What Software Do You Need to Be DSCSA Compliant?
With the fast approaching DSCSA 2023 requirments now 16 months away, many pharmacuetical stakeholders from manufacturers to dispensers are asking this question. DSCSA has been especially challenging to predict what is needed for the more complex requirements related to interoperability. This gets even more difficult to understand as you move down the supply chain towards dispensers.
We believe the best way to begin any significant supply chain change, is by making sure you understand:
- What requirements does your organization need to meet both now and in the future?
- What gaps do you have to meet those requirements?
- What options should you consider to mitigate those gaps?
We have addressed questions 1 & 2 in previous posts and articles which you can find through the links here:
For question 3, we would like to share a few thoughts to consider as you look to understand what software may be involved in mitigating DSCSA gaps.
- Is there a procedural or existing solution options that might cover the gap? While some gaps may be best covered through a software solution, you may be able to meet part or all of some requirements more optimally with adjustments to procedures. This is especially important in areas that are still not fully baked in industry discussions, standards and related workgroups.
- What types of software do I need to look at? DSCSA is more than just tracking serial numbers and your company should consider if you have the right systems related to managing receipts, shipments, sales transactions, inventory management and quality management just to name a few.
- Do I need an L4/L5 Serialization Solution? A serialization L4/L5 systems may be needed but many are not aware that there are many options that will vary depending on your requirements (markets served, trading partner requirements, technical capabilities, existing systems, etc). You should not assume you must sign up with a solution provider soley based on a trading partner utilizing that system. All solution providers will need to be interoperable with trading partner systems that are aligning behind standards such as GS1 EPCIS messaging. There are also options developing through 3PLs and distribution partners but you should understand their strengths/limitations and if selecting a single partner may make flexibility difficult as your oganization grows.
- Will your solutions provide clear coverage in the case of a suspect/illegtimate product investigation or an audit by federal or state regulators? This question also requires significant details and documentation but a key point is understanding if the solution provider you are selecting is committing to being readily available in the event of DSCSA outined situtations in a manner that allows you to comply with the timing requirements of the law or related guidances.
- Does a selected solution provider have the resources and bandwidth to ensure you are covered in time? With the limited runway left and the complicated aspects of integration, you should make sure the provider is comfortable that they have the resources available to support and a plan to address spikes in demand or manage taking on new work.
The most important points we can make, is that you should understand what your organization needs and that you should explore what options are available before committing to what will likely be a long term and critical partner in your DSCSA compliance!
Don't Get Lost in the Approaching Wave of DSCSA Solution Demand
We are glad to provide advisory DSCSA service for all sectors of the supply chain and are available to help plan your organization's DSCSA compliance journey.
Feel free to reach out to us through TenCountConsulting.com/contact if you have any questions or just want to chat!