Experiences from two TrackWise Digital customers, Arbor Pharmaceuticals and Mikart, Inc., highlight the challenges that companies can face when it comes to document management in the pharmaceutical industry.  

Arbor is a virtual pharmaceutical manufacturer with over 40 contract manufacturing organizations (CMOs) and more than 400 change control records per year. The company relies on its quality management system (QMS) to streamline document approval and storage for improved stability control. 

Mikart, a recognized CDMO leader since 1975, provides pharmaceutical development, contract manufacturing, and packaging services to virtual and midsize pharma/biotech companies offering state-of-the-art technology and expertise. The company underwent a digital transformation initiative that included a fresh look at quality management system needs.  

The Need for a Change  

Both companies were looking for a solution for creating, reviewing, approving and storing documents, while also ensuring that they were easily accessible to those who needed them. 

They found the solution they were looking for in TrackWise Digital. One of the key challenges that Arbor Pharmaceuticals was facing was using an approach that combined a manual, paper-based change control system with a resource-intensive document management system.  

Mikart was looking for technology that would shift quality from being paper-based to digital. Too much time and human capital was being spent on routing documents for approvals and signatures, by foot, across their sites at their sprawling, multi-building campus.  

Reaping the Benefits  

With TrackWise Digital, Arbor and Mikart were able to automate their document management processes, making it easy to create, review, approve and store documents.  

Arbor’s users now access TrackWise Digital daily to review and approve documents. And those workflows now look quite different. As a result, Arbor has been able to improve both timeliness and efficiency.  

For Mikart, TrackWise Digital has provided a secure and central repository, accessible by mobile phone and an approval process that could have taken 2-3 days now can take place in less than a day.  

Simplifying Document Management with TrackWise Digital 

These two case studies highlight the challenges that companies can face when it comes to document management in the pharmaceutical industry. Both Arbor and Mikart were able to improve document management while integrating it with their overall quality management processes using TrackWise Digital. 

So what do they have to say about the results?  

“When people have questions now, they’re usually about internal procedures — not how to use the QMS software,” says King. “I don’t think anyone would choose to go back to the old system now. TrackWise Digital makes life easier. I only wish that all of our CMOs were using it.”  

Quality Operations Analyst at Arbor  

“It would take two to three days to get an investigation approved, running a document from site to site, person to person. In TrackWise Digital, it can go to everyone at once, throughout the buildings, even if they’re working from home, or taking a business meeting in a different state.” 

Director, Quality Operations at Mikart  

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