In pharmaceutical production, an effective batch reporting process is essential for efficient product release.
At our customer’s site, the templates used for batch reporting were located on a system that had not be updated and was not being actively supported. Any system problems risked significant production disruption and increased operational costs.
There was a clear and immediate need to migrate the batch report templates to a supported system. Intensifying the challenge was the fact that the two systems were incompatible. The migration project also needed carrying out without affecting ongoing production, and meet all regulatory and quality requirements.
Effective project management was crucial to the project’s success. Mapping the scope of the project, identifying key factors early on, creating well-defined roles and a dynamic project-team culture, and clear communication with all stakeholders helped to ensure smooth progress throughout.
An agile approach was taken to allow prioritization based on necessity and business value. This enabled greater focus and also meant obstacles and challenges could be dealt with at an early stage.
Results achieved included:
- All templates migrated successfully according to time plan.
- Reduced organization stress, as agile approach made it possible to scale activities up or down depending on time pressure, complexity and capacity utilization.
- No quality deviations reported during or after project implementation.
- Improved administration capabilities for batch report templates.
- New solution enables simpler life cycle management of future amendments and additions – representing a huge potential cost saving.