Pharma&Biotech
MODA™ Solution
Informatics for QC Micro
Automated QC Microbiology Processes
for Regulated Manufacturing
Fully Equipped
« The MODA™ Solution is equipped with hardware,
software, and implementation services required
to get you into production quickly – allowing time
and resources to be directed toward higher value
initiatives and paths to operational excellence. »
Featured: MODA-FDC® Platform
–
–
–
–
–
–
–
–
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
« Mobile, field data capture
for all critical areas. »
Pharma&Biotech – MODA-EM – Informatics for QC Micro
« Eliminate unnecessary time
and cost associated with
paper-based QC methods. »
Capture »
Track »
MODA™ Solution
Mobile Data Acquisition
The MODA™ Solution delivers a comprehensive informatics platform that
automates quality control (QC) processes for all regulated manufacturing
in the Life Sciences industry. As a user of the MODA™ Solution, Lonza has
direct experience with its value – providing improved decision making,
regulatory compliance, and productivity across our own global manufacturing facilities.
The MODA™ Solution integrates with Laboratory Information Management Systems (LIMS) to bridge the communication gap between QC
and production.
A comprehensive Solution
The MODA™ Solution encompasses automation of the full spectrum of QC
activities including environmental monitoring (EM), utility testing, and
product testing. MODA™ Software easily integrates with commonly used
instrumentation and media found in manufacturing facilities, specifically
production and laboratory areas.
Organizations gain timely and accurate QC monitoring by utilizing locationbased scheduling, mobile data collection, and paperless lab processing.
MODA™ Software also delivers on-demand reporting, trending, and visualization capabilities to allow in-depth process analysis and ad hoc queries
by decision makers.
Pharma&Biotech – MODA-EM – Informatics for QC Micro
Components Include
MODA-EM® — Lonza’s flagship software for paperless EM automates your
QC Micro data collection and management (EM, utility, and product testing).
MODA-VIP® — Visual Intelligence Portal provides improved insight into your
manufacturing operation and testing data.
MODA-FDC® — Field Data Capture lets you quickly collect, label (barcode)
and track test samples for EM, utilities, and products at points of sampling
within all critical areas.
Sample Collection Time Reduced 50 %
The typical paper-based process for a sample collection regiment is roughly
about 8 hours per person, per shift. Using the MODA™ Solution for sample
collection, your process time is cut in half to roughly 4 hours per person,
per shift. This savings has significant implications when it is applied to multi
technician, multi-shift operation for a one year period.
70
70
Number of IDs
Results
Trend »
60
50
5
4
40
3
30
25
20
15 16
15
2
10
0
8
6
00 0 0 0
0 0 0 0
6
23
0 0 0 0 0 0 0 00
0 0
00
0 0 0 00 0 0 0 0 0 0 0
00 00 0 0 00 0 0 0 0 00 00
00 0 0 0 0 0
M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M M
1P 5A 8A 2P 0P 9P 2A 3P 2P 5P 1A 9P 8A 9A 5P 6P 8P 1P 0A 6A 0P 4P 7A 1P 1P 7P 5A 2P 4A 5P 3P 1A 1P 4A 4P 7P 8P 1P 1P 2A 9P 4P 1P 7A 1A 8A 4A 4P 5A 5A 6P 4A 9A 5P 5A 6A 1A 6P 3P 1P 8P 7A 9A 0P 6P
8:2 :2 :3 :1 :1 :0 :4 7:4 :1 :0 4:2 :2 :4 7:2 7:4 :4 :4 :3 :0 :5 :0 :3 :5 :0 :0 4:1 :4 :0 :5 :2 :1 8:4 :4 4:1 7:1 :4 :3 7:5 7:5 :5 :2 :2 :3 7:5 :1 :4 0:1 :5 :4 :0 :0 9:1 :3 :1 :2 :2 :3 :0 :2 2:2 :0 :2 :5 :2 :3
:0 :29 :53 :24 :25 :05 :52 :0 :38 :28 :1 :26 :11 :1 :1 :39 :09 :40 :30 :38 :10 :46 :32 :59 :59 :1 :01 :28 :01 :49 :23 :4 :48 :1 :0 :05 :33 :2 :2 :04 :05 :13 :03 :2 :38 :16 :2 :16 :51 :26 :54 :2 :23 :52 :51 :08 :03 :52 :41 :0 :12 :29 :25 :14 :22
12 9 8 9 5 9 3 9 5 11 10 12 9 8 9 9 10 11 10 10 0 4 0 1 0 6 0 2 0 9 0 9 0 2 0 8 06 0 1 0 1 0 3 11 0 5 11 0 2 0 5 10 10 0 1 0 1 0 8 0 4 0 4 0 4 11 0 4 0 2 0 3 10 0 5 0 9 0 9 12 11 10 11 0 1 0 7 0 9 12 0 8 10 1 8 1 5 1 6 2 1 2 6 10 2 3 2 7
09 200 200 200 200 009 009 009 200 200 009 010 010 010/201 201201 201 201 201 201 201 010 201 201 201 010 201 010 201 201 010 010 /201/201 201 201 201 201 010 201 201 201 010 201 201 201 010 010 010 010 201 201 201 010 201 011 201 201 201 201 201 012 201 201
0
/ / / / 2 / / / 2 / / / 2 2 2 2 / / / 2 / 2 / / / / / 2 / /
/
/ / / / / / / 2 / / / 2 / 2 / / 2 2
/
2 / /
2 2 / / 2 2 2 /2
7/ 6 9 2 8 /2 / 8/ 9 9 0/ 1/ 2/ 2 22 15 15 18 3 23 16 8 2/ 13 13 13 3/ 17 8/ 21 23 4/ 3/ 21 22 23 8 03 03 4/ 0 08 27 4/ 18 19 21 8/ 9/ 0/ / 07 08 08 9/ 14 2/ 3 20 14 17 29 6/ 09 13
/1 9/2 9/2 0/2 0/2 /29 /18 /0 2/0 2/0 /1 /1 /1 /2 1/ 2/ 2/ 2/ 2/2 2/ 3/ 3/1 /2 4/ 4/ 1/ /1 5/ /1 5/ 6/ /2 /1 7/ 7/ 7/ 7/2 8/ 8/ /2 8/3 9/ 9/ /0 0/ 0/ 0/ /2 /0 /3 /05 2/ 2/ 2/ /0 2/ /1 5/2 9/ 2/ 4/ 5/ /0 8/ 8/
