CENTRAL SERIALIZATION SYSTEM
Ksr
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KSR service is developed for serving the needs of Pharmaceutical Companies which have serialization needs based on EU/2011/62 (FMD). The smaller Pharmaceutical Companies (MAH) typically don't produce their product themselves at all or they have only a small packaging line with low production volume. They use CMO, who
produce and package the drugs for them.
The number of CMO used by an MAH and the produced drugs (prescription) typically less than 20.
For them, a more cost-effective decision instead of an expensive investment is to use a cloud-based service.
In return for a monthly subscription, they get a private cloud service with a secure infrastructure that allows them to fulfil their serial numbering obligations. The service includes the necessary functionality, integration links, and operation.
Furthermore, Syndicate operates a helpdesk system that provides continuous user support.
The KSR cloud service includes all of the operations that are defined as ISA L4/L5 functionalities:
• Generating serial numbers for packaging,
• Keeping connection within EU HUB according to EMVO,
• Reserving and maintaining serial numbers in a production database.
The users of the system are MAH and CMO organizations, which have their daily serialization tasks: the CMO marks with unique identifiers the packaging of the drugs while the KSR generates the serial numbers and reserve commissioned serial data and finally submit the serials to the EU HUB.
most important functionalities of the KSR system
THE BASIC KSR OPERATIONS
MAH registration
System access
Serial generation
serial download
Serial uploa
dChange of serial status
Serial submission to EU HUB
Maintain serials for 5 years
THE BASIC WORKFLOW
OF THE KSR SYSTEM OPERATIONS:
• The serial number is requested for the daily packaging operations (1.2): both MAH and CMO can ask for a given quantity of serial numbers
• The generated serials are stored in KSR will be downloaded as a file (3) by the CMO through SFTP
• After successful packaging/marking, CMO will reload the commissioned/shipped serials a to KSR (4) through SFTP
• The relevant serials will be submitted to the EU HUB (5) in the appropriate format
• KSR Database will reserve all commissioned serials for 5 years, and provide the necessary maintaining functionalities.