{"core-extras.96d330537a":"Base IR","core-extras.bee831a169":"Substrate","core-extras.61a0822826":"Apps on Core","core-extras.15438cc098":"not supported","core-extras.ad565d9d01":"Feature","core-extras.0155bf03e5":"Segment legend","core-extras.8b7110078e":"Algorithm groups by data type","core-extras.25ab4276a6":"Scrollable capability matrix","page-breadcrumb.c766e66518":"Breadcrumb","section_st_a1_display-split.7c9a7c0610":"Detail","section_st_f1_cta-dark.90e40d5043":"Get started","uc-pharma-business-glyph.ba12c1d424":"The release packet","uc-pharma-business-glyph.109b876195":"Assembled while the batch moves","uc-pharma-business-glyph.9b6f56b2cb":"At release","uc-pharma-business-glyph.a381ca8bce":"From intake to release","uc-pharma-business-glyph.d9e7bddeb5":"Intake","uc-pharma-business-glyph.f7b18127a7":"Assay","uc-pharma-business-glyph.785ca95268":"Stability","uc-pharma-business-glyph.e29a79fe0c":"Review","uc-pharma-business-glyph.d41f56cea1":"Release","uc-pharma-business-glyph.67dd754ce7":"The record stays joined","uc-pharma-business-glyph.1275363397":"In the packet at release","uc-pharma-business-glyph.a820f28e36":"Assay result","uc-pharma-business-glyph.4ceaa3bd5b":"Measured against the specification","uc-pharma-business-glyph.e0bf173ba3":"Governing rule","uc-pharma-business-glyph.7165b280d8":"The version in force","uc-pharma-business-glyph.b23cbd1e16":"Qualified person","uc-pharma-business-glyph.13e771adde":"Who released the batch","uc-pharma-business-glyph.ba833d1e79":"Model version","uc-pharma-business-glyph.af4dd05b87":"What produced the result","uc-pharma-business-glyph.a1abb394ea":"Ready for inspection without rebuilding","uc-pharma-business-glyph.601eb30b3a":"Runs in your jurisdiction","uc-pharma-consumer-glyph.26d918cf74":"The record behind your medicine","uc-pharma-consumer-glyph.beddd81381":"Kept together, not scattered","uc-pharma-consumer-glyph.919003799d":"Tested","uc-pharma-consumer-glyph.b2bc0c005f":"Checked","uc-pharma-consumer-glyph.6e3665d85f":"Signed","uc-pharma-consumer-glyph.7bc0c49c5b":"Yours to ask for","uc-pharma-consumer-glyph.c12de790d3":"One line runs through all three","uc-pharma-consumer-glyph.e94ce951cd":"Ask what was checked","uc-pharma-consumer-glyph.6ad8b96d13":"The record names it.","uc-pharma-consumer-glyph.40f727d271":"Report a side effect","uc-pharma-consumer-glyph.839dc802fd":"It reaches the right desk.","uc-pharma-consumer-glyph.1c6c459f56":"Keep the answer","uc-pharma-consumer-glyph.7f8ff3ae69":"It stays with the batch.","uc-pharma-consumer-glyph.b50a21090c":"Your details stay private","uc-pharma-consumer-glyph.ca1f19570c":"Held in Europe","uc-pharma-technical-glyph.33b8f4fd98":"Release chain","uc-pharma-technical-glyph.8d42ccd736":"batch, assay, rule, signature","uc-pharma-technical-glyph.17d120d8bb":"Replayable","uc-pharma-technical-glyph.24ff2af86b":"Release lane","uc-pharma-technical-glyph.ac498dae57":"Specification corridor","uc-pharma-technical-glyph.2977a6249f":"Assay track","uc-pharma-technical-glyph.be31ab2456":"Signature chain","uc-pharma-technical-glyph.d9e7bddeb5":"Intake","uc-pharma-technical-glyph.f7b18127a7":"Assay","uc-pharma-technical-glyph.785ca95268":"Stability","uc-pharma-technical-glyph.e29a79fe0c":"Review","uc-pharma-technical-glyph.d41f56cea1":"Release","uc-pharma-technical-glyph.1c013851a3":"What the record holds","uc-pharma-technical-glyph.c0f85d6679":"Replay","uc-pharma-technical-glyph.4c13fe7983":"bit exact","uc-pharma-technical-glyph.e4cf039229":"Signatures","uc-pharma-technical-glyph.b8d6b8a761":"Safety reports","uc-pharma-technical-glyph.64e63eea6a":"Residency","uc-pharma-technical-glyph.1e9cb061f2":"European Union","uc-pharma-technical-glyph.34492da1ce":"In the packet","uc-pharma-technical-glyph.8bf1ef5668":"Batch","uc-pharma-technical-glyph.a820f28e36":"Assay result","uc-pharma-technical-glyph.e0bf173ba3":"Governing rule","uc-pharma-technical-glyph.b23cbd1e16":"Qualified person","uc-pharma-technical-glyph.ba833d1e79":"Model version","uc-pharma-technical-glyph.1d197d39c5":"Where it runs","uc-pharma-technical-glyph.89178d7783":"Integrate via API","uc-pharma-technical-glyph.195920b8ed":"Hosted in the EU","uc-pharma-technical-glyph.46a62054bf":"Air gapped","uc-pharma-technical-glyph.b211ddf1d4":"Signed at release, not rebuilt after","uc-pharma-technical-glyph.601eb30b3a":"Runs in your jurisdiction","use-case-pharma.2e66163f82":"Pharma & life sciences","use-case-pharma.14a29ba383":"Use Cases","use-case-pharma.4da385469a":"Existing LIMS, ERP, and QMS systems keep working. Dweve wraps them in a deterministic\n            decision