ZenQMS Simplifies Workflow Configuration for Nordic Pharma Inc.

Nordic Pharma’s Leap from Paper to Digital 

Nordic Pharma provides high quality, safe medications, and medical devices to a global patient population. However, in order to continue their mission, they realized the quality tools they used were in need of an upgrade. When the Vice President of the Quality Unit, Nancy Fulginiti arrived, she aimed to bring their quality management system up to modern standards to meet the dynamic needs of the company and ensure strict regulatory compliance.

Her first task? Move the company away from paper wrought with limitations around accessibility, efficiency, and organization. A move to shared cloud drives for storing documents and SOPs was a step forward, but still insufficient. As any quality professional will tell you, shared drives lack accountability and are not compliant with 21 CFR Part 11. 

Thus, the decision was made to explore electronic quality management systems (eQMS) that could not only keep their operations organized, but also meet and maintain regulatory compliance requirements. In particular, they were searching for an eQMS that would allow them to build their unique workflows. 

“One system we looked at was an ‘out-of-the-box’ solution,” said Marie Myers, Nordic Pharma’s Quality System Manager. “That sounds good, but when you have to use it for all of your quality systems, it’s not going to match every company’s needs. We have a lot of specific workflows we want to track, but that’s not possible to do with other business solution software.”

“During our first post-implementation FDA inspection, we were able to quickly and efficiently provide the requested documents. Nordic Pharma’s quality of documentation control process with ZenQMS was appreciated by the FDA inspector as expressed during our Management closeout.” 

With their need for strict compliance, highly configurable workflows, and improved efficiency, ZenQMS was a clear fit. After the transition to ZenQMS, Nordic Pharma immediately realized the benefits. Compared to shared drives, ZenQMS offered better visibility and company-wide accountability, and the system’s automated notifications clarified responsibilities and deadlines for the entire team.

“It’s really user-friendly,” said Marie. “When we rolled out ZenQMS, it was a learning curve, but once we completed our training and understood the workflows and requirements, everybody came back and said, “Oh, this is so much better.” 

ZenQMS wasn’t just a hit with Nordic Pharma employees. Regulatory inspectors also noticed the improvement in the readily available documentation.

“During our first post-implementation FDA inspection we were able to quickly and efficiently provide the requested documents,” said Marie. “Nordic Pharma’s quality of documentation control process with ZenQMS was appreciated by the FDA inspector as expressed during our Management closeout.”

Workflows that match your preferences

Nordic Pharma's search for an effective eQMS led them to evaluate several solutions, with ZenQMS emerging as the preferred choice due to its configurability and user-friendly interface. Panos Boudouvas, CEO of ZenQMS, provided a compelling presentation that showcased the system's ability to manage complex quality scenarios. Additionally, the platform's ability to consolidate their quality systems in one place, coupled with its top-tier customer service, made ZenQMS stand out from the competition.

“To build these workflows, we needed little assistance from ZenQMS.” 

Marie immediately realized that the primary advantage of ZenQMS is its configurability. Nordic Pharma had unique, yet critical workflows they wanted to launch for Field Alerts, Investigations, and Commitments that out-of-the-box solutions simply couldn’t accommodate due to their rigidity. 

“The forms we’ve created in the ZenQMS Issues module aren’t anything we could’ve built in another system that I’m aware of,” said Marie.

But perhaps the real differentiator of ZenQMS is empowerment. Sure, a configurable eQMS is helpful, but with ZenQMS, not only could Nordic Pharma design processes to address their specific operational needs, but creating new workflows was simple, bypassing the delays that come when dealing with internal and external support.

Transforming quality management from manual chaos to digital precision doesn’t have to be difficult. Nordic Pharma’s experience with ZenQMS proves that efficiency and compliance can go hand in hand with simplicity. Ready to rewrite your quality narrative? Schedule a demo with ZenQMS and find out how we take the stress out of eQMS.