How compliance is ensured with BizzMine at Staxs

CAPA Management Document Control Calibration Management Medical Devices

Staxs is a leading provider of cleanroom consumables for the pharma and life sciences industries. As experts in contamination control, they have earned an excellent reputation for the quality and reliability of their services and products such as hoods, gloves, masks, disinfectants and cleanroom wipes. 

As quality is at the heart of their processes, a digital quality system is a must. Staxs chose BizzMine because the system is viable and scalable.

For Staxs, BizzMine is the best of both worlds: the software fully meets our requirements without being too complex.

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.

Why BizzMine

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.




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