Clearly, the new requirements go beyond just slapping a new label on your bottles. From a technology perspective, effectively meeting serialization requirements calls for integration of the Laboratory Information Management System (LIMS) with other key systems such as:
- Quality Management: An automated Quality Management System (QMS) or GMP Compliance Software is essential for complaint handling and tracking returns. Legislative and Regulatory tracking can also help you ensure the organization has controls or procedures in place to comply with the new (and future) traceability requirements.
- Supplier Management: Full traceability will only be possible by linking serialized products with materials from supply chain partners, including contract manufacturers.
- Shipping and Receiving: Tracking products efficiently requires shipping and receiving records linked with Supplier Management tools in the QMS.
More than just a practical consideration, an interoperable data exchange that facilitates traceability is one of the main goals of DSCSA. That means companies can no longer afford to manage compliance processes with one-off or manual systems—to be truly effective, they all need to be connected.
