Success story
Almac Clinical Services LimitedIndustry• Life SciencesSolutions• OpenText™ Content Server• OpenText™ Regulated Documents• OpenText™ Remote Cache• OpenText™ Electronic Signatures

Results
Reliable, single sourceof the truth and robust
document control.
User confidence that documents
retrieved are current, helping
ensure compliance.
Reduction in time spentsearching for documentation
alone saved £350k in first year
Ability to quickly deploy new
workflows using a globally defined
standard base. Can now handle
any document type.

Almac Clinical Services’ document
health improves with OpenText
OpenText Content Server provides single source of the truth, withquick search and retrieval, improved compliance, collaboration,
rapid workflow deployment and cost savings“Locating documentation also became much quicker, saving up
to 360 hours per week or £350k per year. To help users better
understand the file plan layout, we provided them with mouse
mats, printed with the plan—simple yet effective, something
many still use today.”Paul O’Connor

Global VP Quality
Almac

Almac Clinical Services’ document health improves with OpenText

The Almac Group provides a comprehensive range of services
from research through pharmaceutical and clinical development tocommercialization of product. Headquartered in Craigavon, Northern
Ireland, where around 2,000 of their 3,600 global employees are based,
the company generates an annual turnover of half a billion dollars.
Over 600 companies worldwide, including all the market leaders, use
Almac’s services, a testament to the quality, innovation and efficiencyof the business over the past 30 years. Almac has operations in theUnited Kingdom, United States and Asia Pacific regions. Almac’s Clinical
Services business unit specializes in providing a global service for themanufacture, packaging, labeling, distribution, return and analysis ofclinical trial supplies.
Like any organization working in the global pharmaceutical industry,
Almac is heavily regulated within an ever-evolving regulatory environment.
With dozens of new laws passed each year, generating, capturing, storing
and retrieving the multitude of documents, including Standard Operating
Procedures (SOP), labelling and approvals generated on a day-to-day
basis, poses a significant on-going challenge.
Almac identified the need to move from difficult to monitor and control
paper-centric processes to more systematic and reliable processes, improving efficiency. They set out to identify a robust, scalable solution for
their growing volume of content. Moving to workflow driven processes
would also enable improvements around audit and compliance.
Andrew Hillis, group head of Information Services at Almac, expanded:“Internal collaboration was too reliant on paper documents. This
led to questions around the reliability of documents being up-todate and current which is critical in our environment. Working withexternal collaborators only compounded the problem. For example,obtaining labelling approval signatures meant numerous exchanges ofpaperwork and often involved a costly international courier. Approvals
could take up to 18 weeks.”

OpenText provides solid Content Management platform,
with opportunity for future expansion

An internal project looked in closer detail at the needs of the business:document capture, storage and retrieval, collaboration, workflow andelectronic approvals. Almac set about identifying potential solutions in
the marketplace.

Paul O’Connor, global VP, Quality at Almac, and the business sponsor,
elaborated on their ultimate selection: “Many of the solutions weevaluated offered strong document filing and storage, but OpenText
stood out from the crowd. Of particular immediate interest to us
were the capabilities OpenText Content Server provides aroundworkflow, collaboration and electronic signatures, as well as thefuture possibilities for our enterprise information needs.”
TMThe OpenText track record and understanding of heavily regulatedindustries, in particular pharmaceutical, gave Almac confidence they
had selected the solution best suited to their needs. A project team withrepresentation from the business, IT, quality assurance and OpenText
themselves began the implementation.
“One of the first areas to be moved to the OpenText solution was
documentation relating to our quality systems, a crucial aspect of ourbusiness. Change control, SOP, policy and batch record documentation
were migrated and made available to users. Following training, users
began to benefit from the carefully designed file plan, providing
improved structure and control,” added Paul O’Connor.

