Regulated life-sciences workloads run on integrations that have to survive an audit
on no notice. 21 CFR Part 11 e-signature lineage, DSCSA
serialization for pharma supply chain, CDISC SDTM/ADaM for clinical,
GxP validated environments, and HL7 v2 for site integrations -
all with the prior-state preservation and chain-of-custody discipline that FDA,
EMA, and PMDA expect.
A config tweak isn’t a config tweak — it’s a regulated change-control event that has to be requested, approved, executed, witnessed, and archived. The integration platform owns half the change-control surface.
IQ, OQ, PQ for every system touching GxP data. The integration layer can’t hide from validation just because it’s "infrastructure" — auditors check it specifically.
DSCSA, EU FMD, Russia CRPT — each unit-level serial has to flow through manufacturing, packaging, distribution, and dispensing with bidirectional verification at every hand-off.
CDISC SDTM/ADaM in the clinical zone. SAP / HL7 / EDI in commercial. The two estates must coexist with separation enforced through identity, network, and audit boundaries.
A representative batch-release decision moving through Art2link - rendered as the operator sees it in the audit ledger. Every action carries its prior state, its reason, the e-signature, and a tamper-evident hash. This is the document an FDA inspector asks for; we produce it on demand.
Art2link runs in your Azure subscription - clinical, GxP, and PHI data never leave your tenant. GxP-validated deployment topology (IQ/OQ/PQ scripts available). Audit retention configurable to FDA 21 CFR Part 211 (10+ years) requirements. EU GMP Annex 11 controls supported. Inspector read-only access to audit logs available on request.
MES ↔ ERP ↔ LIMS ↔ serialization platforms. The connecting tissue between regulated and commercial estates.
Read more → PrimaryPartner ecosystem APIs, CRO data exchange, pharmacovigilance webhooks. OAuth 2.1, mTLS, OpenAPI 3.1 contract enforcement.
Read more → Supply chainX12 / EDIFACT for raw-material suppliers, distributors, and EPCIS DSCSA serialization events.
Read more → ClinicalFor pharmacovigilance, clinical-trial site integrations, and digital-health partner data exchange.
Read more →A global pharmaceutical manufacturer connected 17 production sites across 6 countries for DSCSA + EU FMD serialization on Art2link - passing two FDA inspections and one EMA inspection in the first 18 months without a single 483 observation on the integration layer.
A specialty biotech consolidated 9 LIMS systems, an SAP ERP, and a Veeva QMS into one Art2link runtime - cutting the audit-trail compilation time for batch release records from 4 days to under 20 minutes.
30 minutes with a senior architect who has shipped in regulated pharma. Bring a compliance question (DSCSA, Part 11, validation strategy) or a flow you want to walk; leave with a tailored reference architecture.