lab of the future program (iqc) -...

Lab of the Future Program (iQC)

Feb 2018Christy MountsDirector, Global QC Systems and Services

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

7

Beginning of our Journey – Smart-QC

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

Forecast

+20%

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

14

Initial Assessment

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

18

Designing the Future

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

21

Future State – What does

it look like?

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

24

LES

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

27

Electronic Lab Notebook

(ELN)

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).

Advantages of KNEAT

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


Biogen 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

Acknowledgements

37

• Melissa Seymour, VP, QC

• Amin Abujoub, VP, QA

• Besufekad Alemayehu, VP, IT

• Mike Stroz, Director, IT

• Bill Rusin, Sr. Mgr, IT

• Jeremy Slessman, Sr. Mgr, QC

• Sachin Patel, Mgr, QC

• Gretchen LaPan, Mgr, QC

• Megan Mancini, Mgr, QC