11 Mar Manually Created Serial Numbers – Handling Exceptions Without Losing Control

In a fully serialized and compliant pharmaceutical supply chain, every serial number matters. Systems are designed to ensure that each product received, stored, and shipped is backed by valid traceability data, usually provided through EPCIS files and aligned with DSCSA requirements.

However, real-world operations don’t always follow the perfect scenario.

When an Unknown Serial Number Appears

Occasionally, a shipment may arrive containing a serial number that does not match the expected data. This can happen due to a misshipment, packaging error, or incorrect aggregation at the source. In some cases, this incorrect serial number may bypass initial checks and be physically present in your inventory, even though no EPCIS data exists for it.

Under normal circumstances, the correct action is clear:

• The product should be returned to the vendor, or
• An EPCIS file containing the correct traceability information should be requested.

Without this data, the serial number is not traceable and not compliant with current DSCSA requirements. That said, there are rare operational exceptions where shipping this product becomes necessary.

Introducing Manually Created Serial Numbers

To support these exceptional cases, DOit ERP offers the ability to manually create serial numbers, a controlled feature designed to help your operation move forward when no other option is available.

Let’s look at a practical example.

A Real-World Scenario

Imagine a sales order for 4 units, and your inventory shows sufficient stock. The system contains only serialized inventory, meaning it knows exactly which serial numbers exist, and which do not.

During picking and scanning, you discover that one serial number inside a closed box does not match the expected data. Normally, this discrepancy would block the shipment entirely, since no traceable EPCIS information exists for that serial.

This is where the exception applies.

Using the manually created serial number feature, you can approve that unknown serial and proceed with shipping, while fully understanding the implications of doing so.

When you encounter one of these errors, separate the product from the rest, finish scanning, and when you’re ready, hit Next. The system will not allow you to scan the unknown serial number on this screen; another step will be required.

A pop-up screen will appear like this so you can fill in the information for your manually added serial number.

Now we can see in the S/Ns tab that this serial has been created but is waiting for approval, indicated by a black attention icon. If you hover your mouse over it, you’ll see a message stating that this serial was manually added.

After green check, someone with the proper permissions will also be notified on their computer and can approve it from their desk.

Important Considerations and Consequences

Creating a serial number manually is not the same as receiving one through EPCIS. It comes with specific consequences that must be clearly understood:

• The serial number will not have commissioning data from an EPCIS event.
• When invoiced, it will receive pseudo-commissioning information.
• The manually created serial consumes inventory quantity.
• If the serial is taken from a closed box, that box will be disaggregated, meaning it can no longer be scanned or handled as a closed unit in the future.

Because of these impacts, this process should be used only in exceptional situations, not as a standard workflow.

If you have any questions during the process, or if you are unsure whether this approach is appropriate for your situation, our support team is here to help. They can guide you step by step and ensure the process is handled correctly and responsibly.

By combining flexibility with control, DOit ERP helps you manage exceptions without losing visibility, compliance awareness, or operational integrity.