Month: October 2018

Over the last several years we’ve learned a thing or two about what separates a good or average system implementation effort from a successful solution implementation. Those that are great have a few things in common. Not surprisingly they all have great leadership, excellent communication and follow a plan.

In this blog, we’ll address some of the most critical steps to a successful solution implementation, and what we think is the recipe for success.

Selection is Everything

It’s very common for biotech and pharmaceutical companies to rely on solution providers for their serialization and compliance needs. Identifying and selecting the right solution provider is a lengthy and challenging process. The correct solution provider can mean successful long-term outcomes like supply chain optimization and cost savings, but choose the wrong solution provider, and your manufacturing lines could experience production and fulfillment issues or worse yet; they could come to a screeching halt.

Identify a Project Sponsor

While selecting right vendor is essential, it is just as important to identify the right internal project sponsor to work with the solution implementation team to communicate issues, risks, and status to their organization and work hand-in-hand with the vendor to resolve issues. The project sponsor is typically someone from within the business unit implementing the software, and they have overall internal responsibility and accountability for the success of the project. Finally, they ensure the solution provider delivers on the requirements identified in the Statement of Work or contract.

Create a Project Plan

It seems like a no-brainer, but often in haste to get started, project planning takes a back seat. A good solution provider will put together a project plan with activities and dates. The project sponsor should review the project plan with his /her internal team and make sure there are no issues. If there are dependencies, the project plan should reflect those dependencies.

Identify who will be responsible for updating the project plan and how often it will be updated and stick to it. Driving the schedule and activities helps to ensure implementation occurs on time – if the project plan deviates from the schedule – you’ll be able to communicate why and know the impact quickly.

Trading Partner Identification and Connection Requests

Identifying and alerting all trading partners before implementation not only helps the solution provider make quick work of onboarding trading partners, but also puts trading partners on alert for requests. Trading partners are busy too, and they work best when they know a request to connect is coming. Additionally, early identification of trading partners and their preferred method of connection identifies those with compatible systems and connections and those that do not. Knowing this will allow the implementation team to come up with strategies to address difficult connections and keep the project sponsor apprised of potential risks and issues.

Communicate the Status of Risks and Issues

One of the primary reasons system implementation projects fail is from lack of communication. Before implementation, it is wise to sit down with the project sponsor and solution provider’s leadership team to identify potential risks and issues.  For each risk assess the level of impact and outline a mitigation strategy. However, if a risk should ever become an issue, quickly elevate it to the project sponsor and leadership team. By the time a risk becomes an issue, it’s often too late to mitigate with little to no impact, so it’s best to have a plan to reduce risks to upfront and actively mitigate issues if they should occur.

Conduct Lessons Learned

It may sound cliché, but there is so much to be gained for both the customer and the solution provider by conducting a post-mortem or lessons learned. Even if implementation is a success, it is vital to document what went well. If the project was challenging, this step allows both parties to discuss what went wrong. If there are open issues, it will provide the vendor the opportunity to resolve it for the customer. A good solution provider will always work hard to resolve any issue and make sure things are right and fixed before handoff.

Final thoughts

While there are more steps to any serialization implementation effort, at a minimum follow these, with them you’ll avoid common pitfalls, without them, you’ll experience unnecessary delays and certain difficulties.

Contact us today to learn more about our approach to successful solution implementation, serialization and our track and trace solutions.

Russian Federal Law No. 425-FZ, the law requiring serialization in Russia, gives pharmaceutical companies until January 1, 2020 to be fully compliant. This means pharmaceutical companies have less than a year and a half to comply with the most complex serialization requirements to date – without the Russia Serialization requirements fully established and written. 

What We Do Know: 

While it is unknown how the requirements for serialization in Russia may change over the next year, pharma companies who wish to sell their products in Russian markets cannot rely on there being another delay for the deadline. To ensure they can sell in Russia, companies must start to prepare for Russia serialization now. 

The requirements that have been put forth by the Russian government are some of the most complex serialization requirements yet. Currently, companies who wish to sell their products in Russia after January 1, 2020, need to make sure their products are traceable at a unit and a batch level from the creation and packaging of the product to the dispensing of the product. Beyond unit-level traceability, Russia has many requirements surrounding the aggregation of a product. Russia will require special reporting and documentation surrounding the disaggregation and aggregation of units and batches. 

