Audit Management CAPA Management Complaint Management Document Control Pharma

Galenica AB supports and guides our partners in their pharmaceutical development programs. We are experts at pharmaceutical and analytical development and production of Clinical Trial Material (CTM) for Phase I – III. Galenica AB also manufactures commercially niched products for the market. We need to comply with the pharmaceutical regulations of the European Union and are authorized and audited by the Swedish Medical Product Agency.

Creating and validating automated business processes have probably never been easier.

Being a growing and expanding company, a strategic decision was made in early 2021 to digitalize and automate business workflows to achieve higher efficiency compared to the existing, mostly paper-based, organization.

From an efficiency perspective, it was natural to begin looking at the cross-functional quality management processes where probably the highest benefit of digitalization could be achieved.

We established our business case by thoroughly looking at the time and cost a digitalized workflow most likely would save us for a number of quality processes and decided to move forward with Actions/CAPA, Change Control, Deviations, Complaints, and Audits.

BizzMine was at the end selected as the most suitable application to support the identified processes mostly because of its high flexibility, scalability, and very user-friendly configuration and maintenance. We can easily create and optimize all the workflows we need in-house, with no or minor external support. An additional success factor was that BizzMine also included a Document Management module.

After successfully having implemented and validating the management of Actions/CAPA, Change Control, Deviations, Complaints, and Audits we now move forward with implementing Document Management. We have also trained dedicated users who are now driving the implementation of additional workflows per the needs of the organization. The challenge in this effort has not been to train people in configuring BizzMine. This has been easy with the help of the supporting videos and articles in the BizzMine Support Portal. Rather the challenge, in this case, has been to get the organization familiar with the concepts of optimizing processes and the BPM methodology.

It has been very valuable that BizzMine provides a formalized Validation Documentation Pack with respect to the application’s standard and core functionalities. In our User Requirement Specification, we have about 300 requirements. Almost all of them ended up being standard functionality, i.e. we have been able to leverage and limit our internal Computer System Validation efforts to a great extent with the Validation Pack, focusing only on highly critical configurations and the very few customizations we have put in place.

The system is built in such a way that you can create and implement workflows that are segregated from a system perspective. This allows us to validate each new workflow separately with no or only minor impact on the current solution, i.e. there is basically no need for regression testing.

As for BizzMine support, I could not be more satisfied. We get a response very quickly and there is never an issue that is not fixed within a reasonable amount of time. The improvements we would like to see are in most of the cases already in the pipeline.


Nicklas Helgesson, Sr QA Specialist & Implementation Project Lead