You built the EU-GMP facility. Now make the data audit-defensible.
Data-first, sovereign AI for Good Manufacturing Practice (GMP) manufacturers — India-first, engineered for the EU-GMP export gate. We fix the data integrity, integration, and operating model underneath the models — on-prem, inside your firewall, ALCOA+ by design.
The Discovery Workshop is 100% credited against your pilot · request pricing
In regulated manufacturing, the data is the risk.
AI in a GMP plant isn't a model problem — it's a data-integrity and sovereignty problem. Two forces decide whether an initiative survives contact with an auditor.
Data integrity is the export gate
Every AI output has to trace to attributable, contemporaneous, ALCOA+ data. Get the fabric right and the same evidence that trains the model passes the audit. Get it wrong and a single data-integrity finding stalls the export.
Your process IP can't leave the plant
Formulations, batch genealogy and yield data are your crown jewels — and increasingly subject to residency rules. Sovereign, on-prem deployment keeps sensitive data inside the plant walls by architecture, not policy.
Figures are published third-party benchmarks, not Cloudster outcomes. Actual results depend on baseline maturity and scope.
GxP use cases, on one sovereign fabric.
The data model comes first — so each use case deploys onto the fabric the last one built, not as another integration project.
Batch-record review by exception
Surface only the deviations that matter across electronic batch records — cutting review effort while keeping QA in the loop, on grounded, on-prem reasoning.
ALCOA+ data-integrity fabric
Unify quality and production data into one traceable, attributable record — audit-ready across LIMS, MES, historian and ERP.
Vision QC on fill & pack lines
Automated inspection for fill level, seal, label and pack integrity — every result traceable to batch, line and shift.
OEE & predictive maintenance
Predict failures on GMP lines from fused equipment and maintenance data — the recommended first pilot on your best-instrumented assets.
Don't boil the ocean. Two pilots, in order.
Because the data model comes first, the sequence is deliberate — prove the fabric on low-risk telemetry, then put the sovereign reasoning layer on top of it.
Line performance & OEE — on the line you just built
The fastest, most board-legible win protects the asset you just funded: availability, yield and downtime are numbers your board already tracks. No new floor hardware, near-zero regulatory risk — and it proves the data fabric on real production telemetry in weeks. Published pharma OEE benchmarks put recoverable hidden capacity in the range of 8–12 OEE points.
Batch-record review by exception
Once the fabric exists, the sovereign reasoning layer sits on top of it. Manual batch-record review is where export batches lose days and QA loses capacity — and where incomplete deviation linkage becomes a finding. Published batch-release benchmarks put review-time reduction in the range of 30–60%, with GMP data never leaving the firewall.
Benchmark ranges are published industry figures (SCW.