"TrackWise Digital has resulted in single QMS for our company. In doing so, we and other pharmaceutical companies that implement an integrated system can expect to see cost savings in the introduction of TrackWise Digital, annual upgrades, users account fees and technical services. Unifying the system enables total quality management. We can now readily access quality data, so it will be possible to unify that as well. The data can be used and deployed globally. We are confident that this will ultimately benefit patients”

Ryuichi Yamasaki,
Senior Director of Data Integrity, Eisai

Ask anyone at Eisai what they do, and you may be surprised to not hear mention of the word “pharmaceutical.” This is because while Eisai may be categorized as a pharmaceutical company, the company considers itself to be a human health care (HCC) provider and has based its corporate philosophy on HHC. 

In its traditional sense, Eisai develops, manufactures, and distributes prescription pharmaceuticals, primarily in North America and Japan. Prescription drug sales account for a majority of the company’s revenues and are led by Aricept, which treats Alzheimer’s disease. Other drugs include Pariet (known as AcipHex in the US), an acid reflux and ulcer treatment. Development programs target neurology, oncology, vascular, and immunological ailments. In addition, in Japan Eisai distributes over-the-counter drugs and consumer health products. The company also makes chemical active pharmaceutical ingredients (APIs). 

At its heart, Eisai’s mission is to consider the emotions of patients and consumers, ensure a high-level of patient satisfaction and meet various healthcare needs around the world. Its corporate philosophy is implemented in all daily activities by each employee.

THE OPPORTUNITY

Moving from On-Premises to the Cloud 
Eisai has been a TrackWise customer since 2006, starting with its US location. Since that time Eisai has implemented solutions in the EU, India, China and Japan. A key criterion for the company was to create standardized global processes for document management, training management, quality events and change control. 

Eisai previously used the TrackWise on-premises solution to manage quality processes including corrective actions and change control. The company continues to automate these key quality processes since conversion to TrackWise Digital.

THE SOLUTION

Transforming Quality through TrackWise Digital Conversion 
Ryuichi Yamasaki, Eisai’s Senior Director of Data Integrity, said “What matters most before implementing a new software solution is to create a global, common process for each item. This means that only one process for each item should exist in pharmaceutical companies.” 

“It’s also important to effectively structure the project organization,” Yamasaki says. “This included the project leader, teams for business processes and IT, the TrackWise Digital team and partner, in this case Hitachi.” 

TrackWise Digital is being used across various departments within the organization, including quality management, IT, the production division, laboratories, R&D and sales. 

Eisai will use TrackWise Digital to manage the following processes: 

• Nonconformance 
• Deviations 
• CAPA 
• Change Control 
• Document Management 
• Training Management 

THE RESULTS

Unified Business Processes and Cost Savings 
Eisai’s mission is to create a corporate quality control policy and build a corporate-level IT infrastructure strategy. The most important thing is to promote these activities to strengthen data integrity. This is where TrackWise Digital comes in. 

Since introducing TrackWise Digital, the difference has been clear. It has resulted in unifying Eisai’s business processes. The ability to do this on a global scale, means that large pharmaceutical organizations across the world have access to it. Managing key processes like document and training management in a single platform has also increased Eisai’s competitive advantage. 

Yamasaki said “TrackWise Digital has resulted in single QMS for our company. In doing so, we and other pharmaceutical companies that implement an integrated system can expect to see cost savings in the introduction of TrackWise Digital, annual upgrades, users account fees and technical services. Additionally, if common reports, like change control list, deviation list, CAPA List, quality management report, and more are prepared, pharmaceutical companies will gain an advantage for the authority’s inspection readiness.” 

TrackWise Digital will also support Eisai’s need to be in line with patient’s needs in HHC and prevent delays in delivering products to the end patient, by taking a proactive approach to quality. Of this partnership, TrackWise Digital Sales Director Yasuhiro Watabe says, “Over the last 25 years we have been providing solutions to our customers. I believe with the knowledge cultivated there we were able to contribute to Eisai’s business.”

LOOKING AHEAD 

Global expansion is next for Eisai. By 2024, Eisai plans to roll out TrackWise Digital to all 12,000 users in the business. 

TrackWise Digital will be there to support Eisai in its global quality management efforts, enabling the company to focus on its HHC mission, and bringing the ultimate value to its patients. 

Eisai’s Senior Director of Data Integrity, Ryuichi Yamasaki, sums up the feelings about the system, saying, “There’s nothing that can’t be achieved without the addition of TrackWise Digital.” 

From ensuring a high level of quality and safety for the patient to ongoing patient advocacy efforts, Eisai continues to live by its HHC stance and put the patient first. Investment in the TrackWise Digital system is a testament to Eisai’s efforts to keep quality and safety at the forefront of all quality management activities.