LABELMANAGEMENTWITH SAP®INTEGRATION

Vetter Pharma-Fertigung
GmbH & Co. KG

LABELING SOLUTIONS FOR PROFESSIONALSSAP® Labelmanagement from OPAL and BarTender® label softwarefrom Seagull Scientific ensure flawless processes at Vetter, a leading
provider of pharmaceutical services.

GMP-compliant label printing at Vetter, a leading global provider of pharmaceutical services
Accurate, traceable labeling during the clinical development, manufacturing and packaging of syringes andcartridges is crucial to patient safety. Since 2012, Vetter Pharma has used SAP®-integrated Labelmanagement

Printing Solutionsoftware, which includes Seagull Scientific's BarTender® software, from AutoID specialists OPAL.
The result:Top-quality,compliantlabelingprocesses.
new system has realizedenormous
Top-quality,compliant
labeling
processes
with“Ourthe Labelmanagement
solutionanfrom
OPAL. increase inquality. The OPAL and BarTender® solution ensures correct GMP version creation for automated label printing
processes, with a transparent audit trail captured along the entire processing chain. We plan further integration inthese processes as part of our ongoing serialization projects,” said Vetter’s manager responsible for SAP® keyuser production. Company
 Vetter Pharma-Fertigung GmbH & Co. KG
 Founded in 1950
 Employees: 3.300 (Europa and USA) www.vetter-pharma.com

Case Study

SectorAt a glance PharmaceuticalChallenges
 Integration of Labelmanagement-software in SAP®
 Conversion of 500 existing label layouts
 GMP-compliant data content for labeling and version creation
 Flexible printer incorporation
 Integration of different numbering and serialization systems

Vetter Pharma-Fertigung
GmbH &with
Co. Vetter`s
KG is a leading
service provider for clinicalprinting program Integration
bespokeglobalSAP®pharmaceuticaldevelopment and commercial production of parenteral medications. The company specializes in the aseptic fillingof syringes, cartridges
and vials. Vetter manages the entire product life cycle in its processes, supplying
Benefits
pharmaceutical and bio-technology companies throughout the global market with services including pre-clinicalUser-friendly
operation
development and regulatory
approval.
Overall, the company employs about 3,300 people in Europe and the USA.
Stable, easy-to-use
SAP® Vetter the global market leader in the pre-filled
Annual productionof approximately
180 application
million unitsinmakes Flexible labeling processes and printer incorporation
injection system sector.
 Quality improvements through automatic sourcing of variable data Scalable solution
 Incorporation of serialization
OPAL Labelmanagement for SAP®

www.opal-holding.com

GMP-compliant label printing at Vetter, a leading global provider of pharmaceutical services
GMP-compliant label printing at Vetter, a leading global provider of pharmaceutical services

Accurate, traceable labeling during the clinical development, manufacturing and packaging of syringes and®
-integrated
Labelmanagement
cartridgestraceable
is cruciallabelingto patientsafety.
Since 2012,
Vetter Pharma
has usedandSAPpackaging
Accurate,duringthe clinicaldevelopment,
manufacturingof syringes
and®
software,is which
Seagull
BarTender
software,specialists OPAL.
cartridges
crucialincludes
to patient
safety.Scientific's
Since 2012,
Vetter Pharma
hasfrom
usedAutoID
SAP®-integrated
Labelmanagement

The result:Top-quality,compliantScientific'slabeling processes.
new system
has realized
an enormous
software,which
includes Seagull
BarTender®“Oursoftware,from AutoID
specialists
OPAL. increase in®
solutionensures“Ourcorrectnew
GMPversion
printing
OPAL andcompliantBarTenderlabeling
Thequality.
result:TheTop-quality,processes.
systemhascreation
realizedforanautomatedenormous label
increase
inprocesses,with aandtransparent® trail captured along the entire processing chain. We plan further integration inquality.
The OPAL
BarTenderaudit
solution ensures correct GMP version creation for automated label printing
these processes
as part of ouraudit
ongoing
serialization
Vetter’s chain.
manager
SAP® keyin
processes,with a transparent
trail captured
alongprojects,”
the entiresaid
processing
Weresponsible
plan furtherforintegration
userprocesses
production.as part of our ongoing serialization projects,” said Vetter’s manager responsible for SAP® key
theseuser production.

