migration to paperless qc micro feat talecris
TRANSCRIPT
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
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Today’s Presenters
• Marvin ThompsonManager, Quality Operations [email protected]
• Bob ToalVice President [email protected]
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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.
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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
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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
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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
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Paperless Efficiency Example
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Paper 8 hours
– Paperless 4 Hours
= Savings 4 Hours
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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
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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
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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
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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.
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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
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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
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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
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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
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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]
www.modatp.com | © 2010 MODA Technology Partners, Inc | More Science. Less Paper.
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