Galderma’s site in Uppsala, Sweden (previously Q-Med) is the company’s Global Aesthetic Center of Excellence with nearly 450 employees carrying out world-class research and manufacturing.
A key aspect of compliance when manufacturing medical devices is monitoring the production environment – temperature, humidity and air pressure, etc.
The company was operating independent facility monitoring systems (FMS) for each production unit, which was time consuming and complicated. Data needed collecting from each unit and compiling manually.
The company had built a new clean room production unit and wanted an expandable and future-proof FMS solution that could boost efficiency and eliminate information islands.
PlantVision helped to develop, implement and optimize an integrated solution combining process automation, information management and quality assurance.
- The fully automated solution logs GxP data from sensor readings, including high and low value alarms. It handles approx. 2,000 measurement points across different production lines, plants and buildings.
- It includes a process data overview system for the presentation, reporting and long-term archiving of critical GxP data.
- All data is stored centrally. A web-based interface means all users can access the information from their own PC.
- Development and implementation was carried out under PlantVision’s stringent quality management system helping to ensure a smooth validation process.
- Significant time savings as users can now monitor all production units in real time from their own PC.
- Operators, process engineers, quality assurance and technical services all access and share the same real-time information.
- Automated and ad hoc reports can be quickly and easily generated making review and approval processes more efficient.
- The standardized approach simplifies administration and upgrading.
- The system facilitates regulatory inspections as the same underlying platform is used for all production units.
- Provides an expandable platform capable of incorporating new and existing production units.
“Users can view the entire system in real time from their own office. It saves an enormous amount of time since they no longer need to physically visit each production area to retrieve data.”
“This is a long term initiative. It was essential that the solution be based on a reliable supplier and stable products. We now have an expandable platform capable of incorporating both new and existing production units. And the more it expands the more its value increases.”
Dan Seidegård, Galderma