Every package starts with an identity.
The manufacturer serializes each package: product, serial, lot, and expiry, recorded as data that travels apart from the box.
Illustrative · planned network
Anyone can join. Anyone can build on it. Your data leaves in open formats, so no one can lock you in. OpenDSCSA operates the network on the standards the supply chain already uses.
Pharmacies must receive with data by at the latest. Everyone who ships to them has to be ready first.
Every shipment now arrives with tracing data, from a different supplier or portal each time. OpenDSCSA will check each package against that data, so staff shelve the routine with confidence and give every exception an owner and evidence.
The manufacturer serializes each package: product, serial, lot, and expiry, recorded as data that travels apart from the box.
Illustrative · planned network
The hard part starts when electronic records meet the physical shipment.
OpenDSCSA is being designed to turn package-level tracing into four explicit operational steps.
Ordinary data errors are kept distinct from quality concerns and staff determinations about suspect product.
The shipment arrived, but the tracing data it needs is absent or incomplete.
What was counted and what the data says disagree, so the item needs investigation and a documented resolution.
A separate operational reason, such as damage, keeps product off the shelf while authorized staff evaluate the facts and choose the next action.
The software assists with facts, policy, and evidence. The customer’s staff make every legal determination.
Manufacturers, repackagers, and wholesalers already send tracing data through the providers they chose. OpenDSCSA plans to connect those systems rather than replace them, so pharmacies receive with the data DSCSA requires and every partner keeps the connections it has. Software providers embed the same receiving and exception behavior in their own product instead of rebuilding it for each trading partner.
// Open format; implementation-neutral { "receipt": "ASN-84921", "arrived_and_counted": true, "summary": { "matched": 142, "missing_data": 2, "needs_review": 1 }, "release": { "authorized_by": "pharmacy_staff", "packages": 142 }, "holds": [ { "type": "missing_data", "count": 2 }, { "type": "review", "count": 1 } ] }
Pharmacies use the web app at no charge. Anyone can practice on synthetic shipments in the OpenDSCSA Lab, embed the SDKs, inspect the formats, and test implementations against public conformance behavior. Lab practice builds readiness, not certification. Open-source licensing is under review.
OpenDSCSA alone operates the network: message routing, supplier and partner connections, credential checks, six-year record retention, uptime commitments, and day-to-day operations.
Pharmacies join the waitlist for the free web app. Manufacturers, distributors, and software providers ask us to connect their network. Tell us which you are and we'll email you when there's something to show.
Thanks, you're on the list. We'll email you when there's something to show.
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