As the global technology leader in anti-counterfeiting, product safety, and consumer and brand protection, serialisation pioneer Systech is shaping the future of authentication. Andy McLaughlin, Systech’s Director of Global Services Europe, shares his experiences in developing strategies and creating and implementing serialisation solutions in the European market and talks about how the company can help businesses get ready for the EU Falsified Medicines Directive, ensuring patient safety every step of the way.

Systech has more than 30 years of experience in protecting brands, from unifying and optimising authentication to providing enterprise serialisation and track-and-trace technologies that ensure regulatory compliance, mitigate risk, and drive efficiency and profitability.

The company’s innovations have led best practices for key brands across consumer packaged goods, food and beverage, aviation, automotive and life sciences. A particular focus for Systech lies with the pharmaceutical industry, where the company works with pharmaceutical companies, CMOs, and CPOs of all sizes around the globe.

Mr McLaughlin is proud to point out the scale of Systech’s serialisation solutions:

“To date, our solutions have been deployed on almost 1,600 packaging lines, which is 65 per cent more lines than our nearest competitor.”

As a serialisation innovator, Systech is trusted by top pharmaceutical companies worldwide, and the company is instrumental in guiding product and brand protection officers in their quest to improve patient and consumer safety, increase engagement, decrease counterfeiting, avoid diversion, and reduce harm to brands.

“Systech has provided the core vision capabilities for serialisation, aggregation and anti-counterfeiting solutions for decades, and this is of particular importance for the pharmaceutical industry. One of our key focus areas is to help companies comply with the numerous industry regulations, notably the EU Falsified Medicines Directive (EU FMD) here in Europe,” Mr McLaughlin says.

What does EU FMD entail?

EU FMD was enacted in 2011 as an anti-counterfeiting measure and demands the introduction of two safety features on each drug package, as well as an authentication system implemented by the pharma industry.

“An FMD Unique Identifier must be placed on each drug package or saleable unit in a machine-readable 2D code and in human-readable format. It contains the product code, a random serial number, the batch number, the expiration date, and in some EU member states, a national reimbursement number. This unique identifier must be applied to the outer packaging or the ‘immediate packaging’ in machine and human readable forms,” Mr McLaughlin explains.

It is not just about what is on the pack, the supply chain has to be tightly monitored too:

“In addition, the data for each package introduced into the market must be transmitted to the ‘European Hub’ via the European Medicines Verification Organization (EMVO). The EMVO will then transmit a copy of your data into the national repositories where you intend to distribute your product. Whenever drugs leave the supply chain for any reason other than dispensing to a patient, the unique identifiers on their packages must be decommissioned.”

Getting ready for EU FMD

These measures need to be in place by February 2019, and not all companies are ready, as Mr McLaughlin points out.

“Companies are most likely aware of the new regulation, but the challenge for most companies comes when they realise there are two parts to the solution – hardware and software. There is significant work to do to be compliant, and we have helped thousands of companies to get ready, but if businesses don’t act soon enough, they might be caught short especially on the hardware front, as some hardware suppliers might not be able to supply at short notice.”

Mr McLaughlin describes Systech as a ‘hardware agnostic’ solution provider, helping their customers based on their unique packaging requirements without any bias towards a specific type of hardware.

“At Systech, we are here to help, and we can either work with the customer’s current hardware vendors or help find different OEMs to match client needs.”

Support and testing

EU FMD is an important step forward in assuring patient safety but poses challenges to companies in the industry. Systech is in an ideal position to support these companies every step of the way, as Mr McLaughlin highlights:

“We pioneered serialisation, we have expanded our expertise over the past 30 years and benefit from the tried and tested methodology behind us. Our customers range from the largest pharma manufacturers in the world who have 200+ production lines running to smaller, specialised players. Our solutions can be configured to any size company, anywhere, with little to no downtime and full compliance to the specific regulation.”

He highlights the importance of data.

“Data is complex but crucial, and cooperation is key to get the different facets right, such as packaging information, inspection with a camera, dimension, and packaging types right at the very outset.”

Vendor management and preplanning are also key. From the OEMs, the customer’s production, packaging, brand, legal and executive teams, and other providers, all parties involved need to work together continuously, and the Systech serialisation solution allows for this interaction.

Testing following a foundational methodology is crucial to adhere to regulation. Systech utilises project management best practices based on GAMP guidelines to ensure client success. Customers can leverage Systech’s extensive documentation to make life easier for them, and the project will ultimately be more successful.

Best Practices for a successful project

At an early stage of a project, it is important to identify overall requirements – not just what product information should be supplied, but also markets the product will be shipped to and which regulations will apply.

“Understanding the issues at hand is key. For serialisation novices, this is new territory. Pre-planning and training are vital, so everybody understands what is happening and how to proceed throughout all phases of a project. We are a trusted partner to our customers as we are able to support and advise through every step of the process,” Mr McLaughlin is happy to report.

“We stand at the ready to help companies enact compliance regulation, based on time frame and individual unique needs. We are able to deliver custom solutions using our library of serialisation modules, so there is no need to create a solution from scratch every time. Partners can hook in their services with ours and vice versa. Systech provides a solution that is highly configurable and offers robust deployment to meet client needs. Our core serialisation product, UniSeries™, is agile enough to adjust to future regulations.” Project management and communication, sharing information, and being transparent is important. A strong project manager is assigned to each Systech client that makes sure that the right activities happen at the right time. Our core serialisation product, UniSeries™, is agile enough to adjust to future regulations.”

Project management and communication, sharing information, and being transparent is important. A strong project manager is assigned to each Systech client that makes sure that the right activities happen at the right time.

Systech offers a scalable compliance solution and can meet future regulations with ease. A partner programme provides training and support to companies in the fields of track and trace and serialisation. Post implementation, customers aren’t left out in the cold – support is available 24/7, 365 days a year.

Working from the heart of Europe

Mr McLaughlin is based at Systech’s European headquarters in Brussels, Belgium, from which work specific to EU FMD is managed.

“Besides our office in Brussels, we have an additional Systech office in Hull in the UK, and our partner organisations stretch from Scandinavia to Spain, and the UK to Germany, which provides us with a local perspective all over Europe, and puts us in close proximity to help our customers.”

Asked about Brexit and its potential implications for the industry, Mr McLaughlin says in conclusion:

“Brexit is most likely a long way away from having an impact on how companies should prepare for and address becoming compliant with the FMD. The UK will probably at the very earliest point follow EU regulation. Regardless of other political happenings, our mission is to help pharmaceutical companies ensure patient safety.”