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Meet Important Deadlines
• FDA DQSA (effective Nov. 2014) and California state regulations
require more strict serialization of packaging lines*This affects not only manufacturers, but wholesalers, distributors,
3PLs and more
• Designed to increase effectiveness of traceability, helps make
accurate audit trail data more available
Reduce Supply of Counterfeit Drugs“Increase Patient Safety”
• More closely monitoring and tracking the origin of finished
pharmaceutical products and raw ingredients can reduce chances
of counterfeit drugs reaching consumers
Increase Efficiency of Recalls“Maintain Brand Reputation”
• Increased traceability allows for more efficient tracking of
production lines, LOT, SKU, etc. to perform more targeted recalls
Reduce Operating Costs
• Real-time capture of more accurate data:• Helps to reduce chargeback fees associated with
packaging errors and incorrect shipping
• Assists in controlling costs associated with inventory
storage and movement
Before You Serialize…
1. Learn more about what regulations affect your business and how.2. Develop a plan to implement serialization that will meet your
needs and deadlines.
3. Research WMS vendors to assist your business in the process.