CASE STUDY:

CORTRIUM

Who is Cortrium?

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.

 

 

Product: C3+ Holter Monitor

Industry: Medical Device

Company Size: 25 employees

Development Stage: Commercialized Product

Goal: Faster Processes and Better Document Accountability 

 

 

During the implementation of SimplerQMS, the expectations from 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

Cortrium Video Testemonial

eQMS Implementation

Preparing for Implementation

Before we started to implement SimplerQMS at Cortrium we had several meetings with key stakeholders. These meetings mainly revolved around Cortrium’s Quality Management System and its established operational procedures. We agreed that the main focus points of the eQMS are:

Rapid Growth Management:

Cortrium was growing rapidly and faced an increasing demand for working streamlining operations. The constant growth of files and procedures placed the Quality Assurance department under enormous pressure. This resulted in a slowed down progress and processes that were limiting Cortrium’s growth options.

Ownership and Responsibility for documents

Limited traceability and overview of the paper-based QMS meant that only a handful of QA employees were responsible for the handling of documentation. Cortrium wanted a system that would increase personal accountability and ownership of handled documents for every employee.

Remote Friendly eQMS to Tackle Covid-19 Restrictions

Operating in a highly regulated sector, Cortrium’s employees needed 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.

Implementation Process

Cortrium followed SimplerQMS’s formula of incremental eQMS implementation. The process of incremental implementation divides implementation into multiple phases. Together with Cotrium, we planned out all of the phases to balance essential processes and fast to implement features. In this way, Cortrium started harvesting the efficiency benefits in a matter of weeks instead of waiting for many months.

 

Implementation Tips from Cortrium:

  • Dedicate a specific project manager to the task
  • Be critical of the documents that will be migrated to the eQMS, use this as an opportunity to clean-up your archive
  • Implement step-by-step, procedures and forms first. Then technical files and Post-Market Surveillance.

The last phase of eQMS implementation typically involves validation. However, SimplerQMS is Pre-Validated. This was also one of the reasons that Cortrium chose our eQMS solution. Validation is a process of functional software testing that needs to be completed before companies complying with ISO 13485:2016, 21 CFR Part 11 and the GxP Requirements can use the eQMS. Our pre-validated software allowed for a shorter implementation and smoother shift to an eQMS.

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.

Louise Ehlert

QA Process Manager, Cortrium

Cortrium finally transitioned to the following SimplerQMS modules:

  • Document Control
  • Design Control
  • Equipment Management
  • Supplier Management
  • Customer Management
  • Training Management
  • Post-Market Surveillance

Training and Support

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.

Louise Ehlert

QA Process Manager, Cortrium

Results

Increased Procedure Ownership

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.

Jacob E. Nielsen

Co-Founder and CPO, Cortrium

Seamless Remote Work

By switching to an eQMS, Cortrium was able to mitigate most of the problems that commonly appeared during remote working. SimplerQMS made it easy to share documents, create new procedures, or automatically transfer assignments. This allowed for a seamless remote work experience and smoothly running processes.

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.

Louise Ehlert

QA Process Manager, Cortrium

Major Productivity Boosts

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.

Louise Ehlert

QA Process Manager, Cortrium

Shorter Complaints Processing Time

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.

Louise Ehlert

QA Process Manager, Cortrium

Minimal Workflow Disruptions

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

 

Cortrium appreciated:

✓ Fast Implementation

✓ Increased Productivity

✓ Reliable Customer Support

✓ Increased Procedure Ownership

✓ Online QMS Workflow

SimplerQMS has decreased the number of human errors of getting around procedures or obsolete templates.

Jacob E. Nielsen

Co-Founder and CPO, Cortrium