Seeq for Pharma- Present and Future PDF.pdf
Seeq for Pharma: Present and Future
Michelle Hart Product Manager Seeq
Paolo Braiuca Pharma Industry Principal Seeq
©2024 – Seeq Corporation | 2©2024 – Seeq Corporation | 2
A manufacturing intelligence platform to process and analyze industrial time-series data.
Seeq allows to: - Visualize, Search, Contextualize, Cleanse Data - Find patterns, establish boundaries and conditions - Perform calculations, modelling and Machine Learning - Monitor in (near) real time and predict outcomes - Build automatically updating dashboards and reports - Operationalize data science algorithms and scripts - Scale insights across the organization - And a lot more!
It seamlessly connects to multiple data sources, such as process historians, LIMS, data lakes, and to external data science and business intelligence tools. It does not need any change to data storage setup.
What is Seeq?
A computer with a graph on it
Description automatically generated
Watch the product overview
https://www.seeq.com/product/our_offerings/ https://www.seeq.com/product/our_offerings/
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Seeq is a unified operational insights hub that is mission critical for enterprise decision-making
Data
Feedback
Insights DataOn Premises
Data Sources Cloud Data
Sources
Historians, LIMS, MES, Data Lakes, etc.
Your Data
Subject Matter Expert +
Your Expertise
Low / No Code Advanced Analytics & Monitoring w/ AI
Cloud Services Integrations
Your Workflows
Works with & improves performance of existing investments
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Welcome to the Pharmaceutical industry, where everything is 10 years
behind and moves like molasses
INDUSTRY VETERAN “Top 10 Pharma Company” Seeq customer
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Seeq’s early days Time series data: biggest untapped potential in the process industry
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….and …
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Envisioning the Platform’s Potential
Root cause analysis
Exploratory analytics
Process quality monitoring
Performance monitoring + reporting
APR, CPV Reliability
management
AH-HOC ANALYTICS FULLY FLEDGE SOLUTIONS
FOR CRITICAL ROUTINE PROCESSES
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Evolving into a Pharma-friendly Platform
Seeq becoming more and
more suitable for application
in pharmaceuticals
development and
manufacturing
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Learned from
Users
Feature requests
User Research
Users’ feedback
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What is Seeq applied to today?
Process Development Process Monitoring & Management
Assets Monitoring & Management
Operational Efficiency & Supply Chain
CPP Identification
Process Optimization
Tech Transfer
OEE – Continuous Improvement Analytics (Performance Metrics, Increase Equipment Availability)
Data Insight Into Planning Scheduling
Anomaly Detection And Root Cause Analysis
Ensure Quality Compliance (CPV, APR, Batch Reporting)
Predictive Modeling & Continuous Improvement Analytics
Anomaly Detection And Root Cause Analysis
Predictive Maintenance
Industrial Enterprise Monitoring
R&D Drug Substance Manufacturing
Drug Product Manufacturing
Engineering (Facilities / Utilities /
Maintenance)
Drug Product Manufacturing
Drug Substance Manufacturing
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But what about validation?
• Customers started to validate early on!
• “Compliance features” the most requested since early days
• Most Pharmaceutical Customers have validated Seeq instances
• Long and successful audit history
• Hearing it louder: “we want Seeq in GMP decision making!”
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Pharma Functionality in Seeq - History
2021
Audit Trail
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Pharma Functionality in Seeq - History
2021 2022
Audit Trail Compare View
Many features expanding use of Capsule Properties
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Pharma Functionality in Seeq - History
2021 2022
Audit Trail Compare View
2023
Many features expanding use of Capsule Properties
Expanded functionality for Conditions on the trend
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Pharma Functionality in Seeq - History
2021 2022
Audit Trail Compare View
Administrator Capabilities can
be granted separately
20242023
Many features expanding use of Capsule Properties
Expanded functionality for Conditions on the trend
Improved Condition Tables and Charts
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Pharma Functionality in Seeq - History
2021 2022
Audit Trail Compare View
Administrator Capabilities can
be granted separately
20242023
Many features expanding use of Capsule Properties
Expanded functionality for Conditions on the trend
Improved Condition Tables and Charts
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Why Seeq Pharma Suite?