Case
Study
Case
Study

Vetter Pharma-Fertigung GmbH & Co. KG is a leading global pharmaceutical service provider for clinicaldevelopment
and commercial
medications.
The company
the aseptic filling
VetterPharma-Fertigung
GmbH &production
Co. KG isofa parenteralleading global
pharmaceuticalservice specializes
provider forinclinicalof syringes, andcartridges
and vials.
Vetter ofmanages
the medications.
entire productThelifecompany
cycle in itsspecializes
processes,in supplying
development
commercialproduction
parenteralthe aseptic fillingand bio-technology
the global
services includingofpharmaceuticalsyringes, cartridges
and vials. Vettercompanies
managesthroughout
the entire productlife market
cycle inwith
its processes,
supplyingpre-clinicaldevelopment andapproval.
Overall,throughout
the company
employs
aboutwith
3,300
peoplein Europeand the USA.
pharmaceuticaland regulatory
bio-technology
companies
the global
marketservices
includingpre-clinical
Annual productionof approximately
millionmakes
Vetter about
the global
marketin theandpre-filled
development
and regulatory
approval.180
Overall,the unitscompanyemploys
3,300
peopleleader
in Europethe USA.
injectionsystem ofsector.
Annualproduction
approximately 180 million units makes Vetter the global market leader in the pre-filled
injection system sector.

OPAL Labelmanagement for SAP®

www.opal-holding.com

GMP-compliant label printing at Vetter, a leading global provider of pharmaceutical services
About 2,000 cartons packed with injection products leave the facility in Ravensburg every day. Every carton isAccurate, traceable labeling during the clinical development, manufacturing and packaging of syringes andgiven its own shipping label, which adds up to about 450,000 shipping labels produced annually. “We arecartridges is crucial to patient safety. Since 2012, Vetter Pharma has used SAP®-integrated Labelmanagement
contract manufacturers, which means that we do not provide medication directly to the market ourselves, butsoftware, which includes Seagull Scientific's BarTender® software, from AutoID specialists OPAL.
simply deliver the finished products to our customers, the pharmaceutical companies. Our customers determine
The result: Top-quality, compliant labeling processes. “Our new system has realized an enormous increase inhow the labels are created — each customer needs specific information on the label for its own subsequent
GMP version creation for automated label printingquality. The OPAL and BarTender® solution ensures correct
processing work,” said Vetter’s SAP® key user production manager. The labels produced by Vetter must
processes, with a transparent audit trail captured along the entire processing chain. We plan further integration inaccommodate different layouts, logos and fonts. 1D Barcodes and Data Matrix codes contain a range of variable
these processes as part of our ongoing serialization projects,” said Vetter’s manager responsible for SAP® keydetails, including batch number, expiration date, customer material numbers and regulation-mandated serialization
user production.
schemes.

Case Study

Case Study

Vetter Pharma-Fertigung GmbH & Co. KG is a leading global pharmaceutical service provider for clinicalCreating label layouts using BarTender® from Seagull Scientificdevelopment and commercial production of parenteral medications. The company specializes in the aseptic fillingof syringes, cartridges
and vials.hasVetterthe entire® productlife cycle
in its toprocesses,
The company
beenmanages
using BarTenderlabel design
softwarecreate itssupplying
label layouts since 2005. The®
pharmaceutical andBarTenderbio-technology
companies
throughout
global market
servicesforincludingEnterprise
Automation
editiontheincludes
powerfulwith
functionsmanagingpre-clinical
Vetter’s required label design®
development and standards
regulatoryand
approval.
the company
employs
aboutSAP
3,300people ininfrastructure.
Europe and theUSA.enterprise-levelfor easyOverall,
integration
with Vetter’s
existing
technology“ThisAnnual productionsoftwareof approximately
180usmillion
unitsprint
makes
Vetterbarcode
the global
marketleader in thepre-filled to work with, and fortool enables
to quickly
perfectlabels.
It is extremelyuser-friendly
injection system sector.
newcomers it is also easy to learn.” The software's flexibility is also very popular at Vetter: BarTender® supports all
Windows fonts and printers, with system-wide support for Unicode.

