How Galenica uses Bizzmine quality management software to automate CAPA, deviations and audits while simplifying system validation.
Galenica supports pharmaceutical development and manufacturing under strict regulatory requirements. As the organisation expanded its operations, manual workflows made it difficult to manage quality processes efficiently. Galenica implemented Bizzmine quality management software to digitise workflows and support structured management of CAPA, deviations, complaints and audits. The platform now provides a flexible environment for managing validated quality processes while supporting operational efficiency.
This case study explains how Galenica uses Bizzmine quality management software to:
digitise quality management workflows
manage CAPA, deviations and change control
simplify validation of quality management processes
configure workflows without heavy IT dependency
support compliance with pharmaceutical regulations
Galenica is a pharmaceutical technology partner that supports organisations in pharmaceutical development and production. The company specialises in pharmaceutical and analytical development as well as the production of Clinical Trial Material for phases I through III. Galenica also produces niche pharmaceutical products for commercial markets and operates under strict European pharmaceutical regulations monitored by the Swedish Medical Products Agency.
As Galenica continued to grow, the organisation decided in 2021 to digitise and automate its internal workflows to increase operational efficiency.
Managing quality processes such as CAPA, deviations and complaints through manual systems required significant effort and limited visibility into workflow progress.
The organisation therefore evaluated digital solutions and selected Bizzmine as the most suitable platform to support its defined quality processes. The decision was influenced by the flexibility, scalability and user friendly configuration of the system.
Galenica implemented Bizzmine to digitise and automate key quality management workflows.
The organisation developed a business case by analysing the time and costs associated with several quality processes that could benefit from digital workflows. Based on this analysis, the first phase focused on implementing workflows for Actions and CAPA, Change Control, Deviations, Complaints and Audits.
After these processes were successfully implemented and validated, Galenica continued expanding the platform by rolling out document management.
To support further adoption, internal users were trained to configure additional workflows. Training materials and documentation from the Bizzmine support portal helped employees learn how to configure the system independently.
Bizzmine enabled Galenica to formalise the validation documentation required for the system.
The organisation documented approximately 300 validation requirements related to application functionality. Because most requirements correspond to standard platform functionality, validation efforts could focus primarily on critical configurations and a limited number of custom adjustments.
This approach significantly reduced the internal effort required for system validation while maintaining compliance with pharmaceutical regulatory expectations.
Key results after implementing Bizzmine
Approximately 300 validation requirements documented in the system
Centralised management of CAPA, deviations, complaints and audits
Digital workflows implemented for core quality processes
Internal teams trained to configure workflows independently
Reduced validation effort for system functionality
“Automated business processes can probably never have been easier to create and validate.”
The transformation began with the strategic decision to digitise quality management workflows to improve efficiency.
Galenica then built a business case identifying the quality processes that would benefit most from digital workflows. The first implementation phase focused on CAPA, Change Control, Deviations, Complaints and Audit management.
After these processes were successfully validated, the organisation continued expanding the system with document management and additional workflows configured by trained internal users.
Pharmaceutical organisations operate under strict regulatory frameworks where validation, documentation and traceability are essential. Managing quality processes through manual systems limits efficiency and increases validation effort.
Digital quality management software enables pharmaceutical organisations to structure workflows, simplify validation activities and maintain compliance while improving operational efficiency.
Quality management software is a digital platform used to manage processes such as document control, CAPA management, audits and regulatory compliance workflows.
Validation ensures that digital systems used in regulated environments function correctly and comply with regulatory requirements.
CAPA software helps organisations document corrective and preventive actions, assign responsibilities and track resolution of quality issues.
Organisations implement digital quality management platforms that allow workflows such as deviations, complaints and audits to be automated and tracked centrally.
Quality management software is widely used in pharmaceutical manufacturing, biotechnology, medical devices, logistics and other regulated industries.
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