Drug Serial Number Management System
Ksr
Enquiry / DEMO
If you have any questions about the KSR product, please contact us at +36-1-487-3011.
The system has been developed for small pharmaceutical companies (SMEs) for which Dr 2016/161/EU imposes a numbering obligation.
The KSR is a cloud based solution and it can be used for subscription fee. After a short registration process the service is ready to use. No risk, no investment from the customer side.
KSR
Drug Serial Number Management System
CENTRAL SERIAL NUMBER MANAGEMENT SYSTEM
KSR BASIC FUNCTIONS
MAH Registration
Serial Number Generation
Serial Number Download
Serial number upload
Batch data change
Serial number reporting to EU-HUB
Serial Number maintenance for 5 years
The KSR system is available in a so called private cloud configuration and covers to the following needs:
Generates FMD compliant serial numbers for secondary packaging of medicinal products.
EMVO maintains a relationship with the EU HUB as specification.
Ensures that the prescribed serial numbers are kept and maintained at a time.
The system users are the employees of MAH and CMO organizations with daily numbering requirements: the CMO writes the serial numbers specified by the MAH on the boxes, while the MAH generates them and send them to the production database or to the EU HUB in accordance with FMD specifications.
