Context
The management of veterinary medicinal products and medicated feed is governed by European regulations, which have been subject to amendments.
The UPD / NVR project aimed to bring ANMV's IT tools into compliance with these new regulations, while ensuring the continuity of ongoing processes.
Our Intervention
Oceane Consulting Data Management intervened on a fixed-price basis to adapt the system and processes to the new regulation.
- Preparation of data, applications and processes to enable the export of Legacy Data to the European Medicines Agency.
- Modification of existing processes to ensure compliance with Legacy Data and other changes to medicinal product information.
- Duplication of certain processes so that ongoing processes remain compliant with the previous regulation and new ones comply with the new regulation.
- Modification of document templates generated by the tool.
- Completion of outstanding tasks.
Technologies used: Workey (BPM), Oracle, Java, J2EE.
Results
- Adaptation of various reference systems and existing processes to ensure compliance with the new regulation.
- Implementation of a transversal screen (iframe) allowing medicinal product information to be modified directly from Workey, without going through a third-party application.
- Locking of write access to medicinal product data to prevent concurrent access.
- Completion of existing medicinal product data.
- Update of document templates and PDF export of the Summary of Product Characteristics (SPC).
- Project still ongoing.