Case Study

Pharmaceutical company Krka streamlines

compliance and label management
Unifying labeling with the NiceLabel Enterprise Platform improves master data management,
streamlines compliance and builds a next-generation system to support future growth.

Industry: Pharmaceutical
Solution: NiceLabel Enterprise Platform
Background
Krka is one of the top generic pharmaceutical companies in Europe. The
Challenges
company produces and sells prescription pharmaceuticals, non-prescription
›› Complex regulatory compliance
›› Various technologies and fragmented label products and animal health products. With headquarters in central Europe,
creation production sites in five countries and multiple distribution centers, Krka
›› Complex master data management
delivers medications to more than 70 countries worldwide.
›› Too many label variations
›› Long cycle times for changes
Krka was in the process of building a new state-of-the-art production facility.
Solutions
The team at Krka knew that their existing labeling processes would not
›› Electronic label lifecycle management system
›› A single, unified platform to design, integrate support future growth. The construction of the new facility presented an
and manage labeling opportunity to modernize legacy systems and implement new technologies,
›› Electronic and centralized label catalog which would be used in other facilities if proven successful.
›› Graphical label design interface for business
users
›› Real-time integration with SAP and Werum Krka reached out to a long-term partner Spica International and the NiceLabel
›› Label preview within SAP team with the goal to unify labeling to a single platform, have better over-
sight of label variations and streamline regulatory compliance processes.
Results
›› Increased efficiency and streamlined compliance
›› Label consistency and customer responsiveness
›› Label template consolidation “ We had outgrown our existing system and wanted to put a next-
›› Business ownership and governance for label generation solution in place to achieve sustainable long-term growth.
content and layouts
ANTON SKOF, IT DEPARTMENT MANAGER, KRK A
”
›› Label system consolidation and scalability

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 “ Failing an audit would have a devastating
Challenges effect on the company’s revenue.
”
ANTON SKOF, IT DEPARTMENT MANAGER, KRK A

Complex regulatory compliance Complex master data management

One of Krka’s challenges was adhering to the stringent reg- In heavily regulated markets like the pharmaceutical industry,
ulations in each of their key markets. Failing an inspection the label is an essential master data record. Master data man-
in a specific country could jeopardize sales in that country agement is a very complex and mission-critical component
and consequentially in others. Among other things, the of the business. Krka had high standards for its master data
regulations require documenting every change in the system and wanted to bring label data to the same quality level as its
including new and updated label templates. All printed labels other master data. In order to do this they needed to find a
also need to be archived for a year after the end of the prod- way to integrate label lifecycle management with their master
uct lifetime. Krka has strict internal governance procedures data management system.
that ensure compliance. However, these paper-based proce-
dures were labor intensive and required a lot of documenta- Too many label variations
tion. Krka needed to establish an electronic label compliance Krka had a label catalog which was used to maintain over-
process that would improve quality assurance while reducing sight to all of the company’s labels. The catalog was frag-
manual operations. mented and management of label template revisions across
Krka’s various systems was extremely complex and consumed
Various technologies and fragmented label creation valuable IT resources and time. Krka needed to reduce the
Krka has multiple systems that touch the labeling process number of label templates to a more manageable number and
including SAP and Werum, its MES platform. They uploaded to use a single centralized platform for label design, change
barcode printer programming language (coded templates) control, printing, integration and management.
into SAP and also at local production sites on the Werum
system. Results varied between each system, so labeling
lacked consistency. To address this, Krka’s labeling staff had
to create label formats to accommodate each system. While
this helped to address label inconsistencies, Krka ended up
with hundreds of hard coded label templates and long cycle
times for label creation and change requests. They also relied
heavily on their IT department. Recreating labels for dispa-
rate systems cost Krka valuable man hours and negatively
impacted customer response times. Krka needed to consoli-
date its label printing process and systems.