• Easier for customers to validate Seeq as a platform and the analytics solutions developed in Seeq
• Enables GMP-decisions use cases • Process-related and quality management solutions • Higher value • Business-critical
• Fits customer journey Pharma’s Vendor Qualification needs
©2024 – Seeq Corporation
Vendor Selection
•Qualification requirements and Business needs
Vendor Qualification
•Assessment of vendor processes and QM to ensure GMP compliance
Quality agreement
•Covered by SLA
Auditing
•Initial audit for capabilities assessment and qualification
Ongoing Performance Evaluation
•Includes follow up audits at regular intervals
A product designed to respond to unique industry requirements
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What is Seeq Pharma Analytics & AI Suite? 17
Analytics Change Management
• Analysis Locking
• Analysis Versioning
• Readable Audit
Regulatory Compliant Support
• SaaS Update Coordination
• Seeq Additional Tenant
• Access to Pharma Trust Center
• Right to Audit
Pharma Specific Needs and Benefits
• Seeq Pharma Community of Practice
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Analytics Change Management
Why? • Makes it easier to use Seeq in validated environments • Helps with enterprise rollouts and consistency across lines, sites, etc.
What? • Ensures no one can make changes to an analysis when it is locked • Allows versions to be linked together so updates can be made • Changes to calculations are tracked
How? • Workbench Analysis Locking • Workbench Analysis Versioning • Readable Audit Trail
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Recommended setup for Validation 20
Use folders in the Corporate drive for each stage in the approval process
Use Access Control on the folders to control who can make changes at each step in the process
Lock Analyses once changes should no longer be made
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Regulatory Compliant Upgrades
©2024 – Seeq Corporation
PRODUCTION SERVER Validated
TEST SERVER “Additional tenant”
New version Release and Test
Report
Version updated
Tests and approval
Production environment
update
Approval Communication
Default update cycle time: Quarterly
Flexibility to accommodate customers’ requirements
SLA language defines Update Coordination mechanism
Controlled update mechanisms – fits industry standards
Lower risk of unnoticed bugs and faster fixes
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Right to Audit • Documentation and resources for the initial quality audit
• Periodic follow-up audits
Access to Pharma area of the Trust Center • Dedicated portal for Pharma documentation
• Documentation to assist validation processes • Quarterly Regulatory Release Notes and Testing
Pharma Community of Practice • Ability to network with other Seeq users in the industry
• Access to virtual and in-person events
• Early visibility of new features and opportunity to participate in user research
• Private forum area on seeq.org
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Conclusions 23
From what I can see, you guys tick all the boxesThis is what you need to have
to be credible in this industry
This is pretty pro-active and goes far beyond what a lot of companies (like #$%^&£) that claim to have Pharma solutions currently provide. It shows
they have a real understanding of the industry.
Our GMP validated processes that use Seeq have passed
Swissmedic review!
ZERO critical findings in the history of Seeq audits. Most audits with no findings at all!
Default Section Slide 1: Seeq for Pharma: Present and Future Slide 2: What is Seeq? Slide 3 Slide 4: Seeq is a unified operational insights hub that is mission critical for enterprise decision-making Slide 5 Slide 6: Seeq’s early days Slide 7: Envisioning the Platform’s Potential Slide 8: Evolving into a Pharma-friendly Platform Slide 9: What is Seeq applied to today? Slide 10: But what about validation? Slide 11: Pharma Functionality in Seeq - History Slide 12: Pharma Functionality in Seeq - History Slide 13: Pharma Functionality in Seeq - History Slide 14: Pharma Functionality in Seeq - History Slide 15: Pharma Functionality in Seeq - History Slide 16: Why Seeq Pharma Suite? Slide 17: What is Seeq Pharma Analytics & AI Suite? Slide 18: Analytics Change Management Slide 19 Slide 20: Recommended setup for Validation Slide 21: Regulatory Compliant Upgrades Slide 22 Slide 23: Conclusions