CARBOGEN AMCIS
Our production and its facilities need to meet the high standards of pharmaceutical production legislation. Within the quality system, Deviation Management, CAPA Management (corrective action and preventive action), Management of Complaints, and Management of Change (MoC) are important processes that have to comply with cGMP, ISO, and FDA requirements. In the past, these processes were managed in a paper-based system. The BizzMine workflow module has made the CAPA and MoC processes ‘paperless’ and compliant with the requirements of 21 CFR Part 11 (Electronic Records; Electronic Signatures).
The validated BizzMine platform and our user-specific applications within the software can perfectly be used in a pharmaceutical environment.
With 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.
The workflow module has reduced our workload and risks on important regulatory aspects.
It has now been 3 years since we migrated from Vivaldi 5.0 Process to Flow to BizzMine. We are very happy with this transition since we can also use the new 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 our Technical Project Review, 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 look and feel of the software is very nice for the end user.
At the moment, we are preparing the implementation of BizzMine within CARBOGEN AMCIS Corporate. After the site in Veenendaal, the branches in Switzerland, France, the UK, and China will also set up the same workflow modules within BizzMine. We are positive about this challenge because you can do whatever you want in the flexible platform without having to deploy extra people. The fact that the software also recognizes and supports Chinese characters is a nice bonus.
Jeroen de Jong, Manager QHSE
www.carbogen-amcis.com
