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What is the Lab of the Future?
The Lab of the Future is a QC multi-year program to:
• Achieve the vision of building a state of the art Quality Control
organization
• Increase QC efficiency, reliability, and scalability
• Empower collaboration across various functions within and
outside QC
• Enable Biogen’s operations of the future and Next Generation
LSM
Started with a Vision
3
“To be the most innovative, intelligent and integrated quality
control organization; defining state of the art for the industry”
Lab of the Future
ReliabilityImprove data integrity with systems and
instrument integration
Provide a clean and transparent chain of custody
ScalabilityIncrease the number of testing with the same
amount of resources
Operational EfficiencyReduce non-value added work associated with
testing, verification and manual operations
Lab of the Future Benefits
Test Method
Development
Manufacturing
Excellence
Laboratory
Execution
System
Asset/Training
Management
Lab of the Future Capabilities
Comprehensive
Sample
Management
Specification
Management
Lab Operation
Planning
Lab
Analytics
The Journey
Jan 2015
iQC Vision
socialized
May 2015
Consulting
Assessment
Begins
Sep 2015
Funding
Approval &
Kick-Off
Requirements
Gathering
Sep 2013
May 2016
Vendor
Selection
complete
2018-2020
Release 2-4 LES
Jan 2016
Vendor
RFP’s
Submitted
June 2016
LES Project
Kick off
Jan 2017
Jan-Dec
2017
LES
Jan 2018
UAT LES
Mar 2018
Release 1
What is SmartQC
8
Determine Resource Requirements for a given Forecast (Short Term and Long Term: Week, Month, Quarter, Year.)
Additional Resources, Shift Structure, Allocation (internal / External), Cross Training, Special Project, Campaign Optimization etc.
Do I have sufficient resources ? (CAPACITY)
How do we Monitor / Report / KPI ?(DASHBOARD / REPORTS)
Optimized Lab Performance based on Business Needs (Sample Arrival, Due Dates & Resources availability)
Track your COQ & Efficiency Improvements Opportunities, Service Level, Backlog and more
How do we optimize our performance ? (SCHEDULING)
PLAN
SCHEDULE
MONITOR
SHORT/LONG TERM
OPTIMIZE
REPORTS & KPI
“WHAT IF”
ACTION PLAN
Planning and Scheduling
9
• Planning and Scheduling was done differently in each lab
› Each lab 1-2 people managing the weekly schedule
› The primary system used was Excel or white boards
• Our TAT were inconsistent
› 2013: Target 45 days and meeting 60% of time
• We made a major shift in our approach in QC
› We created a planning organization that reported directly to the head of QC.
› Each site had one planner that supported all labs at that site
› We assessed the need for an automated planning tool to better equip our new
organization with the recipe for success
• We selected Smart-QC
› March 2013: We kicked off the project
› September 2013: Implemented SmartQC at all 3 sites for Bioassay and Chemistry
› 2014: Continued to roll out the remaining labs
Cycle Time Reduction
10
• In 2017, ALL of our sites RELEASE is below
21 days and OVERALL we have cut our
cycle time by more than 33%
• Key focus areas:
› Optimize our scheduling by having
Smart-QC algorithm perform automated
process that helps optimize our
campaigning practice
› Understanding of our NON-Test activities
› Reduce Non-Value added by actually
seeing the data (i.e., excessive meetings)
› Forecasting and Optimizing our network
between the commercial sites
» Moving samples from one site to another
based on workload
» Sending samples to CLOs
Smart QC Summary
12
• A combination of organizational structure, increased focus and
automation
› We managed to address the most critical aspect of QC
laboratories operational excellence which is effective planning
and scheduling processes.
• What we have changed:
» Hiring new resources is data driven
» Level load the work across sites, cross training, etc.
» Yearly and Quarterly planning/forecasting review with QLT
» Touchscreen monitors in each lab office area
» Weekly overview of KPI
» Change the culture of our team
15
We executed a comprehensive functional, technical, and business
assessment to uncover key insights that can drive recommendations
Conducted 75+ interviews of primary
research across multiple functions
in QC, QA, TD, IT, Manufacturing,
and MS
Considered all major sites as well as
external labs and other country labsPerformed research on biopharma
best practices
Engaged with key stakeholders from SCALE, TD LIMS, and NGA
Undertook technology market scan
of LIMS and ELN vendors
Utilized consulting resources to
structure the analysis and also
gather key industry insights
Defined critical QC system interfaces in the enterprise architecture
Reviewed secondary research on
financial benchmarks
Collected and analyzed Biogen data
on resources, activity, forecasts,
financials in order to build the
business case
Test Methods
Instrument Systems
(e.g., Empower)
NCs
(TRACKWISE)
LMS
(IsoTrain)MYCIMS PDH
QC LIMS
▪ Sample Plans
▪ Print Sample Labels
▪ Test Method Documents
▪ Paper Test Records
Specifications
Process Control Systems
(e.g., Delta V)
Manufacturing
▪ Paper MBR
▪ Paper BHR
▪ Paper Test Results
EAM
(Infor)
Method Documents
Configure Specs
Item
Master
Item MasterSpec & Method Documents
Test Results
Sample Login
Sample
Lot
Lot
Disposition
Instrument
Status
Training
Certs
Record
OOS/NC
OOS/NC Status
Samples Manual Entry
TD LIMS
Test Results
Sample Labels
Sample
Login
Test Results
Received
Lot
New
Lot
Receiving QC
ERP (R12)
The as-is state consists of standalone systems, significant manual
effort and data duplication
Discoverant Smart QC
Lab Execution System (LES)
Specifications
Methods
Lab Execution System Diagram
Instrument Control Systems
(e.g., Empower)
LIMSElectronic Lab
Notebook (ELN)
Sample Manager
Specifications
Management
Smart QC Resource Manager
Reagent Manager
NCs
(TRACKWISE)
Resource Mgmt.
