validation basics - gxp webinar · – mostly pharmacy, some labs spread over metro area or region...
TRANSCRIPT
Challenges in Multi-Site Environmental Monitoring
Balancing Standardization and Localizationfor Costs, Risks, and Best Fit
Welcome
Paul DanielSenior Regulatory Compliance ExpertVaisala, Inc.
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Vaisala Team
Speaker:
Paul DanielSr. Regulatory Compliance ExpertVaisala, Inc.
Chat operator:
Janice Bennett-LivingstonMarketing Manager, Life ScienceVaisala, Inc.
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Vaisala in BriefWe 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 OfferingProvides measurement instrumentation, continuous monitoring systems and validation systems for regulated or highly controlled life science environments.
Challenges in Multi-Site Monitoring…When One-Size Doesn’t Fit All
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Enterprise SystemsWhy have a single monitoring system for multiple sites?
Multi-Site ChallengesWhat 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 SpreadMultiple 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: AdministrationHow 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 problemMust 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 SO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
P
SOP SO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
P
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Fix: Super-User
SOP SO
PSO
PSO
PSO
PSO
PSO
PSO
P SOP SO
PSO
PSO
PSO
P
SOP SO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
P
AMY
ARI
ANN
BRENDA
BIANCA
CHEN
CARRIE
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Fix: Super-User
SOP SO
PSO
PSO
PSO
PSO
PSO
PSO
P SOP SO
PSO
PSO
PSO
P
SOP SO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
PSO
P
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 CHARLESBARB
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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: AdministrationTypical 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: AdministrationTypical 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 SolutionTypical 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 SolutionTypical 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 ConnectionsTypical Solution Standardize on one connection type.
– Force each site to deal with it.
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Multiple Sites Multiple ConnectionsTypical 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… LoggersYes, I’m interested in… Validation Mapping KitYes, I’m interested in… Mapping ServicesYes, I’m interested in… Continuous Monitoring SystemYes, I’m interested in… Process InstrumentationYes, I’m interested in… Handheld devicesYes, I’m interested in… OtherNot 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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Paul DanielSenior Regulatory Compliance ExpertVaisala, Inc.
Email: [email protected]
Thanks for Attending!