09 0 0 1 1 10 10 12 1 1 12 01 01 01 0 0 0 0 0 0 0 0 03 0 0 0 05 0 05 0 0 06 07 0 0 0 0 0 0 08 0 0 0 10 1 1 1 10 11 11 12 1 1 1 12 1 01 0 0 1 0 0 08 0 0
Result
Action Level
Alert Level
95th Percentile
99th Percentile
Min. Result
Max. Result
Avg. Result
Sample Data
2
1
1
0
1
Acinetobacter Aspergillus
genomospecies candidus
9
2
1
Aspergillus
glaucus
Aspergillus
parasiticus
2
1
Bacillus
cereus
Enterococcus Escherichia
casselifavus
coli
1
Gram-Cocci
1
Gram-Rods
Visualization Mapping Tool
On-demand Analytics
Enable a correlation of test results with floor plans of your physical facility. This can be easily configured to match the zone classifications on the
processing plant floor. MODA™ Solution is compatible with facility maps
developed with industry standard drawing packages such as AutoCAD®
and Visio®.
Tabular Views such as a Deviation Summary report.
« Gain complete insight
into your manufacturing
operations. »
2
Gram + Cocci Micrococcus
luteus
Species
Trend Reports for user-selected tests and timeframes.
« Quickly access reports and
trends on your quality data –
at the click of a button. »
Visualize »
Featured: MODA-VIP® module
More Science. Less Paper.™
Without MODA™ Solution
By combining automated scheduling, workflows, mobile data acquisition,
device integration, and advanced analytics, the MODA™ Solution delivers
efficiencies across your organization.
Manual, paper-based process steps burden QC Micro programs with paper scheduling, marker labeling of sample media, manual reconciliation,
paper log book entry, and manual notification of deviations. Test results
are stored in shelves of paper binders – a challenge to quickly navigate
during an audit.
QC Departments Are Able To:
–
–
–
–
–
–
–
Automate data collection from devices and people
Eliminate redundant data entry and transcription errors
Gain direct traceability of QC Micro programs
Increase worker efficiency
Improve regulatory compliance
Make sound product quality and release decisions
Quickly advance Green initiatives
Measurable Benefits:
– QC Technicians quickly and accurately collect data in critical areas
– Lab Managers improve process efficiency for scheduling and tracking.
– Supervisors gain immediate, detailed reporting on the production
area to enable sound product release decisions, effective
investigations, and quick response to audits.
– Executive Management can access longer term trend reports to
assess overall program effectiveness.
For Corrective and Preventative Action (CAPA) purposes, building a set of
trend reports can require more than eight weeks. By the time a trend of
activity is developed and recognized, the condition causing the trend is
likely to have changed – making it difficult to support corrective action
activities – and nearly impossible to perform meaningful preventative
actions.
www.lonza.com
www.lonza.com/moda
A Life Sciences Focus
Across the pharmaceutical industry, problems with product safety and
efficacy due to contamination issues make the front page headlines all too
often. The cost of a recall due to real or even a suspected contamination
event is incalculable when one factors in the risk to consumers and the
loss of brand confidence. Lonza is dedicated to helping our clients prevent
incidents like this from ever occurring.
Regulating agencies require comprehensive QC Micro programs to demonstrate that processing areas are under control for potential viable and
non-viable contamination. However, the traditional paper-based QC Micro
processes can be expensive, error-prone, and time and labor-intensive
regardless if they are managed by small biotech companies or large pharmaceutical manufacturers.
Lonza Walkersville, Inc. – Walkersville, MD 21793
Visio is a registered trademark of Microsoft. AutoCAD is a registered
trademarks of Autodesk, Inc. All other trademarks belong to Lonza
or its affiliates or to their respective third party owners. The information contained herein is believed to be correct and corresponds to
the latest state of scientific and technical knowledge. However, no
warranty is made, either expressed or implied, regarding its accuracy
or the results to be obtained from the use of such information and
no warranty is expressed or implied concerning the use of these
products. The buyer assumes all risks of use and/or handling. Any
user must make his own determination and satisfy himself that the
products supplied by Lonza Group Ltd or its affiliates and the information and recommendations given by Lonza Group Ltd or its affiliates
are (i) suitable for intended process or purpose, (ii) in compliance
with environmental, health and safety regulations, and (iii) will not
infringe any third party’s intellectual property rights.
© 2016 Lonza. All rights reserved.
RT-BR013 01/16