Success story
Pharma International Co.
Industry• PharmaceuticalSolutions• OpenText™ Content Suite Platform• OpenText™ Brava!™
• OpenText™ Extended Workflow(including OpenText™ Electronic Signatures)

Results
Workflow-driven processes
speeds up regulatory submissions
with greater accuracy and reliability
Packaging document and image
version comparison capabilities
greatly reduce time spent
managing changes
43% improvement in overall
efficiency of business processes

Pharma International improves
the health of their content-centricbusiness processes

Process automation, easy version comparison and a single,
central content repository drive efficiency and ease compliance burden“Being able to cover everything from scanning, document
creation, workflow, records management, document andimage comparisons, electronic signatures and out-of-the-box
integration to other enterprise systems meant that OpenText
was the only choice for us.”
Ahmad Alshami

IT Manager
Pharma InternationalPharma International improves the health of their content-centric business processes

Pharma International Co. (PIC) offers a range of pharmaceuticalproducts and services focused on generics, starting from theearliest stage of research & development and including large—
scale commercial manufacturing operations, quality testing,
distribution and marketing in the Middle East and North Africa(MENA) region and Europe.
Their pharmaceutical portfolio covers a variety of production lines ofvarious usage forms: tablets, capsules, injections, syrups, dry suspensions, suppositories, medicated shampoos, creams, ointments andgels. The diverse portfolio covers most therapeutic classes, withextensive specialization in cephalosporin antibiotics. PIC is one of only asmall number of companies with dedicated cephalosporin manufacturing
capabilities in the region. PIC launched their first product in 2001 andnow reaches more than 20 countries.
The pharmaceutical industry is renowned for being heavily regulated.
Consequently, pharmaceutical companies rely heavily on a substantial
volume of documentation to track and manage every aspect of research,
manufacturing, testing, distribution, packaging, labelling and quality
assurance. PIC meets the stringent requirements of the Food and Drug
Administration (FDA) and World Health Organization (WHO) and their
Good Manufacturing Practices (GMP). In order to do so, they needed toaddress shortfalls in their existing document and other content management provisions, especially that of product packaging and labelling.

Reduce time spent on regulatory returns and enableversion comparison

Among the challenges that PIC faced was the length of time it took themto collate information for regulatory submissions. The old system lacked
the ability to provide quick, easy-to-view document comparisons, which

are required to track changes coming from multiple sources. There wasalso no way of performing systematic comparisons of image files, suchas drawings, for product packaging and labelling.
Consequently, human errors became commonplace and manualcomparisons became time consuming.
“When replacing the existing system, we engaged all areas of thebusiness to ensure we captured comprehensive requirements. Bydoing this, we were able to set a vision for the future, and we began tolook for a solution that would meet our needs today and long into thefuture,” explained Ahmad Alshami, IT manager at Pharma International.
With a clear vision and requirements documented, PIC set about looking
for a solution. They considered a number of possibilities, but only one
offered the diversity and breadth of capability that is needed to meettheir long-term goals: OpenText™ Content Suite.
“We were impressed that OpenText has the ability to provide themost complete, end-to-end Enterprise Information Managementsolution. Being able to cover everything from scanning, document
creation, workflow, records management, document and image
comparisons, electronic signatures and out-of-the-box integration
to other enterprise systems meant that OpenText was the only choicefor us,” added Alshami.

An efficient and effective implementation

Continuing on the theme of inclusivity, PIC involved representatives
from across the business in the implementation project. This ensured
that their needs would be taken into account. Representatives frommarketing, artwork, administration, production, quality assurance, IT,finance and legal worked with the established local OpenText partner
Mediterranean Sea & Gulf for Computer Services (MGS).

