"Carbogen Amcis selected Vivaldi Software to be compliant to ISO, FDA, GMP."

- Jeroen de Jong , Manager QHSE

The production and it’s facilities need to comply to high standards from legislation on pharmaceuticals productions. Within the quality system CAPA-management (corrective action and preventive action), Complaints and Management of Change (MoC) are important processes that have to fulfill to GMP, ISO and FDA requirements.

These processes have been executed in a paper-based system. With the workflow module from Vivaldi the CAPA and MoC processes have been made ‘paperless’ and is compliant to the requirements of 21 CFR Part 11 (Electronic Records; Electronic Signatures).

It has been proved that both the software and the customized applications are able to be qualified for use in a pharmaceuticals environment. With a good preparation on the design of the forms and workflows, Vivaldi was able to implement both CAPA and MoC application within two days.

The necessary but limited need of support after the Implementation responded to quickly and excellent by Vivaldi. The workflow module has reduced the workload and risks on important regulatory aspects.

Jeroen de Jong, Manager QHSE
www.carbogen-amcis.com