AESICA PHARMACEUTICALS

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 time frame.

Aesica Pharmaceuticals was faced with an unexpected challenge when the Chinese government moved forward the deadline for meeting all products serialization requirements; suddenly a twelve-month time frame was condensed to three-months.

“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 Enterprise Edition (QAD EE) which addressed the new regulations. A QAD ERP  upgrade and using the new Serialization module was the answer. Working hard and fast, QAD and Aesica Pharmaceuticals collaborated and had a presentation ready in just three weeks to obtain corporate approval.

Very soon after, the QAD ERP 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 QAD ERP, they also were able to show an example to Aesica UK of their ability to successfully handle unexpected change.