EU FMD compliance tool developed in response to pressing regulatory deadline

EU FMD compliance tool developed in response to pressing regulatory deadline

With the US DQSA compliance deadline now upon us and the EU FMD February 2019 deadline hot on its heels, now is the time for businesses to examine the current landscape of pharmaceutical serialisation, looking at the lessons learned from US businesses and how they can be applied to EU businesses ahead of deadline. It’s imperative that any business affected by the EU FMD regulations assesses their current position and their capability of delivering the data requirements in line with the directive. For any business facing potential non-compliance come 9th February 2019, I would like to take this opportunity to introduce a pioneering tool we’ve developed, which has the capability of delivering your data in the format required, in the event of any inter-system communication issues. This translation tool can assist those businesses who are already on the road to complete serialisation yet have found that, for a number of possible reasons, their planned solutions will not be ready in time. If your business is currently facing a potential interruption to the supply chain as a result of non-compliance, we have a short-term solution to deliver you to compliance in a quick, safe and cost-effective manner.

The problem

As specialist consultants in this field, at Be4ward we’ve seen a huge rise in the number of clients looking to us for serialisation solutions, more recently due to the failing of their ‘plan A’, clients who have found that their level 4 solution simply can’t support all the communication protocols that their CMOs are able to provide. Their planned serialisation system is not going to be ready by deadline and they’re facing either the resource drain of a manual transfer of the data files or a complete failure to deliver the data and the potentially catastrophic repercussions of non-compliance.

There are many possible reasons for these system failures. Miscommunication between immature and evolving systems can leave gaps in the data processing, or the enterprise systems adopted by some businesses may have been created as a ‘big picture’ solution but failed when faced with the uniqueness of a real business. In some cases, specialist serialisation solution vendors have oversubscribed and found themselves unable to service their fast-expanding client base. Some businesses may have faced a lack of available resource as the demand for troubleshooting solutions has risen to unprecedented levels, leading to a squeeze on the limited resource available in this very niche area. This has come about as a result of the US and EU deadlines hitting within less than 3 months of each other and we’re currently seeing this effect at play in the US and increasingly across Europe as the demand for the services of experienced consultants, IT and system providers soars, the limited pool of resource is drained.

What is clear from the situations facing many of these businesses is that a one-size-fits-all approach does not work as a solution to serialisation, the variables are too numerous. The needs and requirements of each individual business must to be examined and a bespoke solution applied. This was the case with one such Be4ward client who, after the breakdown of their plan A, could see non-compliance looming. Frustrated that their process was incomplete and finding themselves unable to comply within an ever-decreasing timeframe, they called upon our troubleshooting services as serialisation consultancy specialists. We examined their systems, identified the problem and created a solution.

The solution

In partnership with Jennason, a leading provider of product serialisation solutions, we have created a tailormade, bespoke solution to our client’s problem. We’ve developed a software capable of capturing, gathering and communicating the essential supply chain data required to ensure EU FMD compliance, specific to our client’s needs. This translation tool is capable of taking inputs from across the supply chain, reformatting and then delivering the data to any other system. Acting as a short-term, bridging device between miscommunicating systems, this tool takes existing output files from for example a CMO line, translates them as required and delivers the unique identifiers to their required destination system, for example EMVS.

Translation Tool Package

We assessed the suitability of the tool to meet our existing client’s needs and devised a quality and validation approach which maximised the leverage of the tool in addressing our client’s unique situation.

As a short-term serialisation solution, this tool comes with a host of benefits:

  • Bespoke: adaptable, custom-made software designed by industry experts to address your specific business needs.
  • Accessible: simple and easy to install, the software can sit on a standalone laptop to troubleshoot individual areas of the supply chain or be rolled out across a chain-wide system.
  • Cost effective: a low-cost solution to fixing a high-cost issue.
  • Rapid: with deadline looming your business can be compliant inside of 8 weeks.
  • Flexible: an ideal interim solution to ensure short-term compliance whilst the long-term serialisation landscape unfolds.
  • Universal: the software can be adapted to report data from any stage of the supply chain, in both Europe and US.
  • Tested: having passed its initial test phase the software is already in use.
  • Supported: the software comes with a dedicated client-support package from installation to aftercare. We offer a short-term solution, so you become compliant, coupled with long-term support, so you stay compliant.

This tool can be deployed to any business facing an interruption to the supply chain via non-compliance. It serves as a temporary, interim solution to ensure large scale businesses are still able to distribute product globally and for the smaller SMEs the software may prove sufficient to ensure long-term compliance. Contact us now so that we can assess the suitability of this software for addressing your immediate serialisation needs.

Regardless of what stage your business is at in its serialisation journey, should you have any questions about the EU FMD legislation or would simply like to request a copy of any of our serialisation booklets, please don’t hesitate to contact me at Stephen.McIndoe@be4ward.com

Be4ward provides specialist consulting services to the pharmaceutical and other highly regulated industries. We deliver value to our clients through a combination of deep subject matter expertise and excellent consulting skills. Whilst we have a thorough understanding of the supply base in our areas of focus, we pride ourselves on providing entirely independent advice to our clients.

 Available by request:
Serialisation Lessons Cover     Serialisation Legislation Cover     Booklet image (2)

For more information on serialisation, go to our free download section.