WWW.NICEL ABEL .COM / EN T ERPRISE

 “ With NiceLabel, we made a significant im-
provement in the quality and management
Solutions of the label catalog. We continue to reduce
the number of label templates as we roll out
changes to our other systems.
ANTON SKOF, IT DEPARTMENT MANAGER, KRK A
”

Electronic label lifecycle management system Electronic and centralized label catalog
NiceLabel enables Krka to streamline compliance with Krka has the ability to quickly search through all label data
FDA and GMP requirements. The electronic label design across the enterprise. Instead of designing a new template and
and approval processes ensure data accuracy, reduce pa- increasing complexity, the team at Krka can quickly find and
perwork and increase customer responsiveness. Krka uses compare existing label variations and avoid template duplica-
an HTML5 based Web application to preview and inspect tions. Users now have the ability to compare and graphically
label content against specifications. Built-in approval and highlight the differences between labels on their screen. Even
validation rules and role-based access prevent users from the smallest variations are clearly visible. This helps Krka
completing more than one step at a time in the validation achieve a previously unavailable level of quality control, label
process, which ensures compliance. Copies of all printed data accuracy and template consolidation.
labels are automatically archived in a PDF format instead of
printed documentation, which significantly reduces paper- Graphical label design interface for business users
work and lowers archiving costs. Labels are now designed by business users who best under-
stand the requirements. They no longer depend on IT to
A single, unified platform to design, integrate and program printer specific code and can quickly design accurate
manage labeling labels that meet customer and regulatory requirements.
With NiceLabel, Krka now uses a single platform to man-
age all aspects of labeling. The same universal template is Real-time integration with SAP and Werum
used for label printing regardless of the printer model or With NiceLabel’s high speed 64-bit automation labeling ser-
system that initiates the task (Werum for manufacturing vice bus, Krka is able to integrate with SAP and Werum using
execution and SAP for other business operations). pre-built certified connectors, without custom programming.
The real-time label preview inside the SAP form streamlines
the validation in the change management process, offers
GS1-A 4.lbl GS1-A 4-oem.lbl Comparison
another quality check for the operator before printing and
simplifies regulatory agency audits. Additionally, the seamless
integration has another benefit – the operator user-interface
remained the same so no additional training was needed for
print operators.

FIGURE 1:
L ABEL COMPARISON EX AMPLE. CONTROL CENTER ENTERPRISE

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 “ Regardless of the system being used
or the location, the right label template
Results is printed and the output is consistent
across all systems.
”
ANTON SKOF, IT DEPARTMENT MANAGER, KRK A

Streamlined compliance Business ownership and governance for label content

The electronic label lifecycle management system that and layouts
replaced the paper-based compliance system is saving Krka Business users at Krka can now design and manage labels
countless man hours, which translates into significant cost without the help of IT. This dramatically improves cycle times
reduction. With the new system in place Krka’s agencies and and reduces the overall time spent on labeling.
customers can rest assured that Krka is following best-in-
class practices for quality. Label system consolidation and scalability
All systems are now integrated on the same centralized plat-
Label Consistency and customer responsiveness form. This means less knowledge management costs, seam-
The consolidation of label systems and processes has result- less connectivity, consistency and dramatically simplified
ed in better customer response times and eliminated label change management. The simplified, integrated and unified
inconsistencies. Regardless of the system being used, or the labeling system can be scaled and extended to stimulate in-
location, the right label template is printed and the output is stead of limit future growth.
consistent across all systems.
Future outlook
Label template consolidation —The ability to search the Krka plans to extend their unified labeling system to sup-
label catalogue and compare the differences between similar pliers and sub-contractors so that they can use the label
templates has helped Krka eliminate duplicate labels and template that is used internally. This will help them optimize
also reduce the number of label templates that they need to inbound logistics and most importantly to improve master
maintain. data management.

To learn more about NiceLabel’s solutions for the pharmaceutical industry, visit www.nicelabel.com/pharma

About the NiceLabel Enterprise Platform

The NiceLabel Enterprise Platform is the only 64-bit true-next-generation modular solution
www.nicelabel.com/enterprise designed to address the complex labeling requirements of large and highly regulated organiza-
tions. The NiceLabel Platform and its unique “configure, don’t code” approach delivers a new
level of “print productivity”. NiceLabel’s core technology is proven with hundreds of thousands
of customers, making it the most robust enterprise labeling solution.

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