Pharmaceuticals.
Pharmaceutical serialization under DSCSA is out of scope here, deliberately — and it is one decision covering pharma AND medical devices, so the Medical Devices page on this hub carries the same statement. EPCIS has been mandatory in pharma for years, the segment is served by entrenched incumbents with validated/GxP audit histories, and this project has no customers in that segment, no validated/GxP documentation history, and no attestation — none has ever been issued — so it does not court that evaluation, and says so rather than pretending otherwise.
whospine:capturedBy
Out of scope, on purpose.
segment: pharma / DSCSA (cut with med-device — one §3.1 ruling)
status: out of scope — a deliberate cut, revisited
only after references exist
reason: validated/GxP buying environment (CSV documentation, supplier
qualification, audit history) that a pre-launch
project cannot honestly serve
what stands anyway: EPCIS 2.0 validation, CBV §8.9 hashing, append-only
storage — written, tested, and industry-agnosticThe scope statement, plainly. The standard's mechanics on this page are true everywhere; the segment call is a targeting ruling, recorded, not a limitation of the written gateway.
If you are here from a DSCSA program.
This gateway will not present itself as a validated-environment vendor, because it is not one. What the published package offers any EPCIS implementer — pinned official schemas, the standard's own event hash, RFC 7807 refusals — is checkable without believing anything on this page, and that is where this page stops.