Validation Basics - GxP Webinar · – Mostly Pharmacy, Some Labs Spread over Metro Area or Region Often closed architecture ... Helsinki UTC +2 Cleanroom Vaisala Technology Solution

Challenges in Multi-Site Environmental Monitoring

Balancing Standardization and Localizationfor Costs, Risks, and Best Fit

Welcome

Paul DanielSenior Regulatory Compliance ExpertVaisala, Inc.

Page 2 / 2017 / Challenges in Multi-Site Monitoring

Vaisala Team

Speaker:

Paul DanielSr. Regulatory Compliance ExpertVaisala, Inc.

Chat operator:

Janice Bennett-LivingstonMarketing Manager, Life ScienceVaisala, Inc.


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


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


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


What is an Enterprise System?

One application instance on centralized server.

Many users and sensors at peripheral sites via LAN.


Risk Mitigation

Cost Savings

Single Point of Vendor Contact

Why go Enterprise? Benefits

NOTE: This may be inevitable… So get ready!


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?


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?


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


Challenge 2: AdministrationHow do I limit administrative

burden as we add sites? Increase efficiency? Delegate tasks?


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?


Challenge 4: Multiple Site Types

How to ensure that individual site requirements are met? All required parameters should be included without workarounds.


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?


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


National Warehousers

Regional Hospitals

Global Manufacturers

Different Kinds of Customers




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


https://www.vaisala.com/en/case/mckesson-specialty-health-achieves-over-100-audits-without-single-observation

http://www.vaisala.fi/Vaisala%20Documents/Success%20Stories/CEN_LSH_Warehouse_Monitoring_Success_Story.pdf

https://www.vaisala.com/en/case/australias-leading-pharmacy-service-provider-safeguards-products-gap-free-data-fail-safe-alarming


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

Regional Hospitals

http://www.vaisala.de/Vaisala%20Documents/Success%20Stories/VIM-G%20Pediatric%20Research%20Hospital%20Success%20Story_B211665EN-A_High.pdf

https://www.vaisala.com/en/case/reliable-environmental-monitoring-system-satisfies-clinical-trial-sponsors-safeguards-life-enhancing-research

http://www.vaisala.fi/Vaisala%20Documents/Success%20Stories/VIM-G%20LifeSharing%20Tissue%20Storage%20Success%20Story_B211663EN-A_High.pdf


Customer 3: 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

Global Manufacturers

https://en.wikipedia.org/wiki/List_of_largest_biotechnology_&_pharmaceutical_companies

https://www.vaisala.com/sites/default/files/documents/CEN-LSC-PCI-selects-Vaisala-Continuous-Monitoring-System-to-ensure-quality.pdf


Customer Summary Chart

Security

Admin

Geo

Multi-site

IT

National Warehouser

Regional Hospital

Global Manufacturer


Customer Summary Chart

Security

Admin

Geo

Multi-site

IT

National Warehouser

Regional Hospital

Global Manufacturer


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


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


Single-Site: AMY

AMY


Single-Site: AMY shares with ARI

AMY

ARI


Single-Site: System Grows…

AMY

ARI


Single Site: ANN helps out

AMY

ARI

ANN


Multi-Site: Sites A and B

AMY

ARI

ANN

BRENDA

BIANCA


Multi-Site: Sites A and B… and C

AMY

ARI

ANN

BRENDA

BIANCA

CHEN

CARRIE


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


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


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)


Solution: Site Segregation

AMY

ARI

ANN

BRENDA

BIANCA

CHEN

CARRIE

AL CHARLESBARB


One Step Farther…

AMY

ARI

ANN

BRENDA

BIANCA

CHEN

CARRIE


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


Object Level Security: ANN’s View

AMY

ARI

ANN

BRENDA

BIANCA

CHEN

CARRIE


Object Level Security: AMY’s View

AMY

ARI

ANN


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


The Administration Solution


Administration Headache Part 1

10 complex alarms

40 Components 20 Thresholds 20 Notifications



20 complex alarms




20 complex alarms



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


Alarm Configuration Analysis

20 complex alarms


Use 7 Templates Only 4 Thresholds


Alarm Configuration Analysis

20 complex alarms


Use 7 Templates Only 4 Thresholds Only 3 Notifications


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


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?


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


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


Multiple Site Types Solution

How do we ensure that individual site requirements are met? All required parameters must be included without workarounds.


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.


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


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.


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?


Multiple Sites Multiple ConnectionsTypical Solution Standardize on one connection type.

– Force each site to deal with it.


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.


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


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.


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


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?


I want more from Vaisala…Visit our Life Science Blog https://www.vaisala.com/en/industries-innovation/life-science

https://www.vaisala.com/en/industries-innovation/life-science


Paul DanielSenior Regulatory Compliance ExpertVaisala, Inc.

Email: [email protected]

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