The integration platform that doesn’t cost you a 483.
Regulated life-sciences integrations have to survive an audit on no notice.
21 CFR Part 11 e-signature lineage, DSCSA serialization,
CDISC SDTM/ADaM clinical data, GxP validated environments,
and HL7 v2 site integrations - all with the prior-state preservation and
chain-of-custody FDA, EMA, and PMDA expect.
What integration looks like inside a regulated life-sciences estate.
A config tweak is a regulated change-control event - requested, approved, executed, witnessed, and archived. The integration platform owns half that surface.
IQ, OQ, PQ for every system touching GxP data. The integration layer can’t hide behind "infrastructure" - auditors check it specifically.
DSCSA, EU FMD, Russia CRPT - each unit-level serial flows 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 coexist with separation enforced through identity, network, and audit boundaries.
Every GxP system, one backbone.
From the fill-finish line to the QC lab - the same runtime, the same validated audit trail.
Drug product & fill-finish
DSCSA and EU FMD serialization across production sites.
R&D & QC laboratories
LIMS, ELN, and instruments integrated under GxP validation.
Serialization & packaging
Aggregation and reporting for global track-and-trace.
A regulated change, with its full chain of custody.
A representative batch-release decision moving through Art2link, as the operator sees it in the audit ledger. Every action carries its prior state, reason, e-signature, and a tamper-evident hash. The document an FDA inspector asks for - produced on demand.
The regulated and commercial systems an L/S estate runs.
Manufacturing & QC · GxP
- SAP ME / DMC regulated MES
- Rockwell PharmaSuite
- Werum PAS-X regulated MES
- LabWare LIMS
- STARLIMS
- OSIsoft PI historian
Clinical & trials · CDISC
- Veeva Vault Clinical
- Medidata Rave EDC
- Oracle Clinical / RDC
- Argus Safety
- SAS Clinical
- CDISC SDTM/ADaM datasets
Supply chain & serialization · DSCSA · FMD
- SAP S/4HANA · ATTP serialization
- TraceLink network
- rfxcel · Antares Vision
- EPCIS 1.2 events
- EU Hub · NMVS verification
- GS1 GTIN / SSCC labels
The regulatory surface an integration platform owns.
Art2link runs in your Azure subscription - clinical, GxP, and PHI data never leave your tenant. GxP-validated deployment topology with IQ/OQ/PQ scripts. Audit retention configurable to FDA 21 CFR Part 211 (10+ years). EU GMP Annex 11 controls supported. Inspector read-only audit access on request.
The Art2link solutions a life-sciences estate runs day one.
System Integration
MES ↔ ERP ↔ LIMS ↔ serialization platforms. The connecting tissue between regulated and commercial estates.
Read more → PrimaryAPI Management
Partner ecosystem APIs, CRO data exchange, pharmacovigilance webhooks. OAuth 2.1, mTLS, OpenAPI 3.1 contract enforcement.
Read more → Supply chainEDI Integration
X12 / EDIFACT for raw-material suppliers, distributors, and EPCIS DSCSA serialization events.
Read more → ClinicalHL7 / FHIR Integration
For pharmacovigilance, clinical-trial site integrations, and digital-health partner data exchange.
Read more →
Walk a real regulated flow with our team.
30 minutes with a senior architect who has shipped in regulated pharma. Bring a compliance question - DSCSA, Part 11, validation strategy - or a flow to walk; leave with a tailored reference architecture.