Entire Supply Chain Management

in one solution

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Flexible, secure and with quality at its heart

The biggest challenge facing pharmaceutical companies today is the compliance with 2011/62/EU and 2016/161 whilst other countries and regions issue their own legislation for serialization. There may be many production facilities, CMOs and geographical markets involved.

How will you be ready with a system capable of adapting to regulatory changes, which can interface with all of your existing business systems, line management systems, etc.? To do this on one site, compliant with GAMP5 is hard enough, but maybe there are many product types, over several sites, different IT systems, hardware.

The best way to do this would use open standards, to ensure flexibility and templates to ensure easy reconfiguration for new products or markets (and their regulatory requirements). This has to be done using a system that has Quality at its Heart.

A CureSync designed on Quality Compliance principles, applying expert knowledge of serialization, and realized in a modular format, using standard communication protocols for reliability.

The delivery of our solution can be Cloud, Hardware (with the option of secure Cloud back-up for quick disaster-recovery) or even self-hosted.

For the fastest possible deployment, with minimised disruption to your operations, we will spend time with you to fully understand your needs, and create your perfect integration, whether you have sites in many countries, are a single site, or a wholesaler requiring to be serialized.

CURESYNC – TOTAL SOLUTION

figure2-enCureSync is an enterprise level solution, designed for extreme workloads, and to support all of your most complex organization and processes associated with serialization. It is platform agnostic, which means that you can operate it on almost any hardware and operating system, use the database preferred by your IT department, and use any Java EE7 compliant application server.

CureSync is scalable from an extremely small Cloud-based application, to being a disaster resistant installation running multiple instances and hundreds of tenants within your organization

Depending of your role within the supply chain, CureSync comes predefined for:

  • Pharmaceutical manufacturers, with all print and verification standards, (including GS1); EPCIS business vocabulary; GDSN aligned product catalogue, etc.
  • Market authorization holder system, a simpler option for those without a self-operated manufacturing site
  • Contract manufacturing organization system with serial number import/export and automation, logistic features and EPCIS support
  • Supply Chain system designed for distributors, third party logistics or wholesalers with a feature set specific for those clients’ needs.

WE ARE QUALITY

Everything you do is built on quality, and that is how we built CureSync. CureSync is built in accordance to GAMP5 and it supports your validation. For example, CureSync allows you to make changes to the serialization format when your business or regulatory needs change, and it can be done with minimum revalidation. Make your required modification in CureSync and trigger the Quality Process to obtain all necessary quality approvals, before the change will become live in the system.

Our advanced Audit Trail makes it possible to examine all serialization events with one click on any screen in the system.

Everything is built around Quality, all compliant with GAMP5 and MHRA GMP Data Integrity Definitions and Guidance for Industry (January 2015)

FINDING THE PERFECT FIT

Having the flexibility to grow your business and the confidence to move into additional markets is key. Depending on the size of your company, budget and internal policies will affect how you may choose to implement CureSync.

The delivery of our solution can be Cloud, Hardware (with the option of secure Cloud back-up for quick disaster-recovery) or even self-hosted, using license from TradeTicity. Of course, all of these delivery models offer the same high standards of compliance and security, and can be connected to any print and verification devices.