layer that records every assay, every method, and every QP signature as\n            the release happens.","use-case-pharma.eba9a519a0":"Pharma, technical","use-case-pharma.e7332f9619":"Your choice","use-case-pharma.8bf34da1c7":"One platform","use-case-pharma.ea99002d5d":"Closed bundle for the most sensitive trial data.","use-case-pharma.ec9dfc4fd3":"Fully offline","use-case-pharma.86c49c67b3":"Run on GxP-qualified servers in your data centre.","use-case-pharma.c4f4d6cb73":"Your qualified hardware","use-case-pharma.55423877a1":"Dweve-operated public Mesh; processing boundary documented in the agreement.","use-case-pharma.61810d3c5a":"Business Workspace","use-case-pharma.2b1884c5a7":"One platform, three postures","use-case-pharma.215475056e":"WHERE IT RUNS","use-case-pharma.92a16f5060":"SDK: TS/Python/Go/Rust","use-case-pharma.4b3258f7ec":"RFC 7807","use-case-pharma.92af23aac4":"PROTOBUF","use-case-pharma.dabbb6f4e1":"OPENAPI 3.1","use-case-pharma.28fa57065c":"Integrate via REST or gRPC against a typed OpenAPI 3.1 surface. Managed through Fabric on the public Dweve Mesh for pilots. Licensed for GxP-qualified hardware. Air-gapped for the most sensitive trial data. Same API, same trace format, same replay packets across all three.","use-case-pharma.0ff8b5b425":"Three deployment postures.","use-case-pharma.94188e2c6c":"One API.","use-case-pharma.34bfbaefff":"How you integrate","use-case-pharma.80b30e032e":"Bit-identical output","use-case-pharma.4d62ce427e":"Same method","use-case-pharma.6e86380b3f":"QP signs the final release.","use-case-pharma.8eeb40cd07":"Sign packet","use-case-pharma.646d802948":"Registered spec applied to the result.","use-case-pharma.f2a9327c7f":"Apply spec","use-case-pharma.189ad02459":"Validated method produces a raw result.","use-case-pharma.1c2b8e1b81":"Run method","use-case-pharma.d95feda344":"Inputs logged before the method runs.","use-case-pharma.9678dd9fa7":"Pin inputs","use-case-pharma.478360978f":"Four guarantees","use-case-pharma.c00f9811f5":"WHAT THE LAYER DOES","use-case-pharma.3b720bec28":"SIGNED REPLAY","use-case-pharma.6757848af7":"DETERMINISTIC","use-case-pharma.c2a9cd6067":"Existing LIMS, ERP, and QMS systems keep working. Dweve wraps them in a deterministic decision layer that records every assay run, every validated method, and every QP signature as the release happens. The replay packet is the audit artefact. The systems of record keep doing what they do; the layer around them records why the release happened. The packet is written as the release happens rather than rebuilt from logs afterwards, which is what makes it an artefact instead of a reconstruction.","use-case-pharma.fb834ca63c":"bit-identical replay.","use-case-pharma.4f419104d3":"LIMS wrapped,","use-case-pharma.bbd0387cd1":"Assay determinism","use-case-pharma.ac0179f1db":"One signed signal","use-case-pharma.01c501a76c":"Four steps","use-case-pharma.e8eb09e014":"Reviewer signs; packet is the audit artefact.","use-case-pharma.60143fb6fc":"Sign the signal","use-case-pharma.c812cf5f0a":"Threshold rule versioned and signed.","use-case-pharma.841043d92a":"Apply threshold","use-case-pharma.c13f19d065":"Each score records the model version used.","use-case-pharma.24d7e65b40":"Pin to model","use-case-pharma.937aba77ae":"Pull ICSR from the E2B gateway.","use-case-pharma.ca910a486d":"Ingest E2B","use-case-pharma.9460aff3f9":"PV PIPELINE","use-case-pharma.1779864412":"PINNED","use-case-pharma.a03382e55f":"ROR","use-case-pharma.4fdd7d2fb8":"PRR","use-case-pharma.17742a3bc1":"EBGM","use-case-pharma.4087c3b5cd":"Pharmacovigilance signal detection is the workflow most damaged by float drift and E2B version skew. Dweve runs the signal scoring on integer arithmetic, pins to a specific EBGM model version, and ships the same flag every time. The packet is the audit artefact. Four steps stand behind a signal: the ICSR is pulled from the E2B gateway, each score records the model version that produced it, a versioned threshold rule is applied and signed, and a reviewer signs the signal itself.","use-case-pharma.4bc35b4501":"Signal detection,","use-case-pharma.1990cad46b":"Pharmacovigilance analytics","use-case-pharma.5d9d8d49dc":"The decision layer never crosses a trust boundary that fails the GxP or 21 CFR Part\n            11 rules. The same topology ships on all three postures.","use-case-pharma.d5a9f6f81a":"Three postures","use-case-pharma.8ab2c84ed7":"One architecture","use-case-pharma.ffdcb570f4":"No outbound calls. Optional EU-only EMA endpoint.","use-case-pharma.8e05a902ed":"Egress","use-case-pharma.8c0e6f760f":"Signed