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AESICA PHARMACEUTICALS
It’s critical in our business to
be able to adapt to unforeseen
changes. QAD helped us do that.
Maurizio Beninati, IT Director, Aesica Pharmaceuticals
CUSTOMER CASE STUDY
AESICA PHARMACEUTICALS | CUSTOMER CASE STUDY©QAD INC.
AESICA PHARMACEUTICALS CASE STUDY
AESICA UPGRADES THEIR
QAD ERP SOLUTION WHILE
MEETING AN ACCELERATED
SERIALIZATION DEADLINE
THE COMPANY: AESICA PHARMACEUTICALS
Aesica Pharmaceuticals s.r.l. is the Italian division
of Aesica Ltd (UK), one of the world’s leading
pharmaceutical contract development and
manufacturing organizations. The company is
committed to being fast, flexible, innovative and
reliable with a dedication to service and working
in partnership with their customers to achieve
outstanding results. In state-of-the-art facilities
Aesica is constantly evolving their technical
and analytical skills to meet the ever-changing
development and manufacturing demands of their
customers in a growing number of markets.
Prior to being acquired by Aesica UK, Aesica
Pharmaceuticals was part of UCB, a global
biopharma company. Their high performance levels
were a major factor in the acquisition.
While with UCB, Aesica Pharmaceuticals used
QAD Enterprise Applications, and with their proven
success record Aesica UK chose to keep QAD as
the ERP solution for Aesica Pharmaceuticals, even
though SAP is used elsewhere in the company.
THE CHALLENGE: A CRITICAL DEADLINE
CHANGE REQUIRES A VERY FAST RESPONSE
Major changes in product serialization and tracking
regulations are happening in pharmaceutical markets
worldwide. The main goal of the new requirements
is to maintain customer safety while fighting drug
counterfeiting, streamlining the recall process and
minimizing financial loss.
A large percentage of the production of Aesica’s
pharmaceutical products is for the Chinese market.
Worldwide deadlines for adhering to the new
serialization regulations vary by country, ranging
from 2014 to 2017, and the China Food and Drug
Administration (CFDA)1
deadline was 12 months out.
The work needed for conforming to the new China
regulations was underway with plans to implement
within the twelve-month timeframe.
Aesica Pharmaceuticals was faced with an
unexpected challenge when the Chinese government
moved up the deadline for meeting all products
serialization requirements; suddenly a twelve-month
timeframe was condensed to a three-month deadline.
“This deadline change was a huge challenge for
Aesica Pharmaceuticals,” notes Maurizio Beninati, IT
Director at Aesica Pharmaceuticals. “The process of
meeting the serialization regulation deadlines had to
be expedited immediately. If we didn’t meet this new
deadline we would be fined substantially, and it could
damage future dealings with our Chinese customers.”
THE SOLUTION: A QUICK RESPONSE MADE
POSSIBLE BY A COLLABORATIVE EFFORT
QAD quickly responded by collaborating with Aesica
Pharmaceuticals’ management to present alternative
courses of action. A new Serialization module was
in development in QAD Enterprise Applications
HIGHLIGHTS
Company Aesica Pharmaceuticals
Limited
Location Pianezza, Italy
Industry Pharmaceutical
Manufacturing
Products Contract development
and manufacturing
(wet granulation,
tablet production,
encapsulation, liquid
manufacturing, blister
packaging, bottle
packing)
Solutions Utilized QAD Enterprise
Applications
Enterprise Edition
AESICA PHARMACEUTICALS | CUSTOMER CASE STUDY©QAD INC.
Enterprise Edition (QAD EE) which addressed the new
regulations. An upgrade to QAD EE and using the new
Serialization module was the answer.
Working hard and fast, QAD and Aesica
Pharmaceuticals collaborated and had a
presentation ready in only three weeks to obtain
corporate approval.
Very soon after, the QAD EE upgrade was in motion
with QAD’s research and development team working
directly with Aesica Pharmaceuticals’ information
technology group on the new Serialization module.
Aesica Pharmaceuticals was compliant with the new
serialization requirements three months after the
initial request.
“It was a stressful but very productive three months.
It’s very impressive what can be accomplished
with motivation, expertise and cooperation,” notes
Beninati.
THE BENEFITS: NEW DEADLINE IS MET AND
CHINESE REVENUE STREAM IS PROTECTED
With QAD’s assistance, Aesica Pharmaceuticals met
the accelerated deadline. The relationship with their
Chinese pharmaceutical market customers continues
to be solid and ready for future growth.
The decision to keep and upgrade QAD as the ERP
system in Italy proved to be the right choice. The
Serialization module will be used in all of Aesica
Pharmaceuticals’ other markets as the varying
deadlines approach.
Aesica Pharmaceuticals has also found a complete
all-in-one solution for their financial needs and
procedures with the new Enterprise Financials
module.They have reduced the number of
applications they are using down to the essentials,
achieving their goal of covering all their business
processes in one complete ERP solution.
Aesica Pharmaceuticals can now:
• Identify each individual packaging unit down to the
smallest sellable unit
• Aggregate individual unit serial numbers as
packages are bundled, boxed and placed on
shipping pallets
• Seamlessly track and trace each single pack of
medication
• Report serial numbers to the required government
agencies once products have been produced and
imported
Aesica Pharmaceuticals benefited not only by
meeting the accelerated serialization regulation
deadline while upgrading to QAD EE, they also were
able to show an example to Aesica UK of their ability
to successfully handle unexpected change.
1
Prior to April 2014 the CFDA was the Chinese State Food and
Drug Administration (SFDA)
QAD has been a great partner
in the rush to meet the unexpectedly
accelerated deadline from China. We
couldn’t have conquered this challenge
without their help and expertise.”