OPAL Labelmanagement for SAP®

www.opal-holding.com

GMP-compliant label printing at Vetter, a leading global provider of pharmaceutical services
Integrating labeling process with SAP®

Accurate, traceable labeling during the clinical development, manufacturing and packaging of syringes and-integrated
Labelmanagement
cartridges
is crucialquality
to patient
safety. Since
2012,
Pharmatohas
usedSAP®labeling
Vetter’s
continuousimprovement
strategy
led Vetterthe company
seek
a newsolutionthat would®
®
software,which includes
Seagull
software,from“We’dAutoIDhad
specialists
OPAL.experience withenablethe company’s
existing
SAP®Scientific'ssystem toBarTender
print BarTenderlabels.
an excellent® Top-quality, compliant labeling processes. “Our new system has realized an enormous increase in
The result:
BarTenderlabel design software, and we wanted to import our label formats from our existing stand-alone®
®
ensuresof correct
version creation
for automatedlabel printing
quality. The OPAL
and BarTender
implementationof BarTender,” saidsolution
the manager
Vetter’sGMP
IT applications
division.
Vetter also required
versionprocesses,
withaccessa transparent
auditformats
trail captured
along
the entire
chain.
We planintegration
creation,secureto the label
and directcontrolof the processing
printers, andcomplete
GMPfurther
labeling
standardin
these processes as part of our ongoing serialization projects,” said Vetter’s manager responsible for SAP® keycompliance.
user production.

Case Study
Case Study

AutoID-specialist with SAP®-expertise
After researching available labeling technologies, Vetter chose to implement the OPAL SAP®-integrated®
Vetter Pharma-Fertigung
Co. KG isexperiencea leading global
serviceSAP
providerfor clinical® labelingLabelmanagement
system. GmbH
OPAL’s&extensive
in overpharmaceutical
500 large, complex– BarTenderdevelopment
and commercial
production
systemintegrations,factored in thedecision.of parenteral medications. The company specializes in the aseptic fillingof syringes, cartridges and vials. Vetter manages the entire product life cycle in its processes, supplying
pharmaceutical and bio-technology companies throughout the global market with services including pre-clinicaldevelopment and regulatory approval. Overall, the company employs about 3,300 people in Europe and the USA.
Annual production of approximately 180 million units makes Vetter the global market leader in the pre-filled
injection system sector.

OPAL Labelmanagement for SAP®

www.opal-holding.com

GMP-compliant label printing at Vetter, a leading global provider of pharmaceutical services
Installation of a 3-system environment

Accurate, traceable labeling during the clinical development, manufacturing and packaging of syringes and®
Labelmanagement
cartridges is crucialOPAL
to patient
safety.
Since 2012,
Vetter Pharma
has used SAP
installeda three-system
environment(development,testing-integratedand production)according to Vetter’s®
software, which includes
Seagullenabling
Scientific'ssoftware,
AutoID specialists
OPAL.directly via the SAP® system —manyrequirements,
theBarTender
creation, printing
and from
administrationof the labels

The result: Top-quality,
compliantlabeling processes.
new insystem
has realized
an enormous
increaseLabelin formats, label printersparameters
are available
as standard“Ouroptions
the OPAL
Labelmanagement
software.
®
solution ensurescorrect GMP
versioncreation
automatedlabel printing
quality. The OPAL andand location
BarTender
specifications
are administereddirectly
through
theforOPAL
SAP®-integrated
system.

processes, with a transparent audit trail captured along the entire processing chain. We plan further integration inAccording to Vetter, label formats can be set up quickly, with no software development skills required. The
these processes as part of our ongoing serialization projects,” said Vetter’s manager responsible for SAP® keyLabelmanagement system is user-friendly and was easy-to-use right from the start. The Vetter team is also pleaseduser production.
with the built-in security throughout the label creation process. Every layout modification is logged by the OPAL
software, as required by GMP. Any hardware malfunction generates an immediate notification, so the system
operator can intervene right away.
“OPAL supported us not only in the system’s implementation, but also with its validation documentation, andCase Study

Case Study

troubleshooting. We’re very satisfied with the services we received, and with the training provided to ouremployees.”

Conversion and Go-Live

The complete system conversion took place over the course of six months. Label formats were configured during thisphase, facilitating a smooth transition to the new, integrated data sourcing process. Upgraded software wasinstalled. The new system went live during the second quarter of 2013.

Transparent label printing process

Vetter Pharma-Fertigung GmbH & Co. KG is a leading global pharmaceutical service provider for clinicaldevelopment and Today,
commercialof parenteral
medications.
Theshipment
companyusing
specializes
in the asepticpackaging
filling lines. Customized
Vetterproduction
packs, palletizes
and prepares
units forits state-of-the-art
of syringes, cartridges
vials.areVetter
entirelifecatalog
cycle inofitstheprocesses,
labelandlayouts
savedmanages
for everytheitem.
An productelectroniclabel classsupplying
data required for each customer andpharmaceutical andproductbio-technology
companies
the global
withprinting
servicesorincluding
pre-clinicalto be automatically
was assembled,
and throughout
enables functions
like market
conditional
other languages

development and integrated
regulatory inapproval.
company
employsabout 3,300
in Europematerial
and thenumber,USA. order and batchthe labelOverall,design theprocess.
Specificinformation,such aspeople
the customer
Annual productionnumbers,of approximately
million
Vetterorder.
the global market leader in the pre-filledwith eachis pulled 180
directly
fromunits
SAP®makes
injection system sector.