packets written once, read many, EU-only replica.","use-case-pharma.dcf17fd359":"Packet store","use-case-pharma.6de6f8a697":"CPU-native engine, no GPU farm, no cloud ML APIs.","use-case-pharma.7f59a1f1d5":"Decision","use-case-pharma.7d853df929":"TLS terminate in EU, mTLS to the decision layer.","use-case-pharma.92096d78df":"Ingress","use-case-pharma.7f166ac611":"Four boundaries","use-case-pharma.338ac926aa":"TOPOLOGY","use-case-pharma.6b4217aac7":"EU ONLY","use-case-pharma.5e905a995e":"PACKET STORE","use-case-pharma.138a224dc4":"DMZ","use-case-pharma.2cf366a8a8":"Three operating models, one evidence architecture. Managed Fabric runs on the public Mesh. Licensed operation brings direct products to GxP-qualified hardware. Air-gapped operation protects the most sensitive trial data. Each model keeps decisions and evidence inside its declared trust boundary. The same four boundaries are drawn in each one: an ingress that terminates TLS in the EU, the decision layer behind the GxP boundary, the packet store, and an egress that makes no outbound calls.","use-case-pharma.3ae8029f90":"per posture.","use-case-pharma.52c48d0dc9":"Where the layers sit,","use-case-pharma.f9790fb715":"Deployment topology","use-case-pharma.2c2bb99178":"Determinism is asserted in the suite, not promised in prose. The same oracle run on\n            your hardware produces the same answer as on ours.","use-case-pharma.064f903275":"Not aspirational","use-case-pharma.aed3b8c6a7":"Verified","use-case-pharma.ed0ff2382e":"No rounding error crosses the unit-of-last-place threshold.","use-case-pharma.aadefaf8ed":"Correctly rounded","use-case-pharma.cc376f246e":"Corners and ranges exercised automatically in CI.","use-case-pharma.e02eea5453":"Property tests","use-case-pharma.a24d9583df":"Each result compared to a high-precision reference.","use-case-pharma.47909e2975":"256-bit oracle","use-case-pharma.4ac72fd74a":"Bounded iteration count, no floating-point unit.","use-case-pharma.97dab07ad3":"CORDIC compute","use-case-pharma.b9a7f2f458":"How the bound is proven","use-case-pharma.dc0507035e":"VERIFICATION","use-case-pharma.481d3e216b":"PROPERTY TESTED","use-case-pharma.fdd71ee1c4":"MPFR 256-BIT","use-case-pharma.51ab88da6e":"0 ULP","use-case-pharma.5aad9b2acf":"Every numerical computation in the assay and stability path is verified against MPFR at 256-bit precision. The published result is 0 ULP, correctly rounded across the documented input domain, with property-based tests driving the corners on every release. A bound asserted in the test suite on every release is worth more than a bound promised in prose, and CI exercises the corners automatically.","use-case-pharma.bed4aa0e07":"checked against an oracle.","use-case-pharma.0479003b2b":"0 ULP transcendentals,","use-case-pharma.b3edefbe8a":"Verified assays","use-case-pharma.1c336bc636":"One signed view","use-case-pharma.4f53b66120":"Lab signs. Packet is the audit artefact.","use-case-pharma.9ff3f5b234":"Sign the view","use-case-pharma.3090fcc3fb":"Deterministic compute runs the assay at each timepoint.","use-case-pharma.0d45c38423":"Run the assay","use-case-pharma.dfa447c5bf":"Each timepoint records the batch and condition.","use-case-pharma.4cae8b3dc5":"Pin to batch","use-case-pharma.5cded7c1a3":"Load the ICH Q1A protocol for the product.","use-case-pharma.07476b7d57":"Pull protocol","use-case-pharma.a8c863f489":"STABILITY","use-case-pharma.7f8353457e":"PHOTO","use-case-pharma.8889e4f118":"ACCELERATED","use-case-pharma.7f4036f349":"INTERMEDIATE","use-case-pharma.f57dc2538e":"Batch stability moves through long-term, intermediate, accelerated, and photostability conditions per ICH Q1A. Every timepoint is recorded with its protocol, the lab, the operator, and the result. The replay reconstructs the exact stability profile years later. Four steps produce each timepoint: the ICH Q1A protocol for the product is loaded, the timepoint records the batch and the storage condition, deterministic compute runs the assay, and the lab signs the view. Every timepoint carries the rule that applied, the owner, and the time it was taken, so the profile can be read back years later without rebuilding it.","use-case-pharma.fb0f4e8162":"pinned to one batch.","use-case-pharma.7881b6b568":"ICH Q1A timepoints,","use-case-pharma.f83a995f97":"Stability tracking","use-case-pharma.f5d4349e08":"Full trace","use-case-pharma.3477f4d91d":"Same answer","use-case-pharma.17a22df4e0":"Managed Fabric, licensed on your hardware, or air-gapped.","use-case-pharma.65cfa78989":"Sovereign","use-case-pharma.e56a362553":"OpenAPI 3.1 