Maurizio Beninati, IT Director, Aesica Pharmaceuticals
AESICA PHARMACEUTICALS CASE STUDY
©QAD INC.
www.qad.com

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Aesica-QAD-Italy

  • 1. AESICA PHARMACEUTICALS It’s critical in our business to be able to adapt to unforeseen changes. QAD helped us do that. Maurizio Beninati, IT Director, Aesica Pharmaceuticals CUSTOMER CASE STUDY
  • 2. AESICA PHARMACEUTICALS | CUSTOMER CASE STUDY©QAD INC. AESICA PHARMACEUTICALS CASE STUDY AESICA UPGRADES THEIR QAD ERP SOLUTION WHILE MEETING AN ACCELERATED SERIALIZATION DEADLINE THE COMPANY: AESICA PHARMACEUTICALS Aesica Pharmaceuticals s.r.l. is the Italian division of Aesica Ltd (UK), one of the world’s leading pharmaceutical contract development and manufacturing organizations. The company is committed to being fast, flexible, innovative and reliable with a dedication to service and working in partnership with their customers to achieve outstanding results. In state-of-the-art facilities Aesica is constantly evolving their technical and analytical skills to meet the ever-changing development and manufacturing demands of their customers in a growing number of markets. Prior to being acquired by Aesica UK, Aesica Pharmaceuticals was part of UCB, a global biopharma company. Their high performance levels were a major factor in the acquisition. While with UCB, Aesica Pharmaceuticals used QAD Enterprise Applications, and with their proven success record Aesica UK chose to keep QAD as the ERP solution for Aesica Pharmaceuticals, even though SAP is used elsewhere in the company. THE CHALLENGE: A CRITICAL DEADLINE CHANGE REQUIRES A VERY FAST RESPONSE Major changes in product serialization and tracking regulations are happening in pharmaceutical markets worldwide. The main goal of the new requirements is to maintain customer safety while fighting drug counterfeiting, streamlining the recall process and minimizing financial loss. A large percentage of the production of Aesica’s pharmaceutical products is for the Chinese market. Worldwide deadlines for adhering to the new serialization regulations vary by country, ranging from 2014 to 2017, and the China Food and Drug Administration (CFDA)1 deadline was 12 months out. The work needed for conforming to the new China regulations was underway with plans to implement within the twelve-month timeframe. Aesica Pharmaceuticals was faced with an unexpected challenge when the Chinese government moved up the deadline for meeting all products serialization requirements; suddenly a twelve-month timeframe was condensed to a three-month deadline. “This deadline change was a huge challenge for Aesica Pharmaceuticals,” notes Maurizio Beninati, IT Director at Aesica Pharmaceuticals. “The process of meeting the serialization regulation deadlines had to be expedited immediately. If we didn’t meet this new deadline we would be fined substantially, and it could damage future dealings with our Chinese customers.” THE SOLUTION: A QUICK RESPONSE MADE POSSIBLE BY A COLLABORATIVE EFFORT QAD quickly responded by collaborating with Aesica Pharmaceuticals’ management to present alternative courses of action. A new Serialization module was in development in QAD Enterprise Applications HIGHLIGHTS Company Aesica Pharmaceuticals Limited Location Pianezza, Italy Industry Pharmaceutical Manufacturing Products Contract development and manufacturing (wet granulation, tablet production, encapsulation, liquid manufacturing, blister packaging, bottle packing) Solutions Utilized QAD Enterprise Applications Enterprise Edition
  • 3. AESICA PHARMACEUTICALS | CUSTOMER CASE STUDY©QAD INC. Enterprise Edition (QAD EE) which addressed the new regulations. An upgrade to QAD EE and using the new Serialization module was the answer. Working hard and fast, QAD and Aesica Pharmaceuticals collaborated and had a presentation ready in only three weeks to obtain corporate approval. Very soon after, the QAD EE upgrade was in motion with QAD’s research and development team working directly with Aesica Pharmaceuticals’ information technology group on the new Serialization module. Aesica Pharmaceuticals was compliant with the new serialization requirements three months after the initial request. “It was a stressful but very productive three months. It’s very impressive what can be accomplished with motivation, expertise and cooperation,” notes Beninati. THE BENEFITS: NEW DEADLINE IS MET AND CHINESE REVENUE STREAM IS PROTECTED With QAD’s assistance, Aesica Pharmaceuticals met the accelerated deadline. The relationship with their Chinese pharmaceutical market customers continues to be solid and ready for future growth. The decision to keep and upgrade QAD as the ERP system in Italy proved to be the right choice. The Serialization module will be used in all of Aesica Pharmaceuticals’ other markets as the varying deadlines approach. Aesica Pharmaceuticals has also found a complete all-in-one solution for their financial needs and procedures with the new Enterprise Financials module.They have reduced the number of applications they are using down to the essentials, achieving their goal of covering all their business processes in one complete ERP solution. Aesica Pharmaceuticals can now: • Identify each individual packaging unit down to the smallest sellable unit • Aggregate individual unit serial numbers as packages are bundled, boxed and placed on shipping pallets • Seamlessly track and trace each single pack of medication • Report serial numbers to the required government agencies once products have been produced and imported Aesica Pharmaceuticals benefited not only by meeting the accelerated serialization regulation deadline while upgrading to QAD EE, they also were able to show an example to Aesica UK of their ability to successfully handle unexpected change. 1 Prior to April 2014 the CFDA was the Chinese State Food and Drug Administration (SFDA) QAD has been a great partner in the rush to meet the unexpectedly accelerated deadline from China. We couldn’t have conquered this challenge without their help and expertise.” Maurizio Beninati, IT Director, Aesica Pharmaceuticals AESICA PHARMACEUTICALS CASE STUDY