SSCC, SGTIN, and event repositories—supply chain visibility that survives audits and partner variance.
Trace every unit—serialization events that match DSCSA and partner EPCIS expectations
We implement pack-to-pallet aggregation, commissioning events, and shipment notices aligned to GS1 identifiers your CMOs already emit. Exception queues catch malformed EPCIS or mismatched SSCCs before product ships—when fixes are cheaper than recalls. Downstream verification and suspect product workflows give QA and legal a single investigation timeline—not spreadsheets across three systems.
01 // THE MANDATE
SSCC, SGTIN, and event repositories—supply chain visibility that survives audits and partner variance.
We implement pack-to-pallet aggregation, commissioning events, and shipment notices aligned to GS1 identifiers your CMOs already emit. Exception queues catch malformed EPCIS or mismatched SSCCs before product ships—when fixes are cheaper than recalls.
Downstream verification and suspect product workflows give QA and legal a single investigation timeline—not spreadsheets across three systems.
02 // ENGINEERING
Development process
Structured phases—from discovery to launch—with clear ownership and handoff points.
Regulatory scope (weeks 1–6)
MVP (weeks 6–18)
Site qualification (weeks 14–24)
Production (weeks 22–30)
Operate (ongoing)
03 // CAPABILITIES
Core Capability Matrix
The building blocks of your solution
Master data
GTIN; lot; expiry; packaging hierarchy.
Serialization
line interfaces; rework; scrap events.
Aggregation
case; pallet; disaggregation rules.
EPCIS
inbound/outbound; partner profiles.
Verification
VRS hooks optional; response routing.
Exceptions
quarantine; investigation; CAPA links optional.
Reporting
pedigree export; audit packages.
API
WMS; ERP lot sync.
Security
signing keys; role segregation.
Compliance
DSCSA milestones; EU FMD patterns optional.
04 // DELIVERY LIFECYCLE
The strategic roadmap
Milestones and checkpoints—each phase has a clear outcome before the next begins.
Weeks 1–6: Architecture and SOP alignment.
Weeks 7–16: Lab line integration.
Weeks 17–24: Partner EPCIS certification.
Weeks 25–30: Go-live with hypercare.
Ongoing: Serialization upgrades; market expansions.
05 // PRODUCT SCOPING
Choosing your path
Two engagement models—start lean and iterate, or commit to a full platform build from day one.
MVP
Speed & essentialism
Full product
Enterprise maturity
06 // PARTNERSHIP
Why work together
A single accountable partner across strategy, build, and go-live—not a revolving door of vendors.
End-to-end ownership: discovery, architecture, implementation, and launch—with clear communication and production-grade engineering.
- Discovery & alignment
- Systems that scale
- Implementation depth
- Clear comms
07 // CLARITY
Frequently asked
We implement controls your QA validates—audit trails, e-signatures optional, IQ/OQ support.
08 // MORE SOLUTIONS
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Tell me about your product goals and timeline—I'll respond with a clear path forward.