spec, typed errors (RFC 7807).","use-case-pharma.cb885a925a":"REST + gRPC","use-case-pharma.716836f719":"Assay source, method, QP, signature.","use-case-pharma.0788e3e212":"Signed packet","use-case-pharma.6cbcecba9f":"Same input, same output, every machine, every release.","use-case-pharma.02ae1c41fe":"Exact replay","use-case-pharma.0753940ae7":"Four properties","use-case-pharma.06ebfec4be":"WHAT IT GIVES YOU","use-case-pharma.41ce521083":"Every dose-response analysis, exposure-response model, and interim look runs on a deterministic engine. Bit-exact replay across machines and releases. The same curve on the trial sponsor laptop, the CRO server, and the EMA submission. The packet carries the assay source, the validated method, the QP and the signature, and the same four properties hold whether the analysis runs on the sponsor laptop, on the CRO server, or in the submission the inspector opens.","use-case-pharma.6337338005":"Dose-response curves,","use-case-pharma.94f7c5721b":"Clinical trial analytics","use-case-pharma.93cb63dfda":"You do not need to fight a chat box to question a medicine. The packet is in plain\n            language and the QP, the batch, and the assay are named.","use-case-pharma.97f604c256":"Pharma, consumer","use-case-pharma.c605f28db5":"On the record","use-case-pharma.c6fd418316":"Your medicine","use-case-pharma.8000b95afb":"Same packet the QP and EMA see.","use-case-pharma.1c54132b8e":"Record","use-case-pharma.b80e3ee8c2":"Yellow Card direct to the EMA.","use-case-pharma.67b9b8a57f":"EMA","use-case-pharma.9bed510400":"Anonymous","use-case-pharma.d6d7813c38":"Your doctor can flag a suspected AE.","use-case-pharma.e2a84ab0e8":"Doctor","use-case-pharma.75f527181b":"Free","use-case-pharma.2b28990412":"Your pharmacist can request the release record.","use-case-pharma.869aa56da8":"Pharmacist","use-case-pharma.75e6a088a0":"Four routes","use-case-pharma.bc3e09058f":"YOUR PATHS","use-case-pharma.aa288b61b9":"AE REPORT","use-case-pharma.f224db3467":"PHARMACIST","use-case-pharma.5bfded7d7e":"Every batch release is appealable. The same record the QP signed is the record you can question through your pharmacist or doctor. If you have an adverse event, the report flows into the same packet the EMA reviews. There are four routes: your pharmacist can request the release record, your doctor can flag a suspected adverse event, a Yellow Card goes direct to the EMA, and the record itself is the same packet the QP and the EMA see.","use-case-pharma.00e559085f":"can question.","use-case-pharma.0462d8f1ff":"A medicine you","use-case-pharma.281c752730":"Your right to review","use-case-pharma.11234a16b5":"One record","use-case-pharma.b855b4e2ce":"One event","use-case-pharma.53bc852024":"PSUR contribution signed and filed.","use-case-pharma.ee45c30326":"Report","use-case-pharma.5555b08203":"Causality assessed with named reviewer.","use-case-pharma.6cc845e6bf":"Causality","use-case-pharma.ebd99bac8c":"Seriousness classified per ICH E2A rule.","use-case-pharma.013ec284ee":"Triage","use-case-pharma.38337f6e72":"AE report received in E2B format, attached to the packet.","use-case-pharma.d9e7bddeb5":"Intake","use-case-pharma.92f5fe6952":"Four outcomes","use-case-pharma.a76f8ee287":"HOW IT WORKS","use-case-pharma.b08ae80666":"PSUR","use-case-pharma.1eea1c4629":"CAUSALITY","use-case-pharma.00e16bf618":"TRIAGE","use-case-pharma.871dab7bde":"INTAKE","use-case-pharma.08dfb9f1b7":"An adverse event report is no longer a black box. The intake, seriousness classification, causality assessment, and PSUR contribution each have a named reviewer, a timestamp, and a rule attached. The report arrives in E2B format and is attached to the packet, seriousness is classified against the ICH E2A rule, causality is assessed by a named reviewer, and the PSUR contribution is signed and filed. It is a case with four states rather than a form that disappears.","use-case-pharma.08beb1ad68":"with its reasons attached.","use-case-pharma.10d6254d2e":"A report moves","use-case-pharma.c3abe6a2f7":"How adverse events are handled","use-case-pharma.1f548147d1":"Adverse events reviewed.","use-case-pharma.993a665d35":"In charge","use-case-pharma.905cb326c7":"You","use-case-pharma.4d73d375e8":"Built and run under EU rules.","use-case-pharma.ef5fdf226f":"Footing","use-case-pharma.c82d1b09cf":"EU","use-case-pharma.326b498de3":"The batch that shipped your pack.","use-case-pharma.8e16e5b2c4":"Real","use-case-pharma.1641a6eed5":"A reason, not a guess.","use-case-pharma.89b86ab0e6":"Language","use-case-pharma.34118050b2":"Plain","use-case-pharma.add13156bd":"When