How we Saved a medical device company time, compliance headaches and money

Written by Rina Nir

Device compliance achieved

For international health industry companies, ensuring regulatory compliance is difficult. Add into the mix an outdated paper-based Quality Management System (QMS), and the task to meet regulatory requirements across multiple locations in an efficient, cost-effective, timely manner becomes impossible – and threatens to derail a busy, successful international organization for non-compliance.

The challenge

An in vitro diagnostics (IVD) medical device and clinical lab organization with offices in the U.S. and Europe desperately needed a new QMS to better manage a vast quantity of paperwork. Beyond the risk of non-compliance, it was a daily challenge to ensure that procedures were standardised and the latest documents were being referenced. For example, thanks to differences in time zones and schedules, it wasn’t unusual to lose days worth of productivity over small things, such as a signature or an approval. Furthermore, paperwork they relied heavily on — Document Approval Forms — was comprised of two separate documents so staff members had to manage both simultaneously and track down printed copies to be sure they matched. And other everyday necessities, such as internal complaint tracking, corrective action tracking, resolution, and personnel training, were also needlessly complicated by the antiquated paper-based QMS. This led to perhaps the biggest issue of all: training new personnel to use this inefficient system, which was riddled with complicated processes for handling simple tasks. Although this company had explored other options to update their QMS, none were successful. Understandably, management was a bit reluctant to try again for fear of another failed attempt. But internal complaints about using the paper-based system were mounting; the time had come to make compliance-related processes easier, using a customised solution that was simple to use and implement company-wide.

The process

After examining numerous options, the company’s Vice President of Regulatory Affairs and Quality settled on Jira as the base software for its digitised QMS because not only is it “the biggest name in bug tracking in the software industry,” but also because it’s user-friendly and is continually being updated and improved. He then retained us to customize the software so that it was easy to implement a new, streamlined QMS company wide. Topping the list of the VP’s priorities was to make the system user friendly, so the learning curve for new staff would be minimal. Working from a flowchart of how the company wanted the electronic system to behave, we implemented the system in a staging environment – starting with a customised change control form module that would standardise our client’s controlled documents into one easy process. Once approved, we uploaded the company’s hundreds of CCFs and numerous additional documents in just two days. The final step to completing the digitised QMS was to develop a custom training management module, which made all types of training accessible and intuitive, from HR practices to department-specific processes. Beyond the benefit of saving the company significant time — thanks to the module’s ease of use — the training management module also allows the company to clearly demonstrate to auditors that all staff are properly trained on necessary procedures.

The results

The Senior Vice President of Regulatory Affairs and Quality estimates 500% more regulatory compliance efficiency and a resource cost savings of $150,000- $200,000 annually. Today 75 employees have access to the electronic QMS and rely on it daily. In less than a year, over 700 CCFs have been processed through the new system – and internal complaints about using the QMS are a thing of the past. “We deployed our new quality management system from start to finish over a few months, for a fraction of what other systems cost,” the Senior Vice President of Regulatory Affairs and Quality raved. For more details, read the full case study.

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