DSCSA Compliance. We’ve Got it Covered.
The time for Pharmaceutical Manufacturers, CMOs, and CPOs to satisfy the DSCSA and trading partner requirements is now. PIMS Pharmaceutical Traceability solutions for DSCSA are integrated into the packaging of finished dose packaged drugs and complimented by a host of mobile applications used by logistics and sales order fulfillment personnel. For pharmaceutical manufactures who outsource manufacturing and or packaging, PIMS can also be integrated at the data level. PIMS DSCSA compliance is achieved through a combination of packaging machine integration using OPC DA and OPC UA. Automated and semi-automated processes supported by PIMS build the necessary serialization data and relationships that satisfy the DSCSA and trading partner requirements.
Contact us today to find out how we can help.
Traceability at Every Step in the Process…
- Packaging Machine Integration and Automation
- Inner Pack (Unit Level) GTIN-12, Lot and Expiration verification
- Multi-Unit (Carton Level) GTIN-12 verification
- Multi-Unit (Carton Level) Serialization and GS1 data matrix issuance and verification
- Shipper (Case Level) aggregation and serialization
- Case Level GS1-128 barcode with human readable Expiration Date, Lot Number and Case Quantity
- Case Level GS1-128 barcode with human readable Product Code (GTIN14), and Serial Number
- Case Level GS1-Data matrix barcode with product code (GTIN-14), case serial number, expiration date, lot number and quantity
- Pallet Level aggregation and Serialization with SSCC-18
- Semi-Automated Packaging Solutions