your pharmacy runs on Dweve","use-case-pharma.f31727ff20":"WHAT YOU GET","use-case-pharma.f61bd3b50c":"EU RULES","use-case-pharma.bf30528228":"NAMED QP","use-case-pharma.b838c172bb":"PLAIN LANGUAGE","use-case-pharma.6d8bfe11c1":"When your pharmacy uses Dweve, your medicine is not a black box. It is tied to a released batch, an assay result, and a named qualified person who signed the release. If you ask why, the answer is on the leaflet. Four things come with it: plain language, the batch that shipped your pack, the qualified person who released it by name, and an adverse event review that happens every six months.","use-case-pharma.6dfc6de514":"can read.","use-case-pharma.404ad752f9":"Your side of the medicine","use-case-pharma.ea298ad88d":"The trial, the release, and the post-market surveillance all draw from one packet\n            source. The EMA inspector opens one file per decision.","use-case-pharma.9d4bb4692d":"Pharma, business","use-case-pharma.9030bbe906":"One signed record","use-case-pharma.90efc21e83":"Four stages","use-case-pharma.0c6395ec8c":"Protocol amendment signed, IRB notified.","use-case-pharma.b989269017":"Amend","use-case-pharma.966513b8fc":"AE monitored, E2B format attached.","use-case-pharma.ec0f106980":"Monitor","use-case-pharma.7b70e9343f":"Dose administered, batch and rule recorded.","use-case-pharma.da7f99e8cb":"Dose","use-case-pharma.c5a618269a":"Subject enrolled, eligibility rule pinned.","use-case-pharma.050a944c66":"Enrol","use-case-pharma.1266d10028":"CLINICAL OPS","use-case-pharma.66426f4968":"AMEND","use-case-pharma.c1e94b2615":"AE","use-case-pharma.fcb345bbba":"DOSE","use-case-pharma.f14d652291":"ENROL","use-case-pharma.2d4d3d5dce":"Clinical operations is the workflow most damaged by EDC, CTMS, and eTMF systems that were never meant to agree. Dweve wraps the trial in a deterministic decision layer so every enrolment, every dose, every adverse event, and every protocol amendment sits in the same packet the QP signs at release. Four stages land in it: a subject is enrolled with the eligibility rule pinned, a dose is administered with its batch and rule recorded, an adverse event is monitored in E2B format, and a protocol amendment is signed with the IRB notified. The trial, the release, and post-market surveillance then read from one packet source.","use-case-pharma.a365ca37d3":"from the same packets.","use-case-pharma.6ecd28619a":"A trial reads","use-case-pharma.9137b7e54c":"Clinical operations","use-case-pharma.4e9899fb4f":"The release decision stays inside your jurisdiction. The same platform scales from\n            a single pilot trial to a full commercial manufacturing pipeline without re-platforming.","use-case-pharma.46f92ea598":"Your control","use-case-pharma.da05ae7756":"Run on GxP-qualified servers in your data centre. Same API, same trace format.","use-case-pharma.0058df0a6e":"Dweve-operated public Mesh; processing boundary documented in the agreement.","use-case-pharma.f62d4734d1":"GxP QUALIFIED","use-case-pharma.67b752639a":"MANAGED MESH","use-case-pharma.83007fc191":"Two questions decide procurement: where does it run, and which rules does it satisfy. It runs managed through Fabric on the public Dweve Mesh, on your GxP-qualified hardware, or fully air-gapped, with no re-platforming between tiers. GDPR, GxP, 21 CFR Part 11, and the EU AI Act are design constraints the platform satisfies by construction.","use-case-pharma.3fb9f3f8b5":"Run on your hardware.","use-case-pharma.560486613b":"Start with the managed service.","use-case-pharma.1d197d39c5":"Where it runs","use-case-pharma.45bb7a2dbf":"Under a minute","use-case-pharma.c0f85d6679":"Replay","use-case-pharma.e7435a083b":"Opaque releases","use-case-pharma.f68cece41b":"Trace attached","use-case-pharma.827d4974d5":"Signed packet the inspector replays in under a minute","use-case-pharma.4e250b4fde":"REPLAY","use-case-pharma.f86a7c6e4e":"QP Dr. A. Jansen, signature, timestamp","use-case-pharma.501e489055":"OWNER","use-case-pharma.10be3da367":"Validated HPLC method, version 2024-v3","use-case-pharma.098632eb27":"METHOD","use-case-pharma.44398d07b2":"Assay run, raw chromatogram, integration parameters","use-case-pharma.e9ae0ed784":"SOURCE","use-case-pharma.75893b4f4d":"QP-signoff-2026-06-12.pdf","use-case-pharma.4882e10dfa":"spec-EU-1-90-036.pdf","use-case-pharma.728ef9e399":"method-HPLC-2024-v3.pdf","use-case-pharma.d7f0270a72":"Validated method HPLC-2024-v3 (ICH Q2 R2 compliant) measured the cetirizine assay at 99.4 percent, within the registered spec of 95.0 to 105.0. The batch passed dissolution, related