Fagron’s Key to Quality Alignment: Extending QMS Capabilities

One of the toughest challenges faced by companies with geographically dispersed business units is maintaining process and product quality consistency. That’s why Fagron, a leading global pharmaceutical compounding company, has made it a top priority to standardize quality processes across all 66 of its worldwide sites. The primary driver behind the company’s efforts to achieve global quality harmonization has been the expanded use of its cloud-based MasterControl quality management system (QMS).

“Phasing our implementation of MasterControl has always been the strategy,” said Fagron North America Quality Specialist Matt Seitz-Paquette. “It has helped us standardize processes across the sites that have adopted it.”

Driving Success Exponentially

A monumental accomplishment like centralizing multiple sites’ quality management operations within a common digital platform doesn’t happen by flipping a switch. Fagron’s quality team started by implementing key MasterControl quality solutions in the company’s sites in Florida, Kansas, Minnesota, and Nevada. The game plan from day one was to expand the use of the system to other locations as each business unit achieved desired outcomes.

“Obviously we can’t implement at every site all at once all around the world, so we are doing it in chunks,” said Seitz-Paquette. “Since everything else comes down to documents and training — the most basic elements of MasterControl — we chose to start there and build upon it.”

One out of every three Fagron employees — nearly 1,000 people — now use the system. The cloud-based QMS’ capabilities have been extended to 11 different global sites to date, and more implementations are imminent.

“It’s always been the plan to implement as many MasterControl modules as we can in as many sites as we can,” Seitz-Paquette said. “We’re just always adding. And now we have several more sites queued up to implement in EMEA: Croatia, Greece, Israel, South Africa, and Spain.”

As each new site implements the system, it’s becoming easier to get them up to speed with the enhancements, according to Seitz-Paquette.

“It actually helps us accelerate adoption when we have perfected one site and can roll that out to others,” he said. “When the first groups of companies in the U.S. rolled out the modules for managing documents and training, we were creating all that configuration from scratch — our life cycles, roles, and everything. Now when we add additional sites, we can just copy the configuration structure. We don’t have to figure out how to organize life cycles and roles.”

How Quality Uniformity Benefits the Bottom Line

Newfound quality efficiencies have helped Fagron achieve unprecedented gains in key performance areas such as:

• A 50% reduction in deviation times.
• Right-first-time metrics improved to 100%.
• More than 200 new or revised documents going into effect every month.
• An average of 1,000 training tasks distributed at each site every month.
• Users worldwide viewing documents in the system approximately 18,500 times per month.

The expanded use of the QMS is also helping more Fagron sites eliminate waste and reliance on paper.

“We have nearly 10,000 released documents in our system right now — just released documents alone,” Seitz-Paquette said. “Imagine if that was all paper! Think how transformative it has been that we can now look at a document digitally and trust that people aren’t making unauthorized changes to things.”

The Next Level of Process Standardization

Process alignment has never been more critical for Fagron now that the company has an average of 200-plus new or revised documents going into effect every month. Having a holistic process management solution as a cornerstone now ensures users at each site are on the same page. Plus, it streamlines the management of the corrective action / preventive action (CAPA), deviation, training, and other processes that are vital to the company’s quality successes.

“Before, everybody had their own CAPA and deviation procedures,” Seitz-Paquette said. “Now, as we’re adding sites, they’re following the same standard processes at all sites.”

Expanded access to the cloud-based QMS has made it possible for more Fagron employees to share a single, harmonized system, regardless of their location or time zone. It’s provided the assurance that all designated personnel can access the most up-to-date versions of standard operating procedures (SOPs), training documents, work instructions, and other documentation. Seitz-Paquette said the optimization of quality event management in general has been a significant benefit.

“Overall, the time it takes to handle quality events has been reduced because everything automatically goes to the right person,” Seitz-Paquette said. “We’re not trying to hunt down people with a paper form.”

Additionally, Fagron’s drastically improved reporting capabilities are driving a more targeted approach to CAPA management.

“By encouraging quality reporting, we have more data to analyze events and understand trends,” Seitz-Paquette said. “We’re maximizing the use of the event report and taking advantage of the closed-loop nature of the system. It’s given our people access to quality, really — putting it in their own hands so they can report on anything. That allows quality personnel to escalate as appropriate and to identify trends, so we’re not launching a CAPA for everything. We only do CAPAs on the highest-risk things or specific trends we’ve identified, and everything gets resolved in a closed-loop system.”

Laying the Groundwork for Future Growth

The efficiencies that have been gained with each additional site’s MasterControl implementations are helping reinforce Fagron’s goal to add more solutions at more sites as quickly as possible. Seitz-Paquette said MasterControl postmarket and customer complaint solutions are currently being configured to meet Fagron’s business needs. And once system access has been rolled out to more sites, Fagron also plans to implement MasterControl audit and supplier management solutions.

“We have a whole road map and we’re just at the beginning,” Seitz-Paquette said. “We’re planning on implementing more modules, but we have to give more sites access to the system before we can do that. We’re just going to keep going!”

To learn more about the many ways Fagron is benefiting from extending its QMS capabilities, download the case study. You can also view an on-demand webinar in which Seitz-Paquette highlights the advantages of expanding quality throughout an organization’s broader ecosystem here.