Taking Serialization Beyond Regulatory Standards with the Schneider Electric Life Sciences Serialization Suite
Serialization compliance marks an important milestone for the life sciences industry with several countries setting new regulations for traceability of prescription drug and biologic products. In order to facilitate this, the serialization process has to be put in place beforehand. Today the majority of the world is adopting the GS1 Standards (www.gs1us.org) in their serialization process.
Undoubtedly, serialization has many advantages benefiting both end users and pharmaceutical manufacturers alike. Serialization enables a drug to be tracked and traced electronically as it passes through the supply chain. This means that at any point, authorities and pharmaceutical companies are able to:
- Identify and stop the distribution of counterfeited drugs
- Contain and track the source of contaminated drugs back to its source
- Handle product recalls more efficiently and effectively
Life Sciences Serialization Suite: The Schneider Electric Value
Some pharmaceutical companies have already started implementing the serialization process. One of the biggest challenges is implementing a serialization solution with data that can be easily harmonized with existing operations management solutions, such as a Manufacturing Execution System (MES). The Life Sciences Serialization Suite by Schneider Electric is a turnkey offer that brings harmonization between legacy production applications, such as MES and Quality systems, providing an all-inclusive track, trace and reporting solution for a line, a site, or the enterprise.
Thanks to out-of-the-box integration with MES/ Quality applications, the Life Sciences Serialization Suite enables:
- End-to-end Track and Trace from manufacturing through Supply Chain
- Integrated analytics from production to the end user
- Real-time supply chain visibility, enabling more accurate planning and scheduling decisions
With the Life Sciences Serialization Suite, speed to deployment is faster, reducing the Total Cost of Ownership for pharmaceutical companies, with less substantial changes to the underlying manufacturing systems and business systems.
Integration of serialization data back into the MES makes it possible to have real time visibility across the supply chain, from the manufacturing world, right up to the end consumer.
Key Features of Life Sciences Serialization Suite
- Ability to easily create templates such as:
- Aggregation at each parent in the packaging hierarchy
- Serialization at each level without aggregation
- Serialization at a specific level
- Flexibility to switch between GTIN and SSCC codes at any level
- Specific modules for rework and printing
- Out-of-the-box integration with native MES applications
- Localization capabilities
- Analytics and reports such as:
- Serialization – OEE (Overall Equipment Effectiveness) comparative analysis
- Tracking by serial number – stock overview, usage analysis, wastage analysis, SKU serialization report