There's just over six months left to the FDA's November 27, 2023 final enforcement deadline for the Drug Supply Chain Security Act. Since it's incredibly risky to leave a transformational compliance regimen to the actual last minute (fall 2023), that means the last minute is...well, now. Why is this the case, when there are still months left to go?
If you haven't yet begun the process of EPCIS onboarding, you can expect it to take up a significant amount of time and attention between now and the November 27 deadline — it's a multi-step process that must be repeated for every trading partner connection you have.
Given the complexity of the process and the critical importance of creating accurate, consistent DSCSA data exchange setups, you'll want every advantage you can get. Outsourcing to Proactive Resource Group can massively reduce your time, energy, and costs, enabling the process to be completely driven by a dedicated team of experts rather than requiring your own resources and management.
Under DSCSA’s interoperability requirements, every business in the pharma supply chain must form an interoperable connection with each of its trading partners. These connections exist not only to exchange data securely, but to ensure that any party involved can trace a given single product’s complete history through the supply chain, from manufacturing to the patient-facing dispenser. This is the goal of item-level traceability, ensuring that businesses can find and remove damaged, illegitimate, or dangerous products from the supply chain. From there, they can investigate the issue for related problems that may have wider effects.
Onboarding presents a steep technical challenge for many organizations, particularly those with large numbers of buyers or sellers. Any company in the pharma supply chain will need to be able to access the system of any given trading partner to exchange or confirm transaction data; for example, a company with 50 trading partners will need to support 50 separate point-to-point connections.
Each of these connections can take two to six weeks to complete, and it can take as many as eight more weeks to qualify a connection under the Computer System Validation requirement (from the FDA’s CFR 21 Part 11 compliance). This is an essential element, as misconfigured or incomplete data exchanges can cause delays and other serious impacts.
Effective collaborations on interoperability are essential throughout the supply chain. A single company’s efforts to comply with DSCSA serialization can still be ineffective if its data can’t be read by a partner. Similarly, an incomplete technical setup can make the exchange too labor-intensive to be easily repeatable. Companies that fall behind on interoperability may find themselves incurring extra costs for labor and problem-solving. Additionally, they risk losing out on the benefits of traceability.
The process of launching, managing, testing, and efficiently resolving all partner onboarding processes can be time-consuming for any team, whether you're a small business or an industry giant. In addition to forming and testing connections, the consistent communication required to get these done effectively means having professional compliance personnel ready to take on project management and lead these conversations.
The team at Proactive Resource Group has already mastered the technical requirements for EPCIS integration and common pitfalls, allowing them to provide precise guidance and support to trading partners. They can act as a central point of contact to coordinate efforts with your trading partners to lead scheduling, address concerns, clarify requirements, and ensure a smooth flow of information back to your leadership.
They're able to manage intricate details from system configuration to data mapping and validation, minimizing the burden for your company without sacrificing transparency. They'll also create robust communication channels and documentation that your company can rely on into the future.
Additionally, PRG can approach EPCIS onboarding with the security of having performed the same connections thousands of times, between organizations of all sizes and at all levels; there's no replacement for this kind of expertise. Software problems, misconfigurations, misunderstandings, and other issues that would be showstopping for most organizations are everyday knowledge for PRG's team, allowing them to skip through to the solution and give you a summary.
Working with Proactive Resource Group isn't just a benefit for your organization. Having experts leading DSCSA project management reduces stress for your partners as well, making their presence a benefit to your most important business relationships.
Putting PRG on point in your DSCSA implementation is a strategic decision that pays off: in the time you and your personnel save; the stress of managing the complex task of onboarding all your partners; the relationships you improve by having an expert authority leading the process; the cost of hiring FTEs to handle compliance; and skipping wasted money on trial and error.
Further, since PRG is equipped with LSPedia's solutions, you'll have the benefit of the industry's top technology and expertise in exceptions management. This prevents the transaction errors that stop shipments from being received, protecting your business relationships and ensuring that patients get the medications they need.