Why we needed a digital qms
Compliance with rules, regulations and ISO standards is becoming more and more important and is imposed on the industry, which is normal because human lives are at stake.
That's why we needed a system to monitor and record our standards for ISO 9001, ISO 13485 and GMP. It allows us to describe what changes we make to our system and how this is documented.
The automatic periodic reviews that the system performs are a great help to us. They let us know exactly what we need to approve and when.
Quality is at the heart of our processes, so a digital quality system is a must for us. We love BizzMine because it is a system that is viable and scalable.
BizzMine is a very reliable and transparent system:
- We are always well prepared for our audits.
- Our IT team gets very few questions and does not have to report any incidents related to the software.
- We have moved to a cloud-based environment, so all employees can access the system from different departments and countries, no matter where they are.
For our company, BizzMine is the best of both worlds: the software fully meets our requirements without being too complex.
The solutions we implemented in BizzMine
The document control module allows us to control our work instructions, SOPs, contracts, NDAs, data processes agreements, and changes we make as part of our management of change process. These documents must be documented and stored in a quality system for authorities and ISO standards. Our employees who work in our cleanrooms must sign to acknowledge that they have read the regulations and are aware of our procedures.
Flows for managing CAPA and calibration are also set up in BizzMine. Our calibration systems such as scales and sterilization machines must be validated at specific intervals to ensure they meet standards and that deviations are allowed. This is also fully documented in BizzMine.
The benefits of BizzMine in a nutshell
The visibility and traceability of our procedures
Because our documents are so easy to view, we are much better prepared for audits. And also, the auditor asks us much fewer questions. Only the documents themselves need to be audited, not the system.
The software is user-friendly and instantly deployable
As an end user, you need very little IT knowledge to work with BizzMine. It is a very transparent and intuitive system.
The system is easy to maintain
Our IT team has little to no need to maintain the system as it is straightforward and stable.
We have a very reliable quality system
Our QA department does not have to worry about the availability and reliability of our quality system, because BizzMine scores very well on these parameters.
The software saves us a lot of time
We do not have to send separate mails and check who did what. We simply don’t waste time because the automated system works for us.
We get excellent support
The BizzMine team gives us clear and timely support. Our transition from on-premises to the cloud was a piece of cake, which is certainly not always the case in the IT world.
Kristof Lannoo - IT Manager
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Staxs video testimonial. Watch and learn how Kristof explains which benefits BizzMine has brought.