CASE STUDY

CORTRIUM

 

ENHANCED EFFICIENCY

Cortrium is a Danish med-tech company, producing medically certified ambulatory ECG monitors, which offers a faster and easier way of screening patients for heart arrhythmia.

The company was founded in 2014 and has obtained the EC certificate (CE-mark) and ISO 13485:2016 certification. Today Cortrium’s products are sold in multiple EMEA markets and they have partnered with Pfizer Pharma to further commercialize their products.

During the implementation of SimplerQMS, the expectations of SimplerQMS’s team have been exceeded. We have got a lot of help – also on awkward hours of the day. So definitely the whole team and the support behind have been amazing.

Louise Flintegaard Ehlert

QA Process Manager, Cortrium

WHY CHANGE TO AN EQMS?

Cortrium faced a common problem in growing companies, maintaining an efficient Quality Management System, without overloading the Quality Assurance department.

 “In Cortrium we grew from a handful of employees to plus 20 employees within a very short time. This meant we needed to implement a more efficient Quality Management System, to keep control of our documents. We also wanted the people using the QMS system to take ownership of the documents and not only QA,” says Louise Ehlert, Process Manager at Cortrium.

 Switching from a manual Paper QMS to the ISO13485:2016 certified, Part 11 Compliant SimplerQMS system allowed Cortrium to minimize workflow disruption, caused by the constant change in their workforce. Furthermore, it represented the opportunity to simplify their procedures and forms, which provided both efficiency and quality benefits to the organization.

POST-MARKET TOOLS IMPLEMENTED IN 4 WEEKS

Shifting from a manual paper-based system to an eQMS can be an overwhelming process without the right support and planning. Cortrium relied on the extensive cooperation and support from the SimplerQMS team. This support included training, assessment of IT systems readiness, and system validation. The support provided to Cortrium, as is the case of all SimplerQMS`s customers, was provided at no extra cost.

“During the implementation, the cooperation with the SimplerQMS team was excellent. We had regular meetings with the team, and they were always available to support us – which is also the case after going live on the system,” says Louise Ehlert, Process Manager at Cortrium.

Cortrium followed SimplerQMS`s formula of incrementally implementing the eQMS system. This is done to avoid a “big-bang” project, where too many people and processes are involved in the process. In this way, Cortrium started harvesting the efficiency benefits in a matter of weeks instead of waiting for many months.

“The first project included all our technical files, procedures, and templates. Then we took it step-by-step, and finished implementing the Post-Market Surveillance Tools, adapting all our procedures and templates in just 4 weeks,” says Louise Ehlert, Process Manager at Cortrium.

Cortrium`s advice for successfully implementing SimplerQMS:

  • Dedicate a specific project manager to the task
  • Be critical of the documents that will be migrated to the eQMS, this an opportunity to clean-up your archive
  • Implement step-by-step, procedures and forms first. Then technical files and Post-Market Surveillance.
  • Involve the IT manager in the process, this is to ensure that AD synchronization and Microsoft Azure are aligned

EASY ON-BOARDING OF NEW EMPLOYEES

For a rapidly growing company, saving time has been the greatest benefit of using SimplerQMS. The constant growth of files and procedures places the Quality Assurance department under enormous pressure. SimplerQMS allowed for the needed overview and control of the procedures, easily assigning tasks to employees. Access to the system can be modified according to the responsibilities of the employee, allowing for a more organized work structure.

“Using SimplerQMS, when we onboard new employees, we just assign them a role and it will automatically tell the new employee which procedures and templates he or she is responsible for,” says Jacob E. Nielsen, Co-Founder & CPO at Cortrium.

All documents are stored in an easy to access user-interface, instead of paper binders, allowing for easy access. Another benefit of changing to an eQMS was keeping track of document versions, ensuring the use of a document’s most recent version.

“An eQMS like SimplerQMS has decreased the number of human errors of getting around procedures or obsolete templates,” says Jacob E. Nielsen, Co-Founder & CPO at Cortrium.

DURING THE COVID-19 EPIDEMIC

Operating in a highly regulated sector, Cortrium`s employees need access to large amounts of documentation, and efficient coordination between areas of the company to guarantee their compliance with regulatory requirements. A paper-based system already possesses its challenges when working at the office. These challenges are magnified when there is a need to coordinate and ensure the efficiency of a geographically dispersed workforce. By switching an eQMS, Cortrium was able to mitigate most of the problems caused by remote working.

“During Covid-19 it was nice to have everything online in a validated system, so we didn`t need to physically access our archives. It made it easy to automatically assign new templates and procedures to the right people,“ says Louise Ehlert, Process Manager at Cortrium.

SHORTER COMPLAINTS PROCESSING TIME

Currently, with SimplerQMS fully implemented, Cortrium has experienced great gains in productivity, saving-time compared to their previous paper-based system. Co-working has been greatly improved, even with the rapid growth of the company.

“In a growing company, saving time on documentation is not easy, but if we had continued with a paper-based system, we would be using much more time,” says Louise Ehlert, Process Manager at Cortrium.

From all the benefits obtained from switching to SimplerQMS, Cortrium underlines the Post-Market Tools. These tools helped to improve the collaboration between areas of the company, resolving complaints more effectively and easily.

“After going live with the Post-Market Surveillance Tools, we had people in customer support asking if they could also use the complaints forms as soon as they became available, and they found them very easy to use. We have shortened the processing time, with the test team getting notified as soon as a complaint is received,” says Louise Ehlert, Process Manager at Cortrium.

CORTRIUM CASE FACTS

  • Cortrium is a Danish med-tech company, producing medically certified ambulatory ECG monitors, founded in 2014
  • Management: COO, Jacob Eric Nielsen
  • Website: www.cortrium.com
  • SimplerQMS Modules: Document Control, Design Control, Equipment Management, Supplier Management, Customer Management, Training Management, Post-Market Surveillance