Audits in the pharmaceutical sector are a regulated and complex process. It involves a lot of administrative effort and a lot of coordination. This is mainly due to the triangular relationship between the pharmaceutical company, suppliers and audit service providers.
The pharmaceutical company (our customer gempex) ensures that the supplier's production meets all quality standards. The supplier (audit) supplies the pharmaceutical company and must meet those quality standards. gempex, as an audit service provider (auditor), is commissioned by the pharmaceutical company to carry out an audit. This ensures that the supplier adheres to the quality standards.
There is currently a lot of process knowledge in the minds of the employees at gempex. The documentation of various process steps and the storage of the relevant documents takes place in different locations:
• Email to communicate relevant information
• Excel files for documenting process steps
• SharePoint for document storage of individual steps
What gempex needed was a tool to reduce the coordination effort. It should also ensure more process transparency. In collaboration with SIDESTREAM, the audit tool was created - a central application to digitize the audit process end-to-end. On the one hand, the goal is to achieve efficient process design internally using the tool; on the other hand, it should also offer pharmaceutical companies and suppliers more transparency and better coordination.