Serialisation - Implementing falsified medicine legislation
Serialization became be mandatory in February 2019.
We provide qualified, independent consulting and hands-on support in initiation, update and implementing corresponding processes in your QM system - based on your internal processes, current requirements and your products.
- Professional review of your entrepreneurial- and QM situation
- Hands-on partner for on-boarding
- Advice and support in the selection of suitable serialization software reflecting your needs
- Creation and / or updating of your SOPs, e.g. market release, release for sale, verification, complaints or recalls
- Implementation and training of processes according to the organizational requirements
- Partner in uploading or de-registration of serial numbers on your behalf
- Supplier qualification
- Implementation of projects to improve the QM system and GxP processes
- Monitoring compliance
Please feel free to contact us.
We are looking forward to give you all the strategic and operational support you require.