Industry: Pharmaceuticals
The aim of the project was to replace paper labels on medication packaging with a digital version (e-label) with components that are connected via the Internet. This saves manual effort and automates documentation.
The e-labeling software developed is a web-based application for remote data updating of e-labels for the pharmaceutical industry using RFID labeling.
All work was carried out in accordance with the regulatory requirements for medical technology and pharmaceuticals. The following standards were applied: ISO 13485 (quality management systems for medical devices), ISO 14971 (risk management for medical devices), IEC 62304 (medical device software – software life cycle processes) and ISPE GAMP 5 (Good Automated Manufacturing Practice).
The development of the e-label solution was based on agile working according to Scrum and Kanban in three-week sprints. The sepp.med Scrum team consisted of five employees.
sepp.med defines a suitable and standards-compliant software development process within the scope of the project, from requirements definition to software/hardware integration. In addition, it is possible to create a review-proof database with an audit trail on a web server, implement a rights system, and set up a workflow-supported approval process.
In the project, you also benefit from the fact that sepp.med only employs personnel who are certified according to ISTQB® or CPMS® Certified Professional for Medical Software.
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