serialisation, aggregation, Track & Trace

We support pharmaceutical clients to achieve compliance with regulations for Track & Trace including the Falsified Medicines Directive. Crest Solutions is the exclusive partner integrator for Antares Vision solutions for serialisation, aggregation and Track & Trace. We integrate and support these modular systems in pharmaceutical packaging sites in Ireland, the UK, Benelux and Scandinavia.

Serialisation is the assignment and application of a serial number to any individual item to be sold to a consumer. This product identifier is recorded on the outer packaging, typically the carton or bottle, and it must be unique and verifiable.

Aggregation means building the parent-child relationship as products move through the supply chain. At each packaging stage information is collected, parent codes are assigned and data is recorded as required by relevant market regulations.

Antares Vision deliver a range of software solutions to facilitate site tracking and communication of data across sites and with the external repository. The Global Tracking System (GTS) is at the heart of the Track &Trace system. Running on a remote server, its main function is to allocate work orders issued by the ERP to production lines. After production has begun, GTS receives in real time the production data from all lines, as well as statistics, serialised codes and audit trails and stores them in the Site Database, where they are accessible to the plant ERP. 

The access to GTS is managed through the security levels required by for compliance with 21 CFR part 11, therefore only authorised operators can access production functions.

By the deadline of 9th February 2019, all manufacturers supplying pharmaceutical products to European countries will have to comply with the requirements set out in the Falsified Medicines Directive 2011/62/EU.