Abacus Medicine headquartered in Denmark, supplies original prescription medicines in Europe through parallel distribution or parallel import. Its business model is based on the core principle of the free movement of goods in the EU’s single market. 

Like other organizations in the Life Sciences, Abacus has many regulations to comply with, such as good manufacturing practices (GMP) and good distribution practices (GDP), making an end-to-end enterprise quality management system (EQMS) even more critical. Digital EQMS solutions enable organizations like Abacus to ensure its medicine products are of the highest acceptable quality.

As Abacus grew and more sales markets were added, the existing manual processes did not meet the company’s needs. This is what prompted the need to implement a QMS, and brought the company to TrackWise Digital.

THE OPPORTUNITY

Innovating with a Digital EQMS 
Abacus was previously using a manual, paper-based system to manage its quality initiatives. Solutions like Excel and Word were used to manage all records and standard operating procedures (SOPs). However, the increasing complexity made it challenging to control and monitor these processes, as well as other downfalls of a manual system, including accessibility.

There was also a challenge in extracting the data to make sense of it, hindering the company from using this data to drive fast and efficient decision making. The company was working double-time to make its quality solution meet its business needs. Abacus recognized that it needed a more intuitive system that would work for them and help drive process efficiencies.

THE SOLUTION

Digitize Quality Management with an End-to-End Globally Recognized Solution 

Greater Control and Remote Access 
Since implementing TrackWise Digital, Abacus has seen tremendous improvements in control over its data. It is now easier to gather the information needed by accessing all records through TrackWise Digital online rather than using paper documents onsite.

This came at just the right time. In a post-pandemic business environment where many teams are distributed and working remotely, Abacus has been able to benefit from TrackWise Digital’s capability to manage quality anywhere at any time.

While this was not within their plans, in terms of needing remote access to quality, Abacus’s TrackWise Digital Administrator Jeffrey Rong Chao Quach says, “this was a tremendous upside.”

Cloud-based Collaboration and Electronic Signatures 
The system is cloud-based which enables multiple sites to get access to it and provides a direct way of working and standardizing procedures. With a large quality assurance team of around 100 employees, this was essential.

Abacus implemented the out-of-the-box TrackWise Digital package and added a few specific requirements. Having greater control over quality processes and ease of use has been a huge benefit. In fact, Quach, says his favorite feature is eSignature. “I can [electronically] sign off records from home, rather than printing and signing,” he says.

Capabilities like this add up in terms of ease and show the tremendous benefit of a solution that enables remote work.

Abacus uses TrackWise Digital’s automated reporting features globally for monthly key performance indicators (KPIs) and Quach says, “in general the whole company has undergone a change in the way we monitor and look into KPIs.” 

THE RESULTS

Digital Quality Drives Efficiencies, takes the Labor out of Quality Management 
Abacus can now pull reports quickly and easily and has improved the process of searching for data. Records can be found at the click of a button, reducing the time needed to access these documents.

“I would recommend that if you currently have a paper-based quality system to switch to an electronic, cloud-based one—it’s the future,” says Quach.

The solution was primarily used by the Quality Assurance team but as the company has grown, more departments across the company have been accessing the system.

LOOKING AHEAD

Abacus currently has 100 user licenses but has plans on getting access for its entire organization. “The idea is to have everyone involved in the process use the system,” says Quach.

Quach is extremely happy with TrackWise Digital and finds that to be the same across Abacus, saying emphatically that “everyone is satisfied with the system. We can easily reach out and support has been great and the team has been available when we need them.”

Abacus’ website states that the company is “innovative, dedicated and we care.” The company’s investment in TrackWise Digital emphasize this point and shows Abacus’ focus on the end customer—the patient.