Migration to Paperless QC Micro Feat Talecris

FeaturingMarvin Thompson

Manager, Quality Operations

Migration to Paperless QC Micro

www.modatp.com | © 2010 MODA Technology Partners, Inc | More Science. Less Paper.

Co-sponsors

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www.heipha.com www.biotest.com


Today’s Presenters

• Marvin ThompsonManager, Quality Operations [email protected]

• Bob ToalVice President [email protected]

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mailto:[email protected]



60-Minute Agenda

• MODA Overview

• Presentation by Talecris Biotherapeutics

• Software Demo

• Interactive Q&A

• Wrap-up

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A copy of this presentation will be made available to attendees through a follow up email.


Webinar Focus Areas

• Scope of the Talecris QC Micro Program

• Previous Processes & Need for Automation

• Key Requirements for New Solution & Selection Process

• Implementation & Validation

• Current State & Plans for Future

• Real-time Q&A with Marvin Thompson (Talecris)

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Background: MODA

• Provide mobile data acquisition solutions that

automate regulated manufacturing processes

– Focus: Life Sciences Industry

• Headquarters: Wayne, PA (suburban Philadelphia)

• World-wide sales in North America, Europe, and Asia

• Global network of technology and services partners

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MODA Value Proposition

1. More science. Less paper.– Quickly move from paper-intensive

QC Monitoring & Analysis

2. Increase operational efficiency,

improve quality, reduce costs– MODA-EM™ offers mobile computing

technology and advanced visualization tools

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Representative Customers


The Paper-based QC Process

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Example: QC Sampling and Lab Processing

Print sampling

schedule &

labels per EM

SOP

Reconcile

planned

samples with

collected

samples

Close out

sampling

schedule per

EM SOP

Pla

n

Put on sterile

outer garments

and enter

processing

area

Identify area

to collect

samples from

facility map

Collect sample

and affix label

Record date,

time and initials

on paper

schedule and

media

Co

lle

ct

Record

sample receipt

Prepare

samples for

testing. Report

media lot,

equipment,

dilution info

Record

incubation

start date and

time

Incubate

samples

Record

incubation

stop date and

time

Analyze

samples and

record resultsPro

ce

ss

Aggregate

dataTrend results Report results

Revie

w &

A

naly

ze

Investigate

excursionTrends OK? NO

All samples

collected

All samples

accounted

for?

Deliver

sampling

paperwork to

QC Supervisor

Assign

sampling

activities to

QC Analysts

NO

YES

NO

Deliver samples

to Microbiology

or Biochemistry

for processing

YES

NOResults in

range?

Notification of

Alert or Action

YES

YES


The Paperless QC Process

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Example: QC Sampling and Lab Processing. 11 steps removed

Print sampling

schedule &

labels per EM

SOP

Reconcile

planned

samples with

collected

samples

Close out

sampling

schedule per

EM SOP

Pla

n

Put on sterile

outer garments

and enter

processing

area

Identify area

to collect

samples from

facility map

Collect sample

and affix label

Record date,

time and initials

on paper

schedule and

media

Co

lle

ct

Record

sample receipt

Prepare

samples for

testing. Report

media lot,

equipment,

dilution info

Record

incubation

start date and

time

Incubate

samples

Record

incubation

stop date and

time

Analyze

samples and

record resultsPro

ce

ss

Aggregate

dataTrend results Report results

Revie

w &

A

naly

ze

Investigate

excursionTrends OK? NO

All samples

collected

All samples

accounted

for?

Deliver

sampling

paperwork to

QC Supervisor

Assign

sampling

activities to

QC Analysts

NO

YES

NO

Deliver samples

to Microbiology

or Biochemistry

for processing

YES

NOResults in

range?

Notification of

Alert or Action

YES

YES


Paperless Efficiency Example

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Paper 8 hours

– Paperless 4 Hours

= Savings 4 Hours


Automated Reports & Analytics

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MODA QC Solution Vision

Improved Compliance Increased Productivity Expedited Decision Making

Paperless, Automated Laboratory

MODA-EMTM

Mobile Data Acquisition

Flexible Workflow

Integration

On-Demand Analytics

Systems(ERP, LIMS, CAPA)

Devices

Media


Migration to Paperless QC Micro

The Talecris Story

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Quick Facts: Talecris

• Global biotherapeutic and biotechnology company– Discovers, develops and produces critical care treatments for people with

life-threatening disorders in a variety of therapeutic areas

• Headquartered in Research Triangle Park, NC (biotech hub)

– Regional locations in Toronto, Canada, and Frankfurt, Germany

• Primary manufacturing facility in Clayton, NC– Fractionation capacity & contract manufacturing in Melville, NY

• 4,500+ employees worldwide

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Scope of Talecris QC Micro

• EM program consists of monitoring:– All classified facilities (non-aseptic areas)

– All critical utilities: WFI, RO water, Clean

Steam, Compressed Gases

– Aseptic fill facilities and personnel

– Process equipment, in-process product

bioburden, and in-coming raw materials

• Test methods include:– Microbial and particulate testing for facilities

– Microbial and endotoxin testing for process

equipment, in-process product, and raw materials

– Microbial, endotoxin, and USP/EP/JP chemistry

testing of critical utilities

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EM workload: 30,000+ samples tested each month**This does not include any final product release testing

EM lab:24/7 with ~70 employees supporting production ops


Past Processes

• SQL*LIMS Scheduler and Core LIMS were used for

sample scheduling and data entry/reporting

– EM LIMS is a customized version of the standard SQL*LIMS application

– The Core SQL*LIMS was not designed for Environmental Monitoring workflow

• EM Data were distributed over several disparate platforms;

• The following additional systems were being used:

– Excel Spreadsheets—used for recording and trending In-Process sample results

– Microsoft Access DB—used for storing Microbial Identification test results

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Need to Automate

• Data entry and data review

was 100% manual and very

labor intensive.