While many serialization requirements for other regions – such as the EU FMD or the USA DSCSA – require only prescription medication to be serialized and traceable, Russia’s regulation requires all medication to be serialized and traceable, including over-the-counter medications. This is a major departure from the global status quo, and a departure that producers of over-the-counter medications are not prepared for. 

What Pharma Companies Need to Do: 

Companies that have not  started preparing for Russia serialization need to start immediately. The uncertainty surrounding the final regulations means that pharma companies need to be prepared for anything – their serialization solution needs to be agile and flexible.  

Due to the comprehensiveness and complexity of the serialization requirements, companies need to be able to produce the type of data Russia will require, as well as be able to produce serialization data for all of their products, including over-the-counter products. Companies that have not yet started converting their production lines need to do so immediately if they wish to sell in Russia. 

Contact us below to learn more about Russian serialization requirements and how rfxcel can help you meet them in time.

To learn more about Russian Pharma Compliance click here.

The food industry is undergoing massive changes. Consumer behaviors are changing the way food companies’ source and manufacture foods. A growing amount of food dollars are looking to brands that can make – and validate – claims of local, organic, sustainable and a host of other value-added food attributes. In this environment, companies operating in the food and beverage industry need to have deep insight into their supply chains to compete. Companies that don’t know what’s happening to their products in the global marketplace are at risk, and their supply chains aren’t the assets they should be.  

Digital, end-to-end serialized traceability originally developed and deployed across the global pharmaceutical industry to fight fraud and counterfeiting, provides an essential tool in winning the food game in the new food economy. End-to-end serialization helps to ensure that companies are protected today, and ready to adapt to the challenges of tomorrow. 

Serialization is the process of creating a unique identifier or code for every item sold. Some estimate that serialization can add four orders of magnitude to supply chain visibility in a single step. How? Well, once products are serialized a batch is no longer just thousands of undifferentiated packs, but single, traceable items that have quality metrics associated with their data. Data about the product starting with harvest through its journey to consumer can be tracked at every stage of the supply chain.  

Serious leaders in the food and beverage industry understand that item-level traceability is the future and are beginning to take advantage of what it has to offer. Importantly, the costs for implementing serialization solutions are coming down at the same time the benefits are becoming indispensable. 

FIGHT FRAUD AND COUNTERFEITS 

Food companies rely on brand promises to drive consumer loyalty, but Food Fraud – including mislabeling and brand counterfeiting – costs businesses $30-$40 billion a year globally. Counterfeiting in high-value products like specialty foods and spirits costs brand value. By labeling products with a unique code, consumers can validate the authenticity of products. Serialization helps to ensure that returned products are authentic, allowing for retailers or distributors to put items back on the shelf with confidence.  

REDUCE IMPACTS OF CONTAMINATION OR ADULTERATION 

No matter the rigor of food safety protocols, product recalls due to contamination or adulteration are still possible. However, by serializing each product, the size and scope of any recall can be reduced. Each item has a unique identifier that is put into a case which has its own unique identifier. When these cases are loaded onto a pallet, the pallet receives another unique number. By creating and following these parent-child relationships through aggregation and then de-aggregation and distribution, targeted, surgical recalls become possible, ensuring that only impacted product is pulled, while allowing for a safe product to stay on the shelf. 

GENERATE SAVINGS FROM THE SUPPLY CHAIN  

Getting accurate, real-time data about a product’s disposition is the driver behind the informed decision making that will allow tomorrow’s winners to leverage item-level traceability for competitive advantages. 

That visibility enables a better understanding of the product flow to improve logistics and transportation efficiency, including reverse logistics, and quicker and better decisions for demand forecasting and production planning.  

Being able to see exactly where products are and how long they have been there can reduce losses due to shrink, out-of-stocks and other ills of inaccurate/incomplete inventory. Companies can identify exact locations of bottlenecks in production or key QC points of failure.  Any issues from customers or even consumers can be traced back to the individual item. Just-in-time inventory can become a reality. 