OPAL Labelmanagement for SAP®

www.opal-holding.com

GMP-compliant label printing at Vetter, a leading global provider of pharmaceutical services
Label printing using industrial printers

Accurate, traceable labeling during the clinical development, manufacturing and packaging of syringes and®
-integrated
Labelmanagement
cartridges is crucial
to patient
Pharmahas used SAPApproximately
30 industrial
labelsafety.
printersSince
from2012,
severalVetter
different
manufacturers
are usedat the Vetter
facilities.
®
®
software,which includes
Seagull
Scientific's
BarTender
software,
AutoID
OPAL. Direct control
Printing
commands
are initiatedin SAP, providing
data recording
andfrom
printingof specialists
the batch protocol.

result:canTop-quality,“Our anew
has realized
inof Thelabeling
also be setcompliant
up using labelingthe new processes.
system: “Sincenewsystemlabel doesnot haveantoenormous
be createdincreasefor every®
ensurescorrect
GMPin version
for theautomatedprintingquality.
ThecanOPAL
BarTender
print
job, wenowandload
the correctsolution
label media
in theprinteradvance,creation
and withclick of alabel
buttonselecta transparent audit trail captured along the entire processing chain. We plan further integration in
theprocesses,
right labelwith
to print.
these processes as part of our ongoing serialization projects,” said Vetter’s manager responsible for SAP® keyuser production.

Quality improvement thanks to automated data provisionAccording to Vetter, the automated management of data within the labeling process has resulted in further quality
improvements. “Populating the variable data on the label directly from the database completely eliminates theneed for manual input. This guarantees that we provide the correct data on the correct label. We now operate aprovides GMP-compliant versioning and a complete audit trail of label formats. “Now we always know by whom,
for what product and when a format was changed, and who initiated the blocking or the release. This enables us
to meet all of our obligations for documenting the labeling processes.”

Expansion through serialization
Serialization capabilities have been added, expanding the scope of the system for compliance with global
pharmaceutical traceability regulations. Each product now is marked with an individual serial number, which isregistered with the appropriate regulatory agencies, where necessary. “Another advantage of the OPAL
Vetter Pharma-Fertigung GmbH & Co. KG is a leading global pharmaceutical service provider for clinicalLabelmanagement solution is that it makes this process scalable.”development and commercial production of parenteral medications. The company specializes in the aseptic fillingof syringes,cartridges
and vials.
Vetterfrom
manages
the entire
cycle in theits processes,
supplying
Vetteris currently
consideringa changebatch-level
printedproductstock life
to printing
individual labels
on demand,
pharmaceutical
bio-technology
throughout
the global
marketservicesTheincludingwhen
the packageandis created.
“Every companies
batch is currently
preparedusing thebatchwith
protocol.
numberpre-clinicalof labels
development
approval.
company
employs
about manually.
3,300 people
in Europeand the USA.
corresponds
withand
theregulatoryorder quantity.
TheyOverall,can be theprinted
as stockand affixed
We arenow considering
Annual productionof approximately
180whenevermillion units
makes isVetterthe global
marketin thede-centralized
printing,
which means thata package
created,the printerwillleader
print out
the pre-filledlabel. The
injection
sector.
label
could systembe printed
on-site at various locations once the package has been created and it has been registered inSAP®.”OPAL Labelmanagement for SAP®

www.opal-holding.com

Case
CaseStudy
Studycomplete SAP®-integrated, automated Labelmanagement solution,” said both of Vetter’s IT experts. The system

Try It Yourself!

Americas: Sales@SeagullScientific.com+1 425 641 1408 • +1 800 758 2001

APAC: AsiaSales@SeagullScientific.com+886 2 3765 2440

Download a free, fully functional 30-day trial atwww.DownloadBarTender.com

EMEA: EMEASales@SeagullScientific+34 91 435 25 25Japan: JapanSales@SeagullScientific.com+81 3 5847 5780

© 2016 Seagull Scientific, Inc. BarTender is a registered trademark of Seagull Scientific, Inc. All other trademarks are the property of their respective owners. PRT 16-103