Serialization and Treacebility solution
for all requirements in Lifescience.

CureSync is enterprise level, flexible, easily integrated, high quality solution that is responding to the needs of all parties in pharmaceutical supply chain and to all known regulatory requirements accordingly.

Creative, adaptive and ever-ready solutions.

CureSync was written on pharmaceutical context having in mind full data integrity (including last MHRA, FDA and EMEA guidelines) as well as GAMP5 postulates.

Serialization System 2.0...

...is built after a careful analysis of clients’ perspectives about the real-life challenges and requirements regarding the implementation of a serialization system, Track and Trace and managing serialized items. CureSync covers L2-L5 levels of pharmaceutical serialization.

CureSync overview

The CureSync Serialization System 2.0 is built after a careful analysis of clients’ perspectives about the real-life challenges and requirements regarding the implementation of a serialization system, Track and Trace and managing serialized items.

Guiding principles

In order to satisfy the demands from different clients, from extremely small with simple production, via distribution and logistics channels, to extremely complex, multinational organizations operating in multiple countries with diverse regulatory requirements.

After gathering experiences and needs, the following guiding principles are incorporated into version 2.0 of the CureSync Solution: 

  • Hardware and Software platform independence 
  • Modular design based on Open Standards and SOA principles 
  • Highest possible horizontal and vertical scalability 
  • Flexible delivery models to suit the most demanding needs 
  • Multipurpose usage within the integrated platform 
  • Ability to model business processes easily and adapt to any client needs 
  • Superior integration capability 
  • Configurability, to minimize customization at the programming level 
  • Adhering to Cloud principles, in terms of multi-instance, multitenant and SaaS concepts 
  • Reliability, in terms of uptime and resistance to unplanned interruptions, including disasters

Multipurpose usage within integrated platform

While CureSync comes as integrated platforms, it allows different configurations aligned with specific organizational needs. Modelling of the CureSync environment is a process where decisions are made about how many instances and tenants will be used to support the specific or projected level of organizational complexity.

Based on the organizational requirements CureSync is thus configured to serve as: 

  • Global Serialization System 
  • Site serialization manager 
  • Floor serialization Manager 
  • Line serialization manager, where each of those configurations can be a part of a unique instance of CureSync, a separate instance of CureSync or a tenant inside a multitenanted CureSync instance.

System architecture

To ensure the highest possible flexibility, this system is built on Open Standards and SOA Principles. This means that the components embedded into the solution can easily be adapted or changed over time, to keep the system at the leading edge of technology for the long term.

CureSync is a typical multi-tier application, which is represented by Figure …

Application architecture
CureSync Application Architecture

Most commonly, a web browser is used, which enables portability, including mobile devices, and ensures easier operation, especially for the production environment.  

Web services are exposed in order to communicate with external systems, and utilize CureSync functions. 

EPCIS, as a special component is designed to: 

  • Be integrated as part of CureSync, which is the optimal configuration 
  • Be a separate part of the solution, but still manufactured by TradeTicity and accessed through CureSync, typical for a complex organization who wishes to use only one EPCIS repository, using other CureSync instances to access the external CureSync repository 
  • Be a 3rd party component, if required. 

Logical Architecture of the System 

The logical perspective of the system is shown in Figure…

Application architecture
CureSync Logical Architecture

Functional modules

CureSync functional modules are represented in Figure…

Application architecture
CureSync Functional Model

Depending on the usage of CureSync, some or all components may be active. For example, having a site utilizing numbers from some other repository, whether CureSync or not, will eliminate the need for the Serial manager. However, if the need arises for a site to request production from a third party, CureSync will retrieve the serial numbers from an external system, and use Serial trader to provide the serial numbers to the third party when needed

Ability to model business processes easily and adaptable to client needs

As different clients and industries (e.g. Pharmaceuticals vs. Wholesalers) use different processes, the system has an adapted Business process server, which we call 'Serialization Orchestration'

CureSync Process Model

This component allows administrators to use either a graphical user interface or development tools, such as ECLIPSE, to model business processes or adapt existing ones according to business requirements. The system comes with many pre-implemented processes, however during the final configuration such details as how to handle printer events or system messages, external EPCIS messages, etc, will  be automated to client specifics.

Integration capability

The CureSync has an adapted Integration layer, able to handle all necessary communication, easily transform and transfer messages between different standards and protocols. This functionality gives a unique advantage, especially for change management, or when it is necessary to agree communication vocabulary between partners and stakeholders.

The major task of serialization system is to communicate with external IT systems, different and diverse equipment, national agency systems and repositories; external partners such as MAHs or CMO's, distributors, etc. therefore, CureSync has an adapted Integration layer, able to handle all necessary communication, easily transform and transfer messages between different standards and protocols. This functionality gives a unique advantage, especially for change management, or when it is necessary to agree communication vocabulary between partners and stakeholders. It is this integration layer that enables CureSync to connect to various sources and end points seamlessly, without fear of losing messages or transactions. With embedded message queuing, this represents the ideal solution for integration with production line equipment, using either XML-like schemas, or even drivers.

CureSync Integration

Configurable, to minimize customization at the programming level

Often, a simple change in serialization will difficult, e.g. changing the structure of serial numbers from numeric to alphanumeric, or adopting new label structure due to changes in regulation.

CureSync however, adopts the principle of templating, where it is possible to define vocabularies for almost all entities in CureSync: 

  • Products 
  • Partners (CMOs, MAHs, 3PLs, Distributors, Wholesalers, etc.) 
  • Organizational units 
  • Users of the system 
  • External users (patients) 
  • EPCIS 

Those vocabularies contain attributes of specific types, such as custom defined enumerations (including countries, Business steps, Transportation types, etc.) 

Using this approach, CureSync is easily customized to serve different market needs, and is easily adapted for any future change.

CureSync Templating

Solutions

  • CMO's

    Can you continue your work without serialization solution? Since majority of MAH companies are outsourcing manufacturing to CMO’s you are...

    Read More ...

  • Generic and Originator Pharma

    Can I have 5 different solutions for 5 different markets? Most commonly manufacturers are operating on international market and their...

    Read More ...

  • Marketing Authorization Holder

    What are MAH obligation in regards to Serialization? MAHs are, from perspective of regulatory bodies, only legally recognized entities...

    Read More ...

  • Serialization

    Serialization is applying a traceable serial number to a smallest selling item. A serial number must be assigned to each selling item as...

    Read More ...

  • Supply Chain

    Wholesalers in the whole world are obliged to adapt to different regulations and directives, for example EU FMD – Falsified medicines...

    Read More ...

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