• Large volume of paperwork

moving through lab and

clerical staff each day.

• Dedicated resources

assigned to data entry and

review into existing data

systems.

• Manual paperwork review

process prior to data entry

results in significant lag times

between test completion and

data entry, approval and

reporting.

• Volume of samples plus

manual process increases

probability of data handling

and paperwork errors.

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Key Rqts: New Solution (1 of 2)

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Paperless EM lifecycleAll sample and testing information is entered directly into computerized system at time of occurrence (“real time”). No reconciliation of transcription process required.

Immediate access to EM resultsProcess owners will have access to test results immediately after interim or final readings due to results being entered directly into system.

Greater flexibility in trending and reporting results

“User Friendly” Designed for use by lab techniciansactually performing EM work.

Automatic notification of excursions throughthe use of system generated emails


Key Rqts: New Solution (2 of 2)

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Mobile work stations for technicians toaccess system from manufacturing cleanrooms in the plant.

Custom and ad hoc reporting for real-timeand historical data analysis.

Notify lab supervisors if scheduled samples are not collected.

Automatic tracking ofsample and EM process.

Scheduling of tasks; barcode label printing; sample collection; incubation; and sample off-testing.

Consolidate multiple EM datasystems into one.

Eliminate Excel spreadsheets and Access databases.

Permit lab supervisors to easily schedule ad hoc & repeat samples.


Selection Process

Researched literature, web sites, industry peers

Attended PDA seminars on EM trending technologies

Several vendors gave hands on demonstrations of their products.

Requested top vendors to come to demonstrate

product solutions to Talecris’ EM group

Selected MODA to automate Talecris EM lab

Acquired senior management approval and funding

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Implementation & Validation

Install MODA:

Dev, QA & Prod

environments

1Configure MODA

with Sample Sites,

Alert/Action levels,

Test Methods,

Sampling Plans, etc.

2Configure &

install custom

reports specified

in System

Requirements

3

Validate system

installation,

functionality &

reports (cGXP)

4System

Documentation:

Requirements, IQ,

OQ, Traceability, Test

Method Verification

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End User

Training

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Current Status

• Validation completed 4th Quarter 2009

• System is operated and maintained by EM personnel

– IS is available for system support and troubleshooting.

• To ensure accurate training, paper based system is

being used concurrently with automated system

– After all employees have demonstrated competency in using new

system, paper-based system will be discontinued (est. May 2010)

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Previous: Raw Data Collection

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Now: Automated Field Data Capture

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Featured: MODA-FDC Cart

• Stainless steel cart

• Ergonomic tablet PC

• Docking station

• Thermal label printer

• Barcode scanner gun

• Proximity reader for RF badges

• Space for equipment

• Space for growth media


Now: Automated Lab Processing

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Benefits

Eliminated data entry and

transcription errors

Real time data entry

EM results available to

process owners faster

Eliminated scheduling errors

Part 11 Compliance

Reduced personnel related

deviations

Enhanced reporting and

analytics capabilities

Instrument integration

No wasting time looking

for paperwork/missing

paperwork

Support for investigation

activities

Fewer corrections and

documentation errors

Quicker reviews

Notifications for deviations

and missed samples

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Path Forward

• Expand MODA users to include manufacturing personnel.

• Reassignment of resources currently associated with data

entry and review of paper based system after that system

is discontinued.

• Integrate particle counters into system to allow automatic

download of nonviable test results directly into MODA.

• Work with media vendors to incorporate bar-coding of

media lot numbers on individual media plates to allow

scanning of media lot number into test records.

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Today’s Cleanroom

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“…cleanroom touch pads or computer terminals that allowfor automated data entry IN THE ROOM.”

“…palm-pilot-type of data collection devices… that can directly download to the computer system and allow fordirect data transfer without risk of contamination.”

“…real time data for many of the chemistry and microbiology tests that must be performed.”

Source: Environmental Monitoring

A Comprehensive Handbook


Today’s QC Micro Lab

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“…analysis and trending of environmental data is essential to aid in the interpretation of process stability and assess overall control performance.”

EM Reports must be “…accurate, traceable, timely, andwell-documented”

Source: Environmental Monitoring

A Comprehensive Handbook


To submit a question, use the “Q&A” feature of WebEx

(bottom right of your screen). If we do not answer a question

online, we will be sure to follow up with an e-mail.

Questions & Answers

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Marvin ThompsonManager, Quality Operations [email protected]

Bob ToalVice President [email protected]




Wrap-up

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Personal Consultation:

Bob Toal, [email protected]

(484) 253-1000 x133

Learn More:

MODA: www.modatp.com

Talecris: www.talecris.com


http://www.modatp.com/

http://www.talecris.com/

Documents

Migration to Paperless QC Micro Feat Talecris