize for Administration based on templates Thresholds, Notifications, Users, Schedules Page 50 / 2017 / Challenges in Multi-Site Monitoring

51 The Geography Solution How do I adapt my system to different time zones? Time is a critical part of monitoring data. How do I support users in different languages? Page 51 / 2017 / Challenges in Multi-Site Monitoring

52 Geography Challenge Example London Paris Berlin Helsinki UTC +0 Corporate Headquarters UTC +1 Research Facility UTC +1 Warehouse UTC +2 Cleanroom Typical Procedural Fix System runs in Corporate Time and Language Report all data in Corporate Time Zone System use in Corporate Language Risks Language Errors Time Conversion Errors Lack of Local System Ownership Page 52 / 2017 / Challenges in Multi-Site Monitoring

53 Geography Challenge Example London Paris Berlin Helsinki UTC +0 Corporate Headquarters UTC +1 Research Facility UTC +1 Warehouse UTC +2 Cleanroom Vaisala Technology Solution System is time and language intuitive. Reports labeled with configurable time zone. Users see system in local time and language. 8 Languages available: English Portuguese Spanish Swedish French Japanese German Chinese Page 53 / 2017 / Challenges in Multi-Site Monitoring

54 Multiple Site Types Solution How do we ensure that individual site requirements are met? All required parameters must be included without workarounds. Page 54 / 2017 / Challenges in Multi-Site Monitoring

55 The Multiple Site Types Solution Typical Solution Pick a system with basic parameters. Import unusual parameters with work-arounds. Custom code to import data. More potential points of failure. Increased validation effort. Page 55 / 2017 / Challenges in Multi-Site Monitoring

56 Multiple Sites need Multiple Parameters Typical System Sensors Temperature (-40 C to +40 C) Relative Humidity Door Contacts Import all other parameters Custom programming Vaisala viewlinc Data Loggers Temperature (-196 C to +80 C) Relative Humidity Door Contacts Differential Pressure CO 2 Vaporized Hydrogen Peroxide Dewpoint Barometric Pressure Universal Input Loggers Standardized Import Page 56 / 2017 / Challenges in Multi-Site Monitoring

57 The Multiple Site Types Solution Typical Solution Pick a system with usual parameters. Import unusual parameters with work-arounds. Custom code to import data. Vaisala Solution More potential points of failure. Increased validation effort Offer more parameters than other systems. We manufacture the sensors. Input specialized measurements via universal loggers. Standardized input pathways reduces complexity. Page 57 / 2017 / Challenges in Multi-Site Monitoring

58 IT Infrastructure Solution 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 58 / 2017 / Challenges in Multi-Site Monitoring

59 Multiple Sites Multiple Connections Typical Solution Standardize on one connection type. Force each site to deal with it. Page 59 / 2017 / Challenges in Multi-Site Monitoring

60 Multiple Sites Multiple Connections Typical Solution Standardize on one connection type. Force each site to deal with it. Recommended Solution Provide multiple connection types. Ethernet WiFi Long-range RF Protocol (ex. Vaisala VaiNet) Match IT connections to the needs of each site. Page 60 / 2017 / Challenges in Multi-Site Monitoring

61 What the solutions have in Common Typical Solutions Applied after the fact and create more problems Increased Administrative Burden Increased Cost and Risk Simple and Secure Multi-Site Solutions System Features NOT workarounds. Built-in scalability Security Administration Time Zones / Language Measurement Parameters Flexible Connectivity Options Page 61 / 2017 / Challenges in Multi-Site Monitoring

62 Path forward for Multi-Site Customers Enterprise Systems will happen to you. High level benefits outweigh site costs To minimize site costs Get involved in system selection early. Use requirements to drive selection. Select the right vendor. Innovative Long History in Measurement Familiarity with GMP customer Solutions that avoid problems. Page 62 / 2017 / Challenges in Multi-Site Monitoring

63 Review Enterprise Systems It is going to happen, so we need to understand them. Multi-Site Challenges Challenges arise when you go multi-site with a single-site system. Customer Types Compare yourself to the examples to predict your challenges. Solutions Not all solutions are created equal. Best solutions are built-in by knowledgeable vendor. Page 63 / 2017 / Challenges in Multi-Site Monitoring

64 Poll #2: Do you want Vaisala to contact you? Yes, I m interested in Loggers Yes, I m interested in Validation Mapping Kit Yes, I m interested in Mapping Services Yes, I m interested in Continuous Monitoring System Yes, I m interested in Process Instrumentation Yes, I m interested in Handheld devices Yes, I m interested in Other Not at this time, thanks. Page 64 / 2017 / Challenges in Multi-Site Monitoring

65 I want more from Vaisala Visit our Life Science Blog Page 65 / 2017 / Challenges in Multi-Site Monitoring

66 Thanks for Attending! Paul Daniel Senior Regulatory Compliance Expert Vaisala, Inc. Page 66 / 2017 / Challenges in Multi-Site Monitoring