Development of a GMP-compliant software application for production data analysis
Our customer, a leading British pharmaceutical company, commissioned the development of a software application for recording and analysing production data. The implementation was carried out under strict GMP requirements in order to guarantee the quality and safety of the pharmaceutical processes.
The project in a nutshell
Task
Creation of a software application for recording selected OEE data from the production environment • Compliance with GMP requirements in the pharmaceutical environment • Creation of GMP documentation
Realisation
Basis: Aveva System Platform incl. Aveva Historian • Connection of approx. 70 production control systems • Creation of a standardised interface configuration for automatic import of the relevant data • Implementation under GMP/GAMP requirements
Added value
Quality-relevant data is available alongside technical and energy data for evaluating the production processes • Extensive data analyses are possible (e.g. proof of quality, predictive analytics) • Compliance with GMP requirements, extensive documentation and test scenarios have been created
"In addition to the task of solving the technical requirements, the provision of the qualification documents (test documents, specifications, methodology) was very challenging. Especially as the data had to be acquired in real time. With a small team from different locations, the implementation worked very well!"
Gernot Heinrich
Head of Region Engineering Solutions Nordost