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.
Cortrium Video Testemonial
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.
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
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.
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.
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.
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.
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.
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.
✓ 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.