CREATE OPPORTUNITIES TO NUTURE BRAND LOYALTY 

As end-to-end digital traceability becomes the expectation of consumers, serialization will open the door to unlocking the potential of innovative food brands eager to connect with their customers in new and powerful ways.   

By leveraging the unique code on each pack, marketers can use specified incentives and targeted digital messaging to connect with consumers. Companies can talk to consumers to communicate specific messages about ingredients, provenance, harvest date and other relevant information that can help build trust, including handling/testing data for the very item in hand. Couponing, incentives and other brand messages can build brand loyalty and provide targeted incentives to keep consumers coming back – the key to brand development.  

Serialization has become the primary requirement in the pharmaceutical industry, and well-known companies leverage the benefits of item-level track and trace. The leaders in the food industry can realize many of these same benefits. As we’ve seen in other markets, it’s only a matter of time before the benefits of serialization become indispensable.  

The Falsified Medicines Directive (FMD) imposes strict serialisation requirements on pharmaceutical manufacturers, distributors and dispensers. By February 2019, Marketing Authorisation Holders (MAHs) will need to start uploading serialisation codes for almost all their prescription medicines to the European Medicines Verification Organisation (EMVO) hub for authentication with pharmacists at the point of sale. Those that can’t will simply be unable to sell their products in Europe.

More than thirty countries in the European Economic Area will have new rules for coding and verifying prescription medicines. Despite the significance of the regulation, there are some pharmaceutical manufacturers – and many pharmaceutical dispensers, including community and hospital pharmacies – who have yet to put a strategy in place to assure compliance.

The introduction of serialisation, designed to ensure the authenticity and traceability of individual medicines, promises to improve patient safety and create exciting opportunities for digital health. However, failure to comply with the EU regulation that mandates it means you cannot legally ship your product. No code, no trade. And those in the driving seat are MAHs. We’ve had two-and-a-half years of the three-year implementation window: now, what’s left to do?

Its key to mention, that those of you waiting for Brussels or Brexit to cancel FMD are wasting your time. Even if there is a delay, FMD is not going away and the UK is tied to it until at least Dec 2020.

It is clear that not everything will be ready by February 2019, especially at Pharmacy level, but that doesn’t mean the whole project will stop.

Therefore, rfxcel have put together their top tips to rapidly implement a cohesive serialisation solution.

Simple FMD projects work best.

Only make system linkages you need. Usually (for manufacturers) that means MAH to CMO and MAH to EMVO. For distributors and dispensers it means to your national system (NMVO). While it would be possible to integrate your FMD solution with your ERP software, warehouse system, dispensing software – even your Apple watch if you want to – right now the focus should be entirely on the critical path for FMD compliance. Starting with a standalone approach as part of a roadmap to deeper integration is the best balance of risk and ROI.

Spend money on those that matter.

For every euro spent on vendor technology, several euros need to be spent on your own people and processes to bend them into shape. Don’t skimp on this bit. Pack-level traceability changes everything all along the supply chain. If people carry on with old ways of working your FMD project will fail: expensively.

Experience outweighs the price.

Saving a few thousand euros using unproven, but cheap serialisation vendors, is a false economy if you can’t sell or dispense products by next February. It is too late for home-made solutions or inexperienced me-too suppliers. Competition means that prices are already pretty keen amongst the market leaders. Don’t chase the last cent.

You still have some time.

There is still some time to get ready if you just need software to manage and report serial numbers (e.g. to the European Medicines Verification Organisation, EMVO) or if you’re a downstream distributor or pharmacy needing to verify and decommission packs. If you haven’t started, but can make quick decisions and take standard options, ACT NOW, and you could have your software implemented within the next few months.

Take action before regulators remove your right to trade.

The fact remains that many companies are still some distance from being fit for purpose. The complexities of serialisation mean that a failure to act now could make it extremely difficult to complete implementation in time for the FMD deadline, or at least to guarantee a seamless end-to-end process.

Moreover, with the fees for registering with EMVO and other affiliate repositories increasing, the internal costs of your project will inevitably rise the longer you wait. However, the biggest price of non-compliance will be your inability to ship product. So why risk it?

Contact us below to learn more about serialisation requirements and how rfxcel can help you meet them in time.