Operationalizing DSCSA Compliance in the Warehouse
There’s no question that the presence of counterfeit pharmaceuticals — in the healthcare supply chain and otherwise — is a very real problem.
In the United States, as elsewhere, fake medicines mean patients don’t receive the help they need — or, worse yet, they receive substances that can worsen their conditions. To prevent this, the FDA embarked on a multi-year crusade to combat drug counterfeiting, resulting in the development and enforcement of DSCSA serialization for pharmaceutical distribution.
For operations managers, 3PLs, wholesale distributors and pharmaceutical dispensers, compliance is becoming harder — and the pressure to get it right, both legally and operationally, is higher than ever.
Are you on a journey toward true compliance?
The Drug Supply Chain Security Act (DSCSA) serialization mandate is now in full effect. Every pharmaceutical distributor and 3PL must trace serialized product at the unit level and stay in sync with trading partners in real time. There are multiple ways to meet the minimum requirements — but only one approach delivers full compliance without operational disruption. Tecsys provides that solution: the most complete, warehouse-native serialization capability, built directly into core workflows so compliance happens automatically as you work.
There are three primary approaches to DSCSA compliance. Let's explore the pros and cons of each.
Option 1 Dual input workflow
- Two discrete systems are running at the same time.
- Repository is usually updated only twice: at receiving and at shipping.
- If pallets are broken down to cartons/packs/units and serial numbers are un-nested, the repository has no visibility to these activities.
- Errors and exceptions are difficult to track and resolve as there is no audit trail in the WMS.
- The wrong serial numbers can be shipped causing downstream issues.
- The ideal workflow would entail dual scanning at each warehouse event, causing bottlenecks and increasing chance of manual error.
- If inventory is received under inference, then items could be packed for shipping that have no data, causing shipping bottlenecks.
Advantage
This is the easiest process to implement in the warehouse and the lowest in initial cost.
Disadvantage
High potential for increased labor and operational cost due to additional handling requirements; least compliant.
Option 2 WMS interfacing with repository
- Two discrete systems are running at the same time, but interface with each other.
- The repository can be updated for each warehouse event, but latency will result in additional labor cost, processing time and order cycle time.
- Users will be motivated to “skip steps” to expedite processes.
- Errors and exceptions can be tracked but will take time and effort due to running separate systems.
- The same issues at shipping can occur as with a dual input workflow if the repository is not verified before the packing stage.
Advantage
This process is the most compliant of the dual system methods, and also has a relatively low initial investment.
Disadvantage
Potential for increased labor and operational cost due to additional handling requirements; latency and bottlenecks waiting for data. Potential for non-compliance if not followed correctly.
Option 3 WMS with embedded DSCSA compliance
- The WMS replicates the repository through data synchronization.
- The repository and WMS remain in sync without manual intervention.
- No latency as the WMS is not calling the repository for verification — it is verifying internally against its own database.
- The WMS creates a de-aggregated data audit trail.
- Errors and exceptions can be easily tracked and resolved.
- Since warehouse activities and de-aggregation events are synchronized and tracked within the WMS, it results in greater DSCSA compliance.
Advantage
The most compliant option and least disruptive to warehouse operations.
Disadvantage
Requires a rip and replace of existing software. Higher initial cost than other options but lowest total cost of ownership (TCO) in the long run.
Operationalizing DSCSA starts with the right WMS
The most reliable and least disruptive option for DSCSA compliance in the warehouse is with a WMS that directly embeds DSCSA data. Here's how it works:
Single source
WMS replicates repository data within the WMS database and becomes single source of DSCSA serialized transaction creations.
Continuous sync
WMS continuously syncs serial numbers to inventory management data as inventory becomes un-nested and updates the repository as events happen.
For example, if a pallet is broken down into cartons and stored in separate locations, this event is captured in the WMS and synced to the repository.
Modernizing healthcare logistics with Elite™ WMS
As the market leader in healthcare supply chain solutions, Tecsys' Elite™ WMS for healthcare distribution — with embedded DSCSA compliance — is designed to address the needs of high-cost-of-failure supply chains, specifically in the pharmaceutical and healthcare setting.
No dual entry
DSCSA compliance as a seamless component of a warehouse management system, rather than an add-on, to eliminate the need for duplicate processes.
Immediate readiness
Compliance comes out of the box – no additional integrations or interfacing required.
Full data synchronization
WMS inventory data and serialized data are synced across the entire life and format of the inventory.
True SaaS platform
Two feature releases and two minor releases per year, for optimal security, compliance and functionality.
Purpose built for healthcare
Leading vendor of end-to-end healthcare supply chain software solutions.
Deep customization
Built on the Itopia® low-code application platform, enabling deep customization without code modifications.
Built-in DSCSA serialization
Tecsys' Elite™ WMS for healthcare distribution is unique in that the system locally maintains full inference data on SGTIN and SSCC with fully embedded DSCSA regulations within each individual warehouse transaction. This offers real-time reconciliation of inbound and outbound inventory in tandem with the EPCIS repository.
Streamlined warehouse compliance
In addition to real-time compliance, this process also streamlines receiving, putaway and fulfillment workflows with no downtime for system checks. Furthermore, Tecsys’ Elite™ WMS embedded approach to DSCSA serialization compliance also means no additional time is spent manually reviewing records to maintain compliance.
What's next?
There’s no question that tackling the issue of DSCSA serialization compliance will take work sooner or later, but addressing the issues head-on now could pay big dividends in the long run. While half-measure solutions like a standalone repository might suffice in the short term, they are not viable solutions in the long run and will likely result in noncompliance with severe financial penalties.