substances, and identification tests per the marketing authorisation EU/1/90/036. The qualified person Dr. A. Jansen signed the release on 2026-06-12. The same decision replays bit-identical.","use-case-pharma.7f4a184ece":"THE RECORD SHOWS","use-case-pharma.4761c41eaf":"Why was batch 4f9e released with assay 99.4%?","use-case-pharma.6d952af342":"THE INSPECTOR ASKS","use-case-pharma.ba12c1d424":"The release packet","use-case-pharma.182d7e036e":"Every batch release, dose-response analysis, and stability timepoint leaves a signed packet: the assay source, the validated method, the QP, and a bit-exact replay. The inspector opens one file and watches the same decision come back. The source is the assay run with its raw chromatogram and integration parameters, the method is the validated one at its exact version, and the owner is the QP who signed with a timestamp. One file per decision, assembled as the work happens.","use-case-pharma.e0a875d0f4":"The packet the inspector","use-case-pharma.c4b73a90a0":"The assay is the easy part. Reconstructing the why of every batch release six\n              months later, in front of an EMA inspector, is the hard part.","use-case-pharma.e05e55ea6f":"Each blocks release","use-case-pharma.ec95d99629":"Four gaps","use-case-pharma.e10fad6d31":"A chat log does not replay the same way twice.","use-case-pharma.fade4edeec":"No evidence","use-case-pharma.04bf55bd68":"Foreign-hosted trial data fails the GDPR + GxP rules.","use-case-pharma.e03947cc0c":"Sovereignty","use-case-pharma.a6495e76db":"A score is not a release decision a QP can sign.","use-case-pharma.8479f2b690":"Black box","use-case-pharma.42babb2534":"It invents a result instead of citing the validated method.","use-case-pharma.a978d8e92c":"Hallucination","use-case-pharma.782cef5501":"Four structural gaps","use-case-pharma.ad1fd42972":"WHY GENERIC AI FAILS THE INSPECTION","use-case-pharma.1d47928c7f":"QP SIGN-OFF","use-case-pharma.4dcaccd5cc":"ASSAY","use-case-pharma.f73b278fda":"RELEASE","use-case-pharma.df6e06db09":"A head of quality does not buy a platform. She survives an inspection. EMA GxP rules, 21 CFR Part 11, and the EU AI Act each want the same thing: the batch, the assay, the rule, the qualified person, and the signature of every release decision. Today that record lives in LIMS, ERP, QMS, and email threads that were never meant to agree.","use-case-pharma.da04c5c020":"show the EMA.","use-case-pharma.e8bde584a5":"A batch you can","use-case-pharma.ffe3cc2823":"The release decision","use-case-pharma.a4fb970cd2":"See where it runs","use-case-pharma.654bc71af3":"Talk to a pharma engineer","use-case-pharma.26ef624776":"Pick one workflow: batch release, dose-response analysis, stability tracking, or pharmacovigilance triage. Run it with your own assay data and watch the review packet assemble as the work moves. Managed through Fabric on the public Dweve Mesh, on your hardware, or air-gapped.","use-case-pharma.e7741d8c86":"Start with the decision you most dread explaining to an inspector.","use-case-pharma.d75a4de2ef":"EU AI Act","use-case-pharma.22ed2a78d2":"ICH Q1A","use-case-pharma.05823f7512":"ICH E2B","use-case-pharma.1fba16c86f":"21 CFR Part 11","use-case-pharma.d4ff2abf6a":"Dose-response curves","use-case-pharma.e0f003eeea":"Bit-exact replay for dose-response, batch stability, and pharmacovigilance triage. 21 CFR Part 11 compliant signatures, ICH E2B aware, EU-sovereign. Integrate via API, host in the EU, or run air-gapped for the most sensitive trial data.","use-case-pharma.f1515a65b5":"Keep the signature chain.","use-case-pharma.6484f4d830":"Replay the calculation.","use-case-pharma.1106225e24":"Your medicine card","use-case-pharma.8ac76e4c2d":"A medicine reaches you through a chain of checks. Dweve keeps the released batch, test result, and person who signed the release together, so the explanation does not disappear inside a system you cannot inspect.","use-case-pharma.3b4172ef14":"behind your medicine.","use-case-pharma.8ce14944bc":"See the record","use-case-pharma.1205c3c8d5":"See a release packet","use-case-pharma.68b05662cb":"Keep the batch, assay, governing rule, qualified person, and model version together at release. The GxP-validated decision record is ready for an EMA inspection, FDA 483 response, or PSUR cycle, without rebuilding it after the fact.","use-case-pharma.ac9e85ab0d":"Retain the full record.","use-case-pharma.370e1c03ba":"Release the batch.","use-case-pharma.9d0eb0a33d":"Adverse events reviewed every six months","use-case-pharma.7b8ddb90f8":"REPORT","use-case-pharma.773a836e14":"EU, marketing