Industry

Pharma & Life Sciences

Validated, compliant digital solutions for regulated pharmaceutical manufacturing

21 CFR
Part 11 Compliant
100%
Batch Traceability
Zero
Cloud Dependency
<5ms
Edge Inference
Overview

Pharma & Life Sciences — Digital Transformation

Pharmaceutical manufacturing demands the highest standards of quality, compliance and traceability — every deviation, every batch parameter, every equipment reading must be captured in a validated, tamper-evident system. Delfers delivers fully GxP-compliant industrial intelligence from cleanroom IoT and edge AI to LIMS integration and serialisation.

Key Challenges
Achieve GxP compliance for all computerised systems (21 CFR, Annex 11, GAMP 5)
Deploy IoT and AI inside cleanrooms with zero cloud dependency
Automate batch traceability and deviation management
Meet serialisation requirements (DSCSA, EU FMD, WHO PQ)
Solutions

Industry-Specific Offerings

Production-grade solutions tailored to the real operational demands of pharma.

GxP-Compliant Edge AI

Far-edge AI inside classified cleanrooms — complete audit trails, electronic signatures, 21 CFR Part 11 compliance. Zero cloud dependency.

21 CFR Part 11EU Annex 11Audit TrailFar-Edge AI
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LIMS & Batch Traceability

LIMS integration with ERP, MES and QMS for end-to-end batch genealogy, sample tracking, COA generation and electronic batch records.

LIMS IntegrationeBRBatch GenealogyCOA Automation
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Computer Vision QC

100% automated tablet inspection, packaging integrity, fill-level verification and label accuracy — replacing manual QC at full line speed.

Tablet InspectionFill Level AILabel VerifyValidated Output
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Projects

Industrial Use-Cases & Deployments

Real deployments. Measurable outcomes. Proven in production.

Cleanroom Edge AI — Global Pharma

Far-edge AI inside Grade B/C cleanrooms for computer vision QC — 21 CFR Part 11 compliant, <5ms inference, GAMP 5 validated. Zero cloud.GxP compliant · <5ms · GAMP 5

EU FMD & DSCSA Serialisation

Serialisation and track-and-trace across 6 packaging lines — EU FMD, DSCSA and WHO PQ compliant from production to pharmacy.6 lines · EU FMD · DSCSA · WHO PQ

MES & LIMS Integration — Biotech

Full MES with eBR, weigh & dispense and LIMS integration — batch release reduced from 14 to 4 days through automated CAPA.14 → 4 day release · eBR · Automated CAPA
Client Highlight
"Far-edge AI inside GxP cleanroom — 21 CFR Part 11 compliant, <5ms inference, full GAMP 5 validation. Zero cloud."

Schedule a Product Demo

See how Delfers can automate and enhance your pharma operational efficiencies.

Operate Optimally
Maintain Reliably
Assure Quality
Manage Intelligently
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Ready to Transform Your Pharma Operations?

Talk to a Delfers engineer who specialises in your sector. No generalists — just deep domain expertise.