Product: Skin Analysis and Cryotherapy Instruments
Industry: Medical Device
Company Size: 20 employees
Development Stage: Commercialized Product
Main Goal: Better Traceability of Documentation
Cortex Case Study
Cortex specializes in the development and manufacturing of high-end instruments for skin analysis and cryotherapy. Founded in Denmark, they have been serving dermatologists and researchers for more than 30 years.
Their quality management system is ISO 13485 certified, and all of their products have obtained a CE mark. Cortex was looking for an eQMS solution that would provide them with better document traceability and increase the efficiency of their workflows.
Throughout the whole process, and still, we feel that we are in very good hands. We have full faith in the system and the feeling of being safe in terms of our QMS is the best way I can put it.
Paper Trouble
Traceability and Lost Documents
A company with 30 years of experience and several products has a lot of documents. It would not be rare to see a person spending a lot of time trying to find crucial documents. Occasionally, documents would get lost.
In such cases, they needed to be replaced which produced an even bigger operational burden. Furthermore, when workflows and processes went through multiple individuals it was hard to always keep track of responsibilities within the teams and it was hard to see which person is currently handling what tasks.
Access To Documentation
The access to documentation was another problem. Some employees were not in the office every day due to travel or other reasons.
In such cases, it was hard to get a signature, and the whole process or workflow needed to wait for the person to return and sign or review the document. The waiting was even longer when the document required several signatures.
The situation got naturally even worse with Covid-19 restrictions. To become more effective, Cortex needed a solution that would allow their employees to securely access documentation from anywhere.
Foundation For The Future
Another reason for the implementation was to set a strong foundation for future projects. The management knew that a smoothly running quality management system is a necessity when the company wants to focus on R&D and new products.
They were looking for a solution that would allow them to create a solid and efficient system that can support Cortex in the future.
Implementation Goals
Increase Traceability of Documentation
Build Strong QA/RA Foundation For Future R&D
Save Resources and Time
Increase Efficiency of Workflows
Allow Access to Documents From Anywhere
eQMS Implementation
To allow for a smooth and efficient transition from a manual quality management system to an eQMS we held meetings with Cortex to determine the scope of the implementation.
At this point, we discussed and explored the existing QMS, the company’s workflows, the responsibilities of the team members, and other necessities.
We made a plan with Jacob and he was on top of that plan at all times. He made sure we met our deadlines, and he was very good at getting us to the point where we could get to the implementation.
This allowed us to start an implementation that was aligned with Cortex’s expectations and needs. Based on these meetings we created a plan that had 2 phases.
Typically, we try to spread the implementation into 3 phases to smoothen the transition and create as little disruption to the day-to-day workings of the company as possible. However, since Cortex needed to implement the solution before the 26th of May, we agreed on 2 phases.
It is typically better to introduce at least 2 implementation stages to decrease the pressure on the organization and its operations. In practice the employees can then still use parts of the old QMS, while gradually transitioning to the SimplerQMS modules.
From SimplerQMS there was a big emphasis on making sure that we met the deadline and that we achieved what we wanted.
The workload and time that would need to be invested into the implementation was the main concern that Cortex had.
Lots of vendors account for additional fees during this process which may significantly increase the price of the software as well. However, together we were able to draft a successful plan that allowed cortex to maintain their wished deadlines.
Training and Support
Cortex underwent regular training sessions that are provided together with the implementation. First, they had a lecture-style overview of the system and its possibilities which was followed by hands-on training overseen by our training coaches.
When it was apparent that all the participants can handle the system at a high level, we issued training certificates and finalized the training.
We were really happy with the support. It has been fast, pleasant, and efficient.
As with all of our customers we provide Cortex with unlimited support during office hours.
For example, one time Christian was struggling with creating a complaint document within the system.We quickly identified that it was caused by improper user rights settings. He called us and 5 minutes later he could easily continue his work.
As a part of the support, we also assisted Cortex during an audit when it came to the questions about SimplerQMS certifications and its viability for the storage of records.
Results
More Than 50% Time Reduction
Finding documentation, making changes to the records, signatures, reviews, oversight, and other tasks now take less time. Change Management assignments that used to take 3 hours now take 15-20 minutes.
QA/RA Tasks Are More Visible
When QA/RA is done right it might be sometimes difficult for other departments and colleagues to see the nature of the QA/RA tasks. Thanks to SimplerQMS, Dorthe’s colleagues can now see how she contributes to the organization and what role does QA/RA play in their day-to-day tasks.
I was doing a lot of things behind the scenes, a lot of things that were invisible to most of my colleagues, and now they see them. Now they realize what I was doing.
Smoother and Easier Audits
The preparation time for audits significantly decreased. Instead of fetching different documents, employees can easily search for documents in the system and show them to the auditor.
To prepare for FDA inspections, Dorthe spent hours scanning documents and then sending them via multiple emails. Now she can just give auditors access to the system.
Easy Document Access
The documents are now safely and easily accessible from any office and location. Colleagues are able to share tasks and records very easily and the times when Cortex had to wait multiple days for a signature are practically gone.
It’s very easy to keep track of everything, have the whole history of all products accessible for anyone at anytime, its very easy to hand over a process, complaint, non-conformance, or change from one person to another. It’s very flexible and smooth and easy to use and naturally, documents don’t get lost.
High Level of Traceability
Another result of the implementation is that documents don’t get lost anymore. The employees don’t have to go through hundreds of binders to find a particular piece of paper. They just type the name of the document in the search box and click on it.
No papers disappear. There are no more accidents where we would need to recreate documents. Even if my computer breaks down, the documents are still there.
Increased Task Ownership
The system makes it very clear which team member has what tasks. Employees can be prompted for specific responsibilities, and they can often do them at their own pace which results in better efficiency of the workflows.
Significant Reduction of The Human Error
The chances of human error drastically decreased. Since all of the documents are now safely stored in cloud storage there are no incidents with spilled coffee or misplaced files.
The chance of a human error in the process of filling out documents has been reduced. There is a number of different human errors that have been eliminated and we feel like the system helps us to catch possible human errors more easily.