“Using OpenText Brava!
helps us compare thetext and layout for two
different pieces ofartwork, even if it isjust a single letteror number.”
Khalid Elyan

Planning Manager
Pharma International

Pharma International improves the health of their content-centric business processes“Having a project team comprised of representatives from acrossthe business with backup and support from OpenText and MGS had
a positive impact on our implementation. The combination worked
well and provided the knowledge and flexibility we needed to deliver
the solution into production,” said Alshami.
The majority of the functionality that PIC sought is provided by theOpenText Content Suite Platform out-of-the-box. However, PIC had
specific needs around their business processes, such as automatic
batch number generation and integration of their own HTML forms, thatwere easily addressed using the Content Suite developer tools.
TMReduce risk of non-compliance and speed time to market

OpenText helps PIC resolve a number of significant challenges, including
performing visual comparisons of packaging design and labelling. Thesolution provides dynamic document workflows that offer parallel, rather
than sequential approval steps.

“Using the intuitive and flexible graphical workflow design tools, weare able to quickly set up our complex packaging design, review,
and approval processes. A key part of this process is the ability tocompare changes made between two versions of a document ordrawing using OpenText™ Brava!™ This saves us time and reduces
errors,” noted Alshami.
In the area of product labelling and packaging, PIC interacts withnumerous external parties, and develop various versions for different
markets. Brava! helps PIC streamline the process of managing review
and approval cycles, while the workflow capabilities of Content Suite
automate process steps, notifications, alerts and provide reporting.

“Using OpenText Brava! helps us compare the text and layout for two
different pieces of artwork, even if it is just a single letter or number,”added Khalid Elyan, planning manager, Pharma International.

Approval of packaging involves numerous external parties, which canvary by region. Using OpenText™ Extended Workflow, PIC can track andmanage these interactions maintaining an audit trail of correspondence,drawing versions, and the final approvals using electronic signatures.
This helps PIC meet their compliance obligations and ensures they canproduce the necessary submissions to regulators.

“One of our key performance indicators (KPIs) is the average
process time of a workflow. We see an improvement time of 43%
when comparing present-day times with the old system. In addition,
tracking and follow-up of tasks are improved due to multiple waysof tracking processes either by establishing a custom report, visual
workflow process mapping, or dynamic search in workflow names,”
noted Elyan.

Once documentation and drawings are approved, they are stored inContent Suite. This provides a single source for all content, rather
than the previously disparate storage silos. When a regulation changes
in a particular market, users can now quickly access the entire packageof content relating to any product, see the history and initiate anynecessary actions.

Building on benefits and planning for the future

PIC set out a vision for the future of their enterprise information. WithContent Suite they are well on the way to realizing that vision. Process
efficiencies and automation, ease of tracking approvals and fast, accuratecomparison of content versions all contribute to a better information
management culture at the organization.

Plans are in place to extend the use of OpenText software into otherareas and processes across the business. The next phases will consider
records management, integration with other systems such as Enterprise
Resource Planning (ERP) and the use of mobile devices.

“One of our key
performance indicators
is the average process
time of a workflow. We
see an improvement timeof 43% when comparing
present day times withthe old system.”
Khalid Elyan

Planning Manager
Pharma International

Pharma International improves the health of their content-centric business processes“With OpenText, we have established a solid, reliable, and effective
base from which to build,” concluded Alshami.

About MGS

Mediterranean Sea & Gulf for Computer Services (MGS) is a dynamically growing company and leader in providing specialized enterprisebusiness and IT solutions and services. MGS focuses on ECM solutions
for unstructured data and ERP for structured data. With over 15 years ofexperience in OpenText and SAP® product and solutions, MGS has built
a solid implementation methodology in order to ensure success andquality services for ECM for SAP. The range of services we offer, fromclassic consulting services to implementation and operational support,
provide great benefit to our clients because of our team’s deep projectexperience. In the end, we have one objective: a cost-effective, profitable utilization of ECM technologies focusing on meeting your businessobjectives, not technology for technology’s sake.
mgs-tech.com

MGS

About OpenText

OpenText, The Information Company,
enables organizations to gain insight
through market leading information
management solutions, on-premises orin the cloud. For more information about
OpenText (NASDAQ: OTEX, TSX: OTEX)
visit opentext.com.
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