LOOKING FOR A TRACK AND TRACE SOLUTION?

We have developed specific packages covering Medical device (UDI) Pharma manufacture's, Wholesalers and Importers who are needing to meet the new FMD regulations

LOOKING FOR A TRACK AND TRACE SOLUTION?

We have developed specific packages covering Medical device (UDI) Pharma manufacture's, Wholesalers and Importers who are needing to meet the new FMD regulations

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Track & Trace

The core of the system is based on a modular software architecture.

This approach ensures that the software can be adapted at any stage to changing requirements at reasonable costs: for instance if you wish to incorporate additional lines and sites in the management system, if you need to adjust your processes to new coding and aggregation regulations or if you are investing in additional machinery. Within certain limits, our solution also caters for machines from other manufacturers.

The software solution can be implemented as a powerful production management platform for the simultaneous control and management of a wide range of coding and aggregation hardware.

Not only the formats, recipes and programmes of the b+b hardware components are automatically sent to the production line: the systems of other manufacturers are also parameterised for fast product change-over.

Please note that, due to the modular software architecture, the modules and add-ons presented here only represent a selection of those possible. Special modules or module add-ons to existing solutions, including subsequent validation, are possible at all times.

Reliable serialisation and labelling systems are to do away with the trade with illegal pharmaceuticals, chemicals and medical devices for the food, medical technology and the pharmaceuticals industry at global level for ever. By means of the latest EU directives passed, the European Union has launched its initiative against product counterfeiting.

The basic prerequisite for the counterfeit protection of a product is the unique allocation of a serial number combined with individual production data (product identification GTIN/NTIN/PPN, use-by date and batch number) in the form of a Data Matrix Code. Combined with the seal labels on the end of folding boxes, this unique “labelling” protects against manipulation of the authenticity and the undamaged nature of a product. It is the key to its flawless traceability and the basis for the consumer’s complete trust in the producer.

  • Site Server Module
  • The b+b SiteServer is the central database and service application, and represents the control centre of the entire software modules.
  • Pharmaceutical importers - Serialisation startup package
  • Together with our partners, an global PI experienced pharma consultancy and working closely with many PI companies, we have developed an unrivalled understanding of the regulations and their interpretation in the PI context making us your ideal partner to choose
  • Pharmaceutical Wholesaler - Serialisation startup package
  • The serialisation of drug packaging becoming mandatory from February 2019 as a key component of the EU-FMD requirements, presents a major challenge to Pharmaceutical Wholesalers in regards of identifying a suitable software and hardware combination and choosing the right partner to get support from in the serialisation journey.

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