Compliance with cGMP is easy with Bizzmine at CARBOGEN AMCIS

Why we needed a digital qms

Before the implementation of Bizzmine, all our quality processes were paper-based. This had the disadvantage that there was no control over the execution of the processes, documents could get lost, and there was no linkage between the processes. Also, creating an up-to-date status of the quality processes was time-consuming. In that way it was difficult to meet the high standards of pharmaceutical production legislation and to comply with cGMP, ISO, and FDA requirements.

Why BizzMine

One of the biggest advantages is the flexibility of Bizzmine. You don't need to adapt business processes; Bizzmine adapts. So implementing Bizzmine only requires training in the software itself, not for the business processes. After all, these remain the same.

Furthermore, the insight into process traceability is a big plus.

The solutions we implemented in BizzMine

The Bizzmine workflow module has made our processes for CAPA, MoC, complaints and deviations paperless and compliant with the requirements of 21 CFR Part 11 (Electronic Signatures).

We can also use the software for applications that are not quality-related. We found out that a workflow for our CAPEX (Capital Expenditures) is easy to arrange and control within Bizzmine.

Also for the proposal and approval of improvement plans, Bizzmine seems to be very interesting. We designed a workflow that perfectly streamlines the requests for large projects, from requests for reviews of the different parties to the required tasks and notifications of what is happening in the project.

The benefits of Bizzmine in a nutshell

Fast and efficient

With a good preparation for the design of the forms and workflows, Bizzmine implemented the deviation, CAPA, and MoC application within two days. After the implementation, the Bizzmine team provided quick and efficient support.

Scalable across sites

After the site in Veenendaal, the branches in Switzerland, France, the UK, and China can also set up the same workflow modules within Bizzmine. We can do whatever we want in the flexible platform without having to deploy extra people.

Multilingual

Our users can choose the language they prefer. The fact that the software also recognises and supports Chinese characters is a nice bonus.

Jeroen de Jong - Risk and Compliance Manager

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the CARBOGEN AMCIS video testimonial. Watch and learn how Jeroen de Jong shares his experience with Bizzmine.