“OpenText provides theflexibility we need toapply the 90 percent
commonality of lifecycle
management acrossthe globe, and take into
account the 10 percent
of local nuances.”
Andrew Hillis

Group Head of Information Services
Almac

Almac Clinical Services’ document health improves with OpenText“Locating documentation also became much quicker, saving up to 360
hours per week or £350k per year. To help users better understandthe file plan layout, we provided them with mouse mats, printed withthe plan—simple yet effective, something many still use today.”Meeting the needs of a distributed user community andproviding both local and global compliance

Almac continues to grow globally, storing up to 8,000 new documents
each week, and they recently added operations in Singapore. TheOpenText solution is providing the flexibility and agility they sought aspart of their vision surrounding some 1.5 million documents to date.

“The OpenText solution has proven to be highly scalable. It fundamentally does what OpenText said it would. A lot of enterprise solutions
promise a lot but fail to deliver, Content Server does not disappoint.
For example, when we recently began operations in Singapore, wesimply made the necessary adjustments to the file plan and were up
and running. No fuss, no cost,” added Andrew Hillis.
Keeping pace with and meeting compliance requirements on a global
basis requires flexibility. While there is a high percentage of commonality
across territories, there are, however, important differences.
“OpenText provides the flexibility we need to apply the 90 percent
commonality of lifecycle management across the globe, and take
into account the 10 percent of local nuances. Using OpenText Regulated Documents we’re able to ensure compliance throughout thelifecycle,” added Andrew Hillis.
TMWith an increasingly distributed workforce of some 1,200 users, Almac
also needs to ensure optimum performance. Using OpenText™ Remote
Cache provides seamless local replication of content to any location,

maintaining security profiles. This minimizes retrieval delays, while
ensuring everyone is working consistently and reliably from the latest
document version, a critical measure for compliance and audit.
Using the highly configurable workflow capabilities of Content Server,
avoiding custom development, allied to OpenText™ Electronic Signatures,
Almac has improved efficiency and reduced costs. With over 1,100
workflows initiated weekly, and many more child processes spawned,
this is helping in areas such as labelling approvals. Significantly,approvals now typically take just two weeks, down from 18.

Passing external audit with flying colors, critical forthe businessAlmac regularly undergoes external audits and was recently inspectedby the UK medicines regulatory agency at their headquarters in Northern
Ireland. With fast retrieval from a well-defined file plan, Almac was able tosatisfy the inspectors that they are in complete control of their documentation, and passed with flying colors.

Andrew Hillis expanded, “Reputation is everything in our industry
and a poor audit can have serious detrimental effects. However, theauditors praised us, saying our provisions around documentation
were the highest quality they had come across.”
One of many key document types that come under scrutiny at audit isshipping or distribution documentation. Almac has to have the ability to
trace any single shipment through batch numbers, dates and a variety ofother data points. With distribution a 24-hour-a-day, seven-days-a-week,
operation, they put their trust in OpenText, storing each and every pieceof documentation which may need to be retrieved at a moment’s notice.

“Reputation is everythingin our industry and a poor
audit can have serious
detrimental effects.
However, the auditors
praised us, saying ourprovisions arounddocumentation were thehighest quality they had
come across.”Andrew Hillis

Group Head of Information Services
Almac

Almac Clinical Services’ document health improves with OpenText

Future plans to expand on the solid OpenText platform

Since implementing OpenText™ Content Suite Platform, Almac has benefitted in many ways. But OpenText continues to innovate and so they are
now planning to update to the latest Content Suite Platform, including
OpenText™ Records Management,, greater provision for mobile device
use, and greater collaboration, especially with customers.

“The relationship with OpenText has without doubt been mutuallybeneficial. It doesn’t follow the usual purchase order driven motivations
we see all too often. OpenText go out of their way to keep us informedof their roadmap developments, and the account management teamact as an advocate for us. It’s all about doing the right thing for thecustomer,” concluded Andrew Hillis.

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 aboutOpenText (NASDAQ: OTEX, TSX: OTEX)
visit opentext.com.
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