How CARBOGEN AMCIS replaced paper based quality processes with a digital QHSE software platform to improve compliance and traceability.
CARBOGEN AMCIS manufactures cholesterol and vitamin D products for pharmaceutical, cosmetic and feed markets. Operating under strict FDA, GMP and ISO requirements requires full traceability and control of quality processes. Paper based documentation made it difficult to track forms and maintain oversight across the organisation. CARBOGEN AMCIS implemented Bizzmine as its digital QHSE software platform to manage deviations, CAPA and change management in one structured system that improves transparency, compliance and operational control.
This case study explains how CARBOGEN AMCIS uses Bizzmine QHSE software to:
replace paper based quality processes
manage deviations, CAPA and change management digitally
create traceability and compliance for GMP regulated processes
implement workflows quickly and efficiently
scale compliance processes across multiple sites
CARBOGEN AMCIS manufactures cholesterol and vitamin D products used in pharmaceutical, cosmetic and feed markets. Production ranges from laboratory scale batches to large industrial production volumes.
Jeroen de Jong, Risk and Compliance Manager at CARBOGEN AMCIS: “I manage risk and compliance at CARBOGEN AMCIS and I was responsible for the implementation of Bizzmine at our site.”
Operating within highly regulated pharmaceutical environments requires strict control of quality documentation and operational processes. “Our operations run under regulatory frameworks such as FDA, GMP and ISO. That means we must maintain full control and traceability of quality processes.”
Before implementing a digital QHSE platform, CARBOGEN AMCIS relied on paper documentation to manage quality processes. “Until the implementation of Bizzmine we worked with a paper based system for our quality processes.”
This created operational risks and limited visibility across the organisation. “The disadvantage of paper is that documents can be everywhere. It becomes difficult to track all the forms moving through the organisation.”
In highly regulated environments, this lack of visibility creates compliance challenges. “That situation is not acceptable in an environment operating under FDA, GMP and ISO requirements. We needed better control of our documentation.”
The organisation therefore decided to implement a digital quality management system. “To gain more control of documents and processes we decided to implement an electronic system such as Bizzmine.”
CARBOGEN AMCIS selected Bizzmine as its digital QHSE software platform because of its flexibility and ability to adapt to organisational workflows. “One of the main reasons we chose Bizzmine was the flexibility of the software. You can create your own workflows so the system adapts to your processes.”
The platform introduced structured digital workflows for key quality processes. “The first processes we implemented were the core quality workflows such as deviation management, CAPA and change management.”
Bizzmine also allowed the organisation to digitise additional operational processes beyond quality management. “The system is also used for other processes such as capital expenditure requests. We also created a process called Plan Tracker where employees can submit project proposals.”
These workflows provide visibility into ongoing projects and resource planning. “With that process we can see which projects are running and what the impact is on resources and budgets.”
The implementation of Bizzmine significantly improved transparency and traceability across quality processes. “For us Bizzmine provides transparency, compliance and traceability of our quality registrations.”
The system also allows rapid implementation of new workflows. “When you prepare your workflows and forms properly, it is possible to implement a process within four or five days.”
The platform supports scaling processes across sites and teams. “After implementing Bizzmine at our site in Veenendaal we were able to roll out workflows to other locations as well.”
Multilingual capabilities support international operations. “We created forms in multiple languages so employees at different sites can work in their own language.”
Key results after implementing Bizzmine
Paper based quality processes replaced by digital workflows
Centralised deviation, CAPA and change management processes
Implementation of new workflows in a few days
Scalable QHSE platform across multiple sites
Multilingual forms supporting international teams
“Bizzmine adapts to our processes instead of forcing us to change the way we work. It gives us transparency, compliance and full traceability of our quality registrations.”
CARBOGEN AMCIS approached the digital transformation in several phases to ensure that the platform aligned with operational processes. “The first step was analysing our quality workflows and translating them into digital processes.”
The platform was then configured to support deviation management, CAPA and change control processes. “Once the first workflows were implemented we could gradually expand the system with additional processes.”
The organisation also scaled the platform across sites and teams. “Because the platform is scalable we were able to roll out workflows to other sites while maintaining site specific dashboards and workspaces.”
Many pharmaceutical manufacturers still rely on paper documentation to manage quality processes. As regulatory requirements increase, these systems become difficult to control.
Jeroen de Jong: “A digital QHSE platform allows us to manage quality processes with much greater transparency and compliance.”
QHSE software is a digital platform that helps organisations manage quality, health, safety and environmental processes within one central system.
Digital quality management improves traceability of processes, reduces manual administration and ensures that compliance activities are recorded and followed up consistently.
CAPA management software ensures that corrective and preventive actions are documented, assigned and tracked until completion. This helps organisations resolve quality issues and prevent recurrence.
Pharmaceutical companies use quality management software to manage deviations, CAPA processes, change management and documentation while maintaining full traceability for regulatory inspections.
Industries with strict regulatory requirements such as pharmaceuticals, chemicals, logistics and manufacturing use QHSE software to manage compliance and operational processes.
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