BarTender® Software Case Study

Automated pharmaceutical label production increases
accuracy and compliance while reducing risk
The labeling systems deployed by pharmaceutical manufacturers must include a rigorous set of controls
to protect the integrity of the pharmaceutical supply chain. A major pharmaceutical company deployed
ROBAR, an integrated label management system that features BarTender® labeling software, to transform
its labeling processes. The company experienced streamlined workflows, reduced potential for error,
and improved regulatory compliance capabilities.
“We evaluated several competing
solutions, and found BarTender tobe the best choice because of its
advanced programming interface,solid reliability, exceptional
support and unmatched flexibility
for label design and printing.
Integrating BarTender into
Innovatum’s ROBAR systemenables the world’s best label
software to be used in compliancewith all US and internationallabeling regulations.”
Ardi Batmanghelidj
President, Innovatum,maker of ROBAR

The challenge:
Secure, compliant
pharmaceutical labeling
Pharmaceutical manufacturing isamong the most highly regulated
global industries, and justifiably so.
With its complex, multi-nodal supply
chain, the integrity of that supply
chain—and in turn, patient safety—
can be at risk at each link.
In the US, for example, Part 11 of
the Code of Federal Regulations(CFR) 21 stipulates a company must
capture and record activity of any
electronic system used to identify
and track pharmaceutical products
throughout the supply chain.
And drug serialization, e-pedigree
and other traceability requirements
soon to take effect in Europe, theUS, China and Brazil mean that
almost 2,500 million consumers
worldwide will be protectedby new, stringent standards.
These efforts are driven by concernfor drug quality and patient safety.
They aim to protect the global
drug supply from adulteration
occurring via manufacturer error,
counterfeiting or acts of terror.
Violation of these regulations, which
are enforced by periodic, detailed
audits of pharmaceutical processes
and facilities, may subject a company
to penalties, fines and worse: apharmaceutical company lacking inproper controls potentially exposes
its customers to the risk of illness ordeath. And the commercial costs ofan adverse event, including the lossof sales, reputation and market value,
can devastate a business.

By shoring up the supply chain
and employing rigorous processes
that increase levels of control,
pharmaceutical companies canenable regulatory compliance acrossthe enterprise, protect the products
they manufacture and distribute—and generate cost savings throughincreased efficiencies.

Transforming thelabeling process ata pharmaceutical facility
Recognizing that their label
generation process was inefficientand creating opportunities for error,a multinational pharmaceuticalmanufacturer sought to streamline
its operations by deploying a fully
automated labeling system.
The company administered,shared and printed over 5,000
individual label files using a highly
manual process.

To print a product label, line
operators browsed through server
files and folders, accessing thecorrect label format by file name.
The operator opened the label
design file in maintenance mode,and then manually entered values
for manufacturing data such as
lot and production numbers andexpiration date directly on the label
template, creating a new file for every
label generated. The label was thenprinted and saved to a file folder on
the local server.
The process was similar for printinglabels at the company’s remoteplants. Administrators at the main
facility navigated to the correct label
format on their central server, andsent it to the remote plant as anemail attachment. There, the dataon the label was edited by the user
to reflect the appropriate production
variables, printed, and saved on thatfacility’s server.

The system relied substantiallyon individual user expertise andaccuracy, and its lack of controls
presented multiple windows for error.
It depended on the latest version ofa label file being stored in its proper
place in the production folder, and on
the labeling operator remembering
its correct location. Auditability
was compromised by sharing files
via email, with label files stored on
local servers rather than in a central
repository. There was no protocol
to ensure proper file backups wereperformed.
And the system wasn’t scalable
to future needs. With each newlabel, the number of individual
files increased, and the manual
nature of the label administration
processes precluded compliancewith anticipated global e-pedigreeand serialization requirements.

The solution:
ROBAR and BarTender
After evaluating available options, thepharmaceutical manufacturer choseto deploy the ROBAR enterpriselabel management system from
Innovatum, Inc. ROBAR includes
BarTender label software from
Seagull Scientific as an integrated
component of its system, providing
the label template, barcoding anddesign interfaces and unparalleledprinter support via a browser based
printing solution.
Now, through the automation
capabilities provided by thisintegrated management system,
the entire labeling process ismanaged without the user evertouching an individual label file.
All label templates and content are

maintained in a secure, versioncontrolled database. Variable datasuch as lot number, expiration dateand serial number are shared fromexternal, validated ERP, PLM andserialization systems at print time.

comply with global regulations. The
system now provides complete audit
trail capability and 21 CFR Part 11
electronic signature compliance.

ROBAR allows the pharmaceuticalcompany to be agile in the face ofchanging business needs—centralThe operator initiates the label
file management means that label
printing process through a browserbased print screen, submitting a work changes are now implemented acrossorder. The system then automatically, the enterprise in a matter of seconds,
applied to all relevant records andaccurately and reliably merges thelabel templates. The new, streamlined
variable data with the appropriate,approved version of the label template, and efficient processes are realizing
cost savings for the company, andprints the label, and captures a
the built-in regulatory compliancecomprehensive audit trail.
structures are reducing corporate risk.
Instead of personnel hours spent
The new labeling processes areindividually managing 5,000 label
scalable across the enterprise, andfiles and their content manually, theadaptable to meet the gamut ofcompany now centrally administers
serialization, e-pedigree, and otherjust 60 label templates, which aretraceability requirements as they areautomatically populated with aimplemented.
secure, auditable, central database oflabel content.
To learn how BarTender and ROBAR
can help your pharmaceutical or
ROBAR’s web-based design
medical device company meetenables granular security accesscompliance initiatives while
and incorporates layered security
streamlining your supply chain, visit
features, including role-based
seagullscientific.com, or contact
permissions. Automated, multi-user,
us by phone.
browser-based review and approval
workflows provide system controls.
And BarTender provides ROBAR
with incrementing serialization
capabilities with the flexibility toserialize per-page, per-job, or by data
source or database field change, withadditional support for host-driven,randomized serialization.

Benefits
By placing controls on workflows,data entry and printing, BarTenderand ROBAR have reduced thepotential for user error in labelingprocesses, while securing andimproving the company’s ability to+1-770-945-4595

Synopsis A major pharmaceuticalcompany used a manual,
operator-managed system
to administer over 5,000
individual label files, eachstored and accessed byfile name.
 Data changes were entered by
the user directly into the label
format, and then shared acrossthe enterprise via email.
 The system was unauditable,
and out of compliance with
21 CFR Part 11—its lack ofautomation increased potential
for user error.
 The company selected theROBAR enterprise label
management system, whichuses BarTender for label design
and printing.
 Now, label formats are storedcentrally via a browser-based
print screen—the user neveropens or changes a label file.
 The multi-user, enterprise-wide
workflow system provides
review and approval of label
designs and data.
 Variable manufacturing data
are pulled from validated
interfaced systems, mergedwith an approved BarTender
template, and then the label isprinted.
 The company is protected
through reduced error potential,
full audit trail capabilities, andcompliance with electronic
signature requirements.
 The system is fully scalable
to meet the serialization andtraceability provisions of DQSA
and other global regulations
as they come into force.

Americas: Sales@SeagullScientific.com • +1 425 641 1408
EMEA: EMEASales@SeagullScientific.com • +34 91 435 25 25
APAC: AsiaSales@SeagullScientific.com • +886 2 3765 2440
Japan: JapanSales@SeagullScientific.com • +81 3 5847 5780

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