For pharma plants in Boston, Basel, Cork, Hyderabad and Ahmedabad. FDA 21 CFR Part 11-ready electronic batch records, GxP-aligned MES, lab integration, serialization (DSCSA, EU FMD) and AI for batch yield, deviation triage and document intelligence.
Even in 2026 most plants still have hybrid paper / electronic batch records. Full eBMR cuts review time 60%+ and accelerates release.
Quality teams drown in deviation paperwork. AI document intelligence triages, classifies and recommends - under human review.
DSCSA in the US, EU FMD in Europe, Russian / Saudi / Indian serialization - global pharma needs unified serialization, not country-by-country point solutions.
The full digital thread from raw material to released batch is rarely real. We build that integration layer.
Corrective and preventive actions get lost in spreadsheets. Modern CAPA workflows with audit trails close issues in days, not quarters.
IoT-enabled real-time cold-chain monitoring with temperature excursion analytics is now table stakes - most plants do not have it.
FDA 21 CFR Part 11-ready eBMR, electronic signatures, audit trails, validated user-access controls. Integrated with SAP, Oracle and Siemens PCS7.
Computer vision for visual inspection of vials/tablets, NLP for deviation triage and CAPA classification, AI assistants for OOS root-cause investigations.
GS1-aligned serialization, aggregation, EPCIS reporting, multi-country tenant model. Cold-chain IoT with temperature-excursion analytics.
Connect LabWare, LIMS, MES, SAP and DCS systems into a unified digital thread - from raw material to released batch.
Multi-agent systems that draft deviation responses, classify CAPAs and surface regulatory-precedent - with full audit trails for FDA / EMA / CDSCO review.
CMMS + IIoT for cleanrooms, fillers, lyophilizers. IEC 62443-aligned OT segmentation, designed for FDA part 11 / EU GMP Annex 11 environments.
Engagement structures designed for the "Genome Valley" pharma cluster - APIs, formulations, biologics and vaccines.
GxP-aligned MES with electronic batch records - FDA 21 CFR Part 11 ready. Referenceable under NDA.
EU AI Act-aligned deviation-triage AI engagement. References under NDA on a discovery call.
Plant operations software, safety compliance, inventory optimization and utility management for Gujarat pharma + chemicals belt.
Galaxy XCover7 ruggedized-device deployment - demonstrates electronics-grade engineering rigour relevant to pharma audit environments.
Engagements aligned with SOC 2, GDPR, HIPAA, ISO 27001, FDA 21 CFR Part 11 - attestations available under NDA.
30-minute discovery call. We come prepared with two or three concrete ways we can help your specific plant, batch process or quality challenge.
Our engineering practices, validation discipline, audit trails, electronic signatures and user-access controls are designed FDA 21 CFR Part 11 / EU GMP Annex 11 / Indian Schedule M-aware. We do not "certify" your plant - that's a plant-level compliance activity - but every system we ship comes with the evidence pack your QA team needs for those audits.
Yes. We support both classical computer system validation (CSV) and the newer FDA Computer Software Assurance (CSA) approach. Risk-based validation, IQ / OQ / PQ documentation, and traceability matrices are part of standard deliverables on regulated engagements.
On PHI-aware engagements (clinical trials, patient-reported data, medical-device software) we apply HIPAA-aware controls, GDPR-resident hosting (Azure EU / OVH / Hetzner) and BAAs with hyperscalers. Specific controls evidence available under NDA.
Yes - that is the typical engagement. We rarely rip-and-replace; we integrate. LabWare LIMS, Veeva, SAP S/4HANA, Siemens PCS7, Werum PAS-X and others are within our integration scope.
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