authorisation EU/1/90/036","use-case-pharma.eb8d72238c":"JURISDICTION","use-case-pharma.b4e83ceb4e":"Dr. A. Jansen, named qualified person","use-case-pharma.f6bce2f910":"RELEASED BY","use-case-pharma.d167afeba4":"99.4% assay, within the 95 to 105 percent spec","use-case-pharma.fb7c2e80ac":"QUALITY","use-case-pharma.2127f80416":"tablet, batch 4f9e","use-case-pharma.aada53c069":"Cetirizine 10mg","use-case-pharma.964bd5656c":"PRODUCT","use-case-pharma.47b52c89f1":"RELEASED / EMA","use-case-pharma.e5522cd210":"Your medicine, on the record","use-case-pharma.eed7e4b1c2":"Replay pulls the full sequence back","use-case-pharma.ea9d1aef67":"Each step has a named reviewer and a timestamp","use-case-pharma.506ce7f0e9":"Adverse event triage, on the record","use-case-pharma.a2e52a1bce":"Causality assessment with rule and reviewer.","use-case-pharma.51f9cdbb0b":"Seriousness classified per ICH E2A.","use-case-pharma.988ce77705":"AE report received, E2B format attached.","use-case-pharma.fd4fd931b4":"Replay reconstructs the same stability curve","use-case-pharma.8d178cb280":"Each timepoint logged with rule, owner, timestamp","use-case-pharma.d4394e23e7":"batch 4f9e / 24-month view","use-case-pharma.3d51325ef7":"Batch stability, ICH Q1A","use-case-pharma.5047541d94":"99% potency","use-case-pharma.6351344f47":"Photostability (ICH Q1B)","use-case-pharma.e0082ee47d":"88% potency","use-case-pharma.fc07287572":"Accelerated (6 months)","use-case-pharma.d28381d994":"92% potency","use-case-pharma.4b651a9303":"Intermediate (12 months)","use-case-pharma.a19efbd082":"96% potency","use-case-pharma.6e22e0bd56":"Long term (24 months)","use-case-pharma.11dc9e1952":"Status:","use-case-pharma.6733bb8acc":"EMA safety report, all sources compiled.","use-case-pharma.19786ca4d2":"Periodic Safety Update","use-case-pharma.9009338880":"Final application for market authorisation.","use-case-pharma.8924a20ea0":"New Drug / Marketing Auth.","use-case-pharma.3441e3ce3f":"EMA national submission for trials in EU.","use-case-pharma.3265d0f5b5":"Clinical Trial Authorisation","use-case-pharma.39ca7b304b":"FDA submission to begin human trials.","use-case-pharma.a9690c0342":"Investigational New Drug","use-case-pharma.d80aa7b38f":"Replay reconstructs the exact figure","use-case-pharma.a99dcd0471":"Same curve on every machine, every release","use-case-pharma.9ae2df62e8":"Replay bit-identical","use-case-pharma.42cf567a79":"Placebo baseline","use-case-pharma.55226ce0a0":"Response rate (active)","use-case-pharma.0f0132aa95":"Cetirizine / n=412 / EMA PSUR","use-case-pharma.cef04e2756":"Dose-response, phase II","use-case-pharma.6499042440":"SIGNED / SEALED / REPLAYABLE","use-case-pharma.127edee78d":"SIGNED","use-case-pharma.4b6450db6e":"Dr. A. Jansen, qualified person","use-case-pharma.75125310a7":"QP","use-case-pharma.bd564db5d5":"PASS","use-case-pharma.d3bb81622e":"99.4% (spec 95.0-105.0)","use-case-pharma.9301bebd5f":"RELEASED","use-case-pharma.8614c27847":"4f9e, 124,000 units","use-case-pharma.b6cca12605":"BATCH","use-case-pharma.cdeb528df2":"Cetirizine 10mg tablet","use-case-pharma.77f1dcc66e":"batch 4f9e / release","use-case-pharma.9113bc47de":"CERTIFICATE OF ANALYSIS","use-case-pharma.ab090d89cd":"GxP","use-case-pharma.fbcec86144":"Business Workspace","use-case-pharma.c73cc64719":"Air-gap","use-case-pharma.1dabba21cd":"✓","use-case-pharma.869360a6f4":"Bit","use-case-pharma.c8e5998f6a":"API","use-case-pharma.9170a8b2fb":"EU","use-case-pharma.2876814bd7":"Integer","use-case-pharma.adbc560c32":"MPFR","use-case-pharma.f23ba2a6ee":"proptest","use-case-pharma.be258ce66f":"0 ULP","use-case-pharma.5d0b2f6bd4":"OBSERVED","use-case-pharma.feb892b2eb":"DEPLOYMENT","use-case-pharma.d072aa117d":"WORKFLOW","use-case-pharma.0a935ec18c":"PATIENT","use-case-pharma.fcbe85ee9b":"PHARMACOVIGILANCE","use-case-pharma.6f38f66d9a":"PLATFORM","use-case-pharma.39bda14904":"EVERY RELEASE","use-case-pharma.5ce41bc339":"ARCHITECTURE","use-case-pharma.46b9927e1d":"DETERMINISM","use-case-pharma.stability.profile":"Long-term profile","use-case-pharma.stability.limit":"Release limit","use-case-pharma.stability.batch":"Batch","use-case-pharma.stability.protocol":"Protocol","use-case-pharma.stability.owner":"Record owner","use-case-pharma.stability.lab":"Stability lab","use-case-pharma.stability.outcome":"Outcome","use-case-pharma.stability.within":"Within protocol","use-case-pharma.stability.condition":"Storage condition","use-case-pharma.stability.timepoints":"Recorded timepoints","use-case-pharma.stability.latest":"Latest result","use-case-pharma.stability.state":"Series