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Vaisala Team
Speaker: Paul Daniel
- Sr. Regulatory Compliance Expert
Welcome Challenges in Multi-Site Environmental Monitoring - - PowerPoint PPT Presentation
Welcome Challenges in Multi-Site Environmental Monitoring - - PowerPoint PPT Presentation
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.
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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
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Vaisala - Life Science
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 Our Offering Provides measurement instrumentation, continuous monitoring systems and validation systems for regulated or highly controlled life science environments.
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Challenges in Multi-Site Monitoring
…When One-Size Doesn’t Fit All
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- 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?
Goals
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What is an Enterprise System?
- One application
instance on centralized server.
- Many users and sensors
at peripheral sites via LAN.
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- Risk Mitigation
- Cost Savings
- Single Point of Vendor Contact
Why go Enterprise? Benefits
NOTE: This may be inevitable… So get ready!
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- 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.
Why not go Enterprise?
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- 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
Where do the problems come from?
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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
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Challenge 2: Administration
- How do I limit administrative
burden as we add sites?
- Increase efficiency?
- Delegate tasks?
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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?
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Challenge 4: Multiple Site Types
- How to ensure that individual site requirements are met?
- All required parameters should be included without workarounds.
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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?
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- 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.
Poll Slide #1
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- National Warehousers
- Regional Hospitals
- Global Manufacturers
Different Kinds of Customers
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National Warehousers
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- 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
National Warehousers
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Regional Hospitals
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- 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
Regional Hospitals
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Customer 3: Global Manufacturers
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- 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
Global Manufacturers
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Customer Summary Chart
Security Admin Geo Multi-site IT National Warehouser Regional Hospital Global Manufacturer
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Customer Summary Chart
Security Admin Geo Multi-site IT National Warehouser Regional Hospital Global Manufacturer
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- 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
Problem Solving
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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
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Single-Site: AMY
AMY
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Single-Site: AMY shares with ARI
AMY ARI
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Single-Site: System Grows…
AMY ARI
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Single Site: ANN helps out
AMY ARI ANN
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Multi-Site: Sites A and B
AMY ARI ANN BRENDA BIANCA
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Multi-Site: Sites A and B… and C
AMY ARI ANN BRENDA BIANCA CHEN CARRIE
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Fix: Procedural “Don’t Look”
AMY ARI ANN BRENDA BIANCA CHEN CARRIE
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
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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
AMY ARI ANN BRENDA BIANCA CHEN CARRIE
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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
AMY ARI ANN BRENDA BIANCA CHEN CARRIE
(and Ticket System)
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Solution: Site Segregation
AMY ARI ANN BRENDA BIANCA CHEN CARRIE AL CHARLES BARB
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One Step Farther…
AMY ARI ANN BRENDA BIANCA CHEN CARRIE
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- 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”
Security Solution Summary
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Object Level Security: ANN’s View
AMY ARI ANN BRENDA BIANCA CHEN CARRIE
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Object Level Security: AMY’s View
AMY ARI ANN
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- 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”
Security Solution Summary
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The Administration Solution
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Administration Headache Part 1
- 10 complex alarms
- 40 Components
- 20 Thresholds
- 20 Notifications
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Administration Headache Part 2
- 20 complex alarms
- 80 Components
- 40 Thresholds
- 40 Notifications
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Administration Headache Part 2
- 20 complex alarms
- 80 Components
- 40 Thresholds
- 40 Notifications
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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
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Alarm Configuration Analysis
- 20 complex alarms
- 80 Components
- 40 Thresholds
- 40 Notifications
- Use 7 Templates
- Only 4 Thresholds
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Alarm Configuration Analysis
- 20 complex alarms
- 80 Components
- 40 Thresholds
- 40 Notifications
- Use 7 Templates
- Only 4 Thresholds
- Only 3 Notifications
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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
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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?
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- London
UTC +0 Corporate Headquarters
- Paris
UTC +1 Research Facility
- Berlin
UTC +1 Warehouse
- Helsinki
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
Geography Challenge Example
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- London
UTC +0 Corporate Headquarters
- Paris
UTC +1 Research Facility
- Berlin
UTC +1 Warehouse
- Helsinki
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 – Spanish – French – German
Geography Challenge Example
– Portuguese – Swedish – Japanese – Chinese
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Multiple Site Types Solution
- How do we ensure that individual site requirements are met?
- All required parameters must be included without workarounds.
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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.
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- Typical System Sensors
- Temperature (-40°C to +40°C)
- Relative Humidity
- Door Contacts
- Vaisala viewLinc Data Loggers
- Temperature (-196°C to +80°C)
- Relative Humidity
- Door Contacts
- Differential Pressure
- CO2
Multiple Sites need Multiple Parameters
- Import all other parameters
– Custom programming
- Vaporized Hydrogen Peroxide
- Dewpoint
- Barometric Pressure
- Universal Input Loggers
– Standardized Import
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The Multiple Site Types Solution
- Typical Solution
- Pick a system with usual parameters.
- Import unusual parameters with work-arounds.
– Custom code to import data.
– More potential points of failure. – Increased validation effort
- Vaisala Solution
- Offer more parameters than other systems.
– We manufacture the sensors.
- Input specialized measurements via universal loggers.
– Standardized input pathways reduces complexity.
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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?
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Multiple Sites Multiple Connections
- Typical Solution
- Standardize on one connection type.
– Force each site to deal with it.
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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.
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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
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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.
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- 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.
Review
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- 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.
Poll #2: Do you want Vaisala to contact you?
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I want more from Vaisala…
- Visit our Life Science Blog
- https://www.vaisala.com/en/industries-innovation/life-science
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