serialisation, aggregation, Track & Trace
10% of medicine in the global supply chain is counterfeit.
Compliance with regulations
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
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
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.
Site tracking and Level 4/ 5 integration
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.
Falsified medicines directive
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.
Why work with us?
Crest Solutions has been delivering the leading range of Antares Vision solutions to clients with sites of all shapes and sizes in Ireland, the UK, Benelux and Scandinavia since 2012.
- 1000s of lines serialised worldwide
- 500+ lines fully aggregated
- 150+ plants equipped worldwide
- 5 billion+ products serialised globally
- Crest Solutions engineers train on site in Italy with Antares Vision
- Our team is fully integrated with shared services and support model
- Our client comes first. We prioritise leading support and communication throughout each project.
- Training available to ensure your team is skilled in these technologies before we leave your site
Crest Solutions developed a customised solution that suited our business model. They ensured the work was fully compliant and validated with industry regulations such as software applications that facilitate compliance with 21 CFR Part 11 and QMS, in line with ISO 9001.2008. Their embedded engineers and customer service levels excelled our expectations.
I'd like to acknowledge the hard work being done by the Crest team on site here. The Crest Embedded Engineers have gone above and beyond to help us get Track and Trace projects over the line. Their training, skills and professionalism are second to none. I'd highly recommend Crest Solutions.
I would like to congratulate Jason on his work. He is highly skilled and confident at his job, great training from Crest Solutions. Not only was the line configured successfully, but also a few pre-existing issues were solved. He did a fantastic job and we couldn’t ask anything else from him. We were also delighted with the embedded engineers option provided by Crest.
I would like to thank the team from Crest Solutions for their dedication to customer service levels. Their team is always friendly and ready to provide assistance.
Crest's serialisation solutions are so innovative. They partner with other leading edge companies in serialisation such as Antares Vision. We were really impressed with their camera capabilities, you don't get better than Cognex in the pharma industry. They've helped us build intelligent supply chains with end to end traceability, saving us time and money.
The installation of our new Vision system started this morning and we were executing OQ/PQ validation by this afternoon. Such successful execution within this aggressive time frame would not have been possible without extensive planning completed offline by Crest Solutions. This gave us confidence that we would have no issues during installation which was very much the case.
Get in touch
Does your pharmaceutical packaging site need to comply with regulations for Serialisation, Aggregation and Track & Trace?