About The Company
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.
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 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 time frame.
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 time frame 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.”
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 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
“It was a stressful but very productive three months. It’s very impressive what can be accomplished with motivation, expertise and cooperation,” notes Beninati.
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 allin-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 pallet
- 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.
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