With ATSFOUR, Antares offers an innovative software solution for archiving and exchanging generated data for the serialisation of products in the pharmaceutical industry.
11. October 2018
With the intuitive ATSFOUR software solution from Antares Vision, data exchange in connection with the serialisation of products is child's play. (Image: Antares Vision)
The serialisation of products is coming, that much is certain. Data exchange in this context is no easy task: Italian track & trace and serialisation specialist Antares Vision offers the new powerful software solution ATSFOUR, which can manage large volumes of data thanks to an innovative storage system, as a solution to precisely these problems.
ATSFOUR enables the exchange of traceability data both with the production sites and with the entire supply chain network. And all this even when different interfaces need to be operated. The German company was one of the first to Generics specialist Biomo Pharma GmbH headquartered in Hennef, Germany, decided in favour of the holistic solution from Antares Vision.
Emidio Zorzella, CEO of Antares Vision. (Image: Antares Vision)
„We are very proud of ATSFOUR,“ emphasises Emidio Zorzella, CEO of Antares Vision. „It is software that is precisely tailored to the needs of pharmaceutical companies.“
Who is responsible for serialisation?
The serialisation obligation is not only incumbent on the pharmaceutical manufacturers themselves, but also on brand rights holders, for example. Biomo is one such MAH that does not manufacture medicinal products itself, but rather repackages them and has opted to serialise them as a so-called „Distributor“ not to outsource serialisation, for example to contract manufacturers, but to implement it ourselves.
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Another reason in favour of the In-house serialisation The internal make-or-buy analysis carried out by the authorisation holder Biomo speaks in favour of the new regulations. The family-owned company wants to comply with the new EU regulations as quickly as possible in order to fulfil the new requirements on the one hand and not face any unexpected problems in February 2019 on the other.
The EU Pharmaceuticals Directive EU/2011/62 (EU-FMD) is at least partly new territory for pharmaceutical companies, and new systems always require a certain start-up process. This is why Biomo is currently implementing ATSFOUR. The plan is to enter the test phase as soon as possible in order to train all employees for the new challenge and to be fit for the future.
Markus Schumacher, Head of IT at Biomo, is certain that „the early implementation of the new serialisation guidelines, and with just one single solution, is a Competitive advantage“ is. „Antares Vision is a perfect fit for our needs as a pharmaceutical company: Thanks to their efficient and professional project management, they also develop solutions for us as a medium-sized company. Customised solutions. For us, it's like travelling together with a strong partner at our side towards EU FMD compliance,“ adds Schumacher.
ATSFOUR provides a universal interface for communication management, even if different „management languages“ are spoken. (Image: Antares Vision)
Universal communication management interface
The intuitive ATSFOUR software provides a Universal interface for communication management, even when different „administrative languages“ are spoken. The software architecture enables the responsible departments at Biomo to seamlessly forward the necessary information to regulatory authorities, such as the EU hub. This is governed by Delegated Regulation (EU) 2016/161 with the aim of controlling the production and distribution chain of medicinal products in compliance with Directive 2011/62/EU.
Server or cloud solution
ATSFOUR offers Two different installation options: optionally either in the local server infrastructure of the pharmaceutical company, as was the case at Biomo, as they already had the necessary IT resources in-house and therefore the installation of ATSFOUR did not entail any major changes to the workflow. The server-based solution also makes sense for the company because the system itself continues to run without an internet connection.
The alternative is installation via a cloud platform: the ATSFOUR cloud solution can be installed in a single, centralised location compared to any other solution available on the market. specially designated cloud area that is not shared with other companies. ATSFOUR is equipped with „graph-database“ technology to handle the constantly growing volumes of data to be managed. This means that information can be retrieved much faster than with traditional systems - even when the volume of the database increases significantly.
Communication across all levels
With the unique all-in-one software solution, pharmaceutical companies can easily manage their data from the production level (ISA-95 Level 1) to the corporate level (Level 4) as well as reporting to regulatory authorities such as the EU Hub (Level 5). ATSFOUR is also compatible with all available systems, both downwards in terms of hardware and upwards in terms of software.
This also applies to the EMVO (European Medicines Verification Organisation) - the body that coordinates the activities of the EU hub. Antares Vision also fulfils the task of providing pharmaceutical companies with the best possible support during their on-boarding process as a liaison provider, which is another important step towards full compliance with the Falsified Medicines Directive.
The Print & Check EVO-TE serialisation unit with integrated tamper-evident module was specially developed to comply with and ensure compliance with the EU FMD Directive. (Image: Antares Vision)
Flexible system and competent service
For Biomo, it is important to ensure that both software and hardware a single flexible system to use. Service is also a very important criterion. „I usually receive a response from Antares Vision within just one day,“ says Schumacher, describing the high-quality service.
„The software is unique in managing communication at level 4 between the various players in the supply chain and the authorities of national data distributors. At the same time, it is completely flexible when it comes to connecting with other systems on the market,“ emphasises Emidio Zorzella, CEO of Antares Vision. „Our aim is to meet the specific needs of our customers,“ adds Massimo Bonardi, Managing Director and Technical Director of Antares Vision. „Our considerations always start with our customers in order to develop customised solutions that can simplify complex processes such as serialisation.“
Software and hardware
The German generics specialist Biomo has decided in favour of Antares Vision solutions not only at the software level, but also at the hardware level. In production, for example, the Print & Check EVO serialisation machine without integrated Tamper Evident Seal and with a separate stand-alone tamper unit, as well as the larger Print & Check EVO-TE with integrated Evident Seal tamper is used.
The Print & Check serialisation modules specifically support the serialisation functions, print all fixed and variable data on the boxes using an inkjet or laser printer and check the accuracy and completeness of the printed data. In addition to printing and checking the data matrix codes and variable data, the Print & Check labelling modules can be equipped with a checkweigher and/or tamper-evident closure modules for „French vignettes“ or „Italian Bollini“ and thus enable considerable space savings and flexibility for packaging lines.
