Central Serial Number Management System

drug line numbering

Ksr

CENTRAL SERIALISATION SYSTEM 1

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 EU/2011/62 (FMD) requires a numbering obligation. 

The KSR system is possible for a monthly fee. After proper registration, users will receive the user/password combination required to operate the system, which allows them to log in and use the system using a normal browser.

Ksr

CENTRAL SERIAL NUMBER MANAGEMENT SYSTEM

KSR BASIC FUNCTIONS

MAH Registration
System Usage Serial
Number Generation Ser
ial Number Download

Serial number uplo
ad Batch data change seria
l number reporting to EU-HUB Serial
Number maintenance for 5 years

The KSR system is available in a so-called private-cloud configuration and caters 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 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 a u.n. production database or to the EU HUB in accordance with FMD specifications.