state","use-case-pharma.stability.complete":"Complete","use-case-pharma.trace.accent":"replays in under a minute","use-case-pharma.d440a61b46":"A qualified person signs a release once. The record of why has to be readable six months later.","use-case-pharma.ee3c19427f":"The inspector's question and the record's answer are two halves of one artefact.","use-case-pharma.ad8132bfa7":"What the answer was assembled from","use-case-pharma.a29c422e91":"The boundary around the deployment moves. The runtime inside it does not.","use-case-pharma.66e460026d":"No re-platforming between tiers","use-case-pharma.c0dcf41745":"Enrolment, dose, adverse event and amendment all land in the packet the qualified person signs.","use-case-pharma.096a0b20b8":"The record behind a packet of tablets is short, and it names a person.","use-case-pharma.55f7a3261a":"A side effect report is a case with four states, not a form that disappears.","use-case-pharma.796e4bebf1":"Asking about your medicine should not depend on which door you happen to knock on.","use-case-pharma.85475239fb":"A dose-response figure is only evidence if the same run reproduces it.","use-case-pharma.c63e927f3f":"Every stability timepoint carries the rule that applied, the owner and the time it was taken.","use-case-pharma.fc149d0201":"A bound asserted in the test suite on every release is worth more than a bound promised in prose.","use-case-pharma.04dc9410f1":"Where the processing boundary sits is a procurement question. What runs inside it is not.","use-case-pharma.2047c93bb2":"The signed signal feeds the next ingest","use-case-pharma.eaaf8813e0":"Signal scoring pinned to a model version ships the same flag every time it is run.","use-case-pharma.afae68c370":"The packet is the audit artefact. It is written as the release happens, not rebuilt from logs afterwards.","use-case-pharma.2c77216fad":"The systems of record keep working. The decision layer records why the release happened.","use-case-pharma.b5a1c78fca":"Deployment postures against what stays the same","use-case-pharma.951da009a0":"One typed surface, three postures, and the same replay packets out of all of them.","use-case-pharma.d53be98acc":"One file per decision","use-case-pharma.ca2307fff0":"Assembled as it happens","use-case-pharma.ca66862dfe":"The active response track plotted against the placebo baseline","use-case-pharma.398ba6adef":"2.5 to 40mg","use-case-pharma.d4c2cece29":"The filings one medicine accumulates","use-case-pharma.da9e5b7250":"Four regulatory artefacts drawn from the same packets","use-case-pharma.4bea6682b5":"Drawn from packets","use-case-pharma.fc9e3cc934":"four filings","use-case-pharma.ae74f8cd67":"Each filing shows the state it is actually in.","use-case-pharma.5e47146d99":"How one adverse event report moves through four states","use-case-pharma.e5fbfa7fdc":"Four states","use-case-pharma.04c942610b":"one case, four states","use-case-pharma.c7dd1721b7":"The state a case is in stays visible while it is still open.","use-case-pharma.d1d1f334ac":"The five fields the record behind one packet of tablets holds","use-case-pharma.35d9bc5159":"Released","use-case-pharma.0ac805be1a":"five fields","use-case-pharma.cba72bf8e7":"The qualified person, the batch and the assay are named.","use-case-pharma.c43128b2c2":"What the inspector asked and what the record answered","use-case-pharma.6e3665d85f":"Signed","use-case-pharma.5c7f123718":"four lines","use-case-pharma.63e5c496da":"One question, one file, and the same answer every time it is opened.","use-case-pharma.95ca31099a":"One platform, three perimeters","use-case-pharma.8740faed1e":"Where the processing boundary sits in each posture","use-case-pharma.ed43e3f0e0":"Same runtime","use-case-pharma.89ecc13361":"three postures","use-case-pharma.0ad0c22bc6":"Same API and same trace format in all three.","use-case-pharma.3f97634cc3":"Four trial events, one packet","use-case-pharma.d1cc9e3ce6":"What each clinical event deposits in the record","use-case-pharma.7b382f8c6d":"four fields","use-case-pharma.c236353998":"The trial, the release and the surveillance draw from one source.","use-case-pharma.96cc616ebb":"Three ways to ask, one record","use-case-pharma.5c9b9f3ec0":"Where each of the three routes arrives","use-case-pharma.76275e2fe5":"Same record","use-case-pharma.178e97b8d4":"three entrances","use-case-pharma.d1e1bdbda9":"The answer does not change with the door you came in through.","use-case-pharma.7eac05b523":"CPU-NATIVE","use-case-pharma.3d6743aedf":"LONG-TERM","use-case-pharma.a1a27ef897":"CI-GUARDED","use-case-pharma.51c601c90f":"GxP"}