(EAM, LMS,..)Supply Chain (ERP, MES)
43 7 8 11
An improved and scalable solution will build key capabilities
System guided method execution and
electronic transfer of data enabling review by
exception
Single sources of truth for specifications,
methods, and sample plans
Difficult sample tracking, standard
tracking, and chain of custody
procedures
Enable testing at any site through clear
sample chain of custody and 100% reliability
of sample status and location
Reliance on an abundance of manual
processes and data managementReal-time and automated compliance
providing streamlined Quality review and rapid
release
Current State Gaps Future State Capabilities
Multiple sources of truth for guiding
procedures, specifications, etc.
Seamless Integration with Oracle, Agile, and
MES enabling Next Generation Operations
with APCCurrently unable to integrate major
processes and systems within the supply
chain
Key resource integrations (Instruments,
Analyst Training, etc.) with systemic
enforcement of business processes
Automatic population of analytical data into
regulatory submissions and annual product
reviews
Overly-customized LIMS prevents the
use of key out-of-the box functionality
and prevents upgrading to implement
new capabilities
NGA
Benefits
Our focus is on delivering value in the
following benefit areas
▪ Reducing inefficiencies in analyst and reviewer time.
▪ Improvements in sample management.
▪ Automation in TD to QC method transfer.
▪ Reduction in duplicate work of entering sample management
data in multiple systems.
▪ Primary system for Manufacturing Associate will be MES.
▪ Reduction in incidence of errors leading to rework and
deviations.
▪ Support resources that manage CLOs and enter data into
LIMS.
▪ Reduce necessity for ongoing current system fixes.
▪ Leverage “out of the box” capabilities rather than
customization.
▪ Reduce time for required inventory due to reduced QC
cycle time and improved QC cycle reliability.
▪ Optimizing equipment and reagent use.
▪ Visibility and forecasting automation, improving site planner
function.
Efficiency: Cost
Avoidance
Cost of Compliance
COGS (Direct)
Total Cost of
Ownership
Efficiency: Cost
Savings
Outsourcing /
Capacity
Benefit Category Description
Identified 8 key initiatives to deliver a series of business benefits and
new capabilities to achieve the vision
Capability Description
1 Lab Execution System
• Define test methods / analytical procedures in a structured form that can be interpreted and
executed by LabWare
• Enable ELN to guide Lab Technicians through the test methods and create an electronic test
record for results and resources used
2QC Comprehensive
Sample Management
• Provide clear, reliable chain of custody for all samples managed and tested by QC
• Manage samples from pickup through transfer to lab, aliquot, storage, and shipment to external
labs
3Specifications
Management
• One source of truth with one system for management
• Internal Grade Specification- global testing
4 Manufacturing Excellence• Integrate with MES for In-process and material testing
• Defined service model for sample plans
• Integrate with Oracle to supply CofA data for released batches
5Asset/Training
Management
• Manage Reagent and Standards used in QC Lab operations.
• Subscribe to resource management systems to verify resource qualifications and status prior to
use (e.g., EAM, LMS)
6 Test Method Development• Improve the transfer of scientific methods to operations to support repeatable execution of
methods at scale
• Library of test methods for TD and QC
7QC Lab Operations
Planning
• Efficient demand management for QC services
• Dynamic scheduling that facilitates adjustments to plan based on priority, resource status,
regulatory approvals
• Two-way Integration with LES
8 QC Lab Analytics• Population of Off-line Data Store (ODS) with Test Execution Records
• Develop pre-defined analytical reports and dashboards
• Population of regulatory submissions and annual product reviews
Methods
The to-be state is an iQC platform that provides a Lab Execution
System
NCs
(TRACKWISE)
Resource Mgmt.
(EAM, LMS,..)BRIMS ERP (Oracle R12)
Lab Execution System
Integration Platform (Enterprise Services Bus)
2 43 7
43
18
7 8
12
11
12
Integrations
1. Item Master
2. Market Approvals
3. Test Request (Sample)
4. Test Response (Result)
5. Production Request
6. Production Response
7. Resource Master
8. Resource Status
9. Material Lot
10. Lot Status
11. Non-conformance
12. NC Status & Disposition
Specifications
Process Control Systems
(e.g., Delta V)
NGA - Manufacturing Execution System
65 7 8 112
1
1 65
43
TD & AT
(Methods)
10
911
10
9
PDH & PLM
2
1
2
10
9
• QC Sample Management
• Reagent Management
• Test Method Execution
• Material, Drug Substance, Drug
Product Testing
• Stability Testing
• Environmental Testing
• Ad-hoc Sample Testing
• Guided, paperless execution of
production requests:
Commercial production
Clinical production
Experimental / process validation batches
• Electronic Batch Records
Instrument Systems
(e.g., Empower)Discoverant Smart QC
Lab Execution System
The foundation of Biogen’s labs of the future
• Implement a new Lab Execution System (LES) and associated key
capabilities over the next 4 years
• A new LabWare 7 LIMS + Electronic Lab Notebook (ELN) platform
redesigned to enable guided method execution
• Leverage lessons learned from existing implementation, utilize
components from the current system, when appropriate, and
implement best in class industry practices
• Focus on out-of-box functionality with less customization (90/10)
• Critical to fulfilling the Next Generation Operations for Manufacturing
First 2 initiatives will significantly improve the QC
capabilities, efficiency and level of service provided
Implement Labware v7 ELN and LIMS for QC Labs
capable of:
• System guided execution of test methods and
review by exception
• Automatic verification of reagents and
equipment,
• Structured specifications
• Manage reagents and buffers (production, expiry,
etc.)
• Integrate with Mfg and Supply Chain IT systems
Manage samples taken by supply chain customers from
pickup through test results:
• Dispatch to appropriate lab for testing
• Manage transfer / shipment of samples
• Maintain electronic Chain of Custody records for
each sample.
1. Lab Execution System 2. Comprehensive Sample Management
ELN Guided Execution
Methodology
• Intertwining the actual procedure and its result recording all in the same area within ELN
• Controlling what part of the procedure and what results the user sees at any moment in time
• Confirming all necessary results have been recorded before allowing the user to move forward
• Instrument Integration- Not just bringing in individual results, but representing the actual raw data dump from an instrument
Intertwining Procedure and Results
• By merging the procedure text with the results the user only needs
access to one system: LabWare LIMS ELN
LES Summary
30
Implement a new Lab Execution System (LES) - Labware 7 LIMS +
ELN with a focus on out-of-box functionality with less customization
Build and improve key business capabilities including guided method
execution and QC comprehensive sample management
iQC This is a QC-driven project but will provide substantial benefit to
Quality, PO&T, and Biogen and enable the full vision of Next
Generation LSM and Biogen’s operations of the future
Integration with other program and instruments will be a fundamental
component to achieve the future vision of the iQC
What is KNEAT?
KNEAT is an electronic Global Validation Life Cycle
Management System :
o Stores information about legacy validation protocols
o Tracks the validation status of in-progress validation protocols
o Performs electronic protocol generation and execution
o Records protocol test incidents
o Stores related documents and summary reports
High Level Objectives of KNEAT for QC
• Transform the AIV documentation process from paper based
to electronic format
• Develop a dedicated workspace for Analytical Instrument
Validation (AIV) for Global QC and Manufacturing instrument
lifecycle management.
• Eliminate waste (e.g., non value added activities such as
manually routing documents for review and approval in
multiple systems, redundant authoring/review).
Document Hierarchy
Validation Plan (VP)
Requirements Specification (RS)
Vendor IQOQ Biogen IQOQ Biogen PQ
Validation Summary Report (VSR)
Vendor IQOQ Execution
Biogen IQOQ Execution
Biogen PQ Execution
Leveraged Documents: May be applicable across sites for
equivalent/identical systems
Can cover Multiple Sytems
Regulatory Requirements
Assessment (RRA)
Validation Plan (VP)
User Requirements Specification (URS)
Vendor IQOQPQ Protocol Pre-
Approval (VPA)
Biogen IQOQ Biogen PQ
Validation Summary Report (VSR)
Leveraged Documents: May be applicable across sites for equivalent/identical systems
Vendor IQOQ Execution
Biogen IQOQ Execution
Vendor IQOQ Execution
Vendor Protocol Report (VPR)-
execution post approval
Covers a Single System
Legacy (Manual) Process Current Electronic Process
KEY POINT: WHAT we do for AIV is not changing but we are adapting HOW we do it
Kneat Summary/Benefits
• Transform the Analytical Instrument Validation (AIV) process from
paper based to fully electronic system process complete with
integrated test execution and reporting
• Cross site standardization of the QC Asset Lifecycle Management
process
• Eliminate non value added process activities and leverage previous
validation information across all sites
• Establish efficient real time visibility into lab asset status and
records
• Improve resource productivity and reduce cycle time for new
equipment onboarding
o Manufacturing saw a 64% decrease in Protocol Life Cycle Duration
▪ QC is currently calculating their efficiency numbers