Enhanced drug distribution security · EPCIS · SGTIN
DSCSA serialisation and traceability records.
Record serials and aggregation as product is packed and shipped.
Serialization at the Point of Pack
SGTIN assignment, print-and-apply verification and vision checks happen on the line, with commissioning events raised as product is made — not…
Aggregation that survives rework
Parent-child hierarchies to case and pallet are maintained through repack, partial-case picking and returns, with decommissioning recorded and…
EPCIS Events on Every Move
Commissioning, packing, shipping and receiving events generate conformant EPCIS data with transaction information, history and statement for each…
What goes wrong today3 common problems
Serialization Sits in a Bolt-on System
A separate serialization layer means reconciliation between what was packed, what was aggregated and what was shipped — and reconciliation failures hold shipments.
Aggregation Breaks on Rework
Repacks, partial cases and returns break the parent-child hierarchy, and nobody notices until the trading partner rejects the EPCIS file.
Verification and suspect-product requests are manual
Responding inside the statutory window means someone searching records rather than a system answering.
Everything V5 does here5 capabilities
Serialization at the Point of Pack
SGTIN assignment, print-and-apply verification and vision checks happen on the line, with commissioning events raised as product is made — not batched afterwards.
Aggregation that survives rework
Parent-child hierarchies to case and pallet are maintained through repack, partial-case picking and returns, with decommissioning recorded and reasoned.
EPCIS Events on Every Move
Commissioning, packing, shipping and receiving events generate conformant EPCIS data with transaction information, history and statement for each trading partner.
Verification and saleable returns
Verification requests are answered against the serialization repository with the response logged; saleable returns are verified before restocking.
Suspect and Illegitimate Product Handling
Quarantine, investigation, notification and disposition run as a controlled workflow with the FDA notification clock tracked.
Standards Referenced
- GS1 EPCIS 1.2 / 2.0 and Core Business Vocabulary
- GS1 SGTIN and Application Identifiers for package-level identification
- 21 CFR 211 — packaging and labeling control
- 21 CFR Part 11 — electronic records
Common questions3 answers
- Does V5 replace our serialization vendor?
- It can cover site-level serialization, aggregation and EPCIS event generation. Where a corporate L4 repository already exists, V5 feeds it rather than replacing it.
- How are saleable returns handled?
- Returned packages are verified against the serialization repository before restocking; unverifiable product routes into the suspect-product workflow rather than back to available stock.
- What about aggregation errors?
- Aggregation is validated at each pack level with reconciliation before shipping, so a broken hierarchy is caught on the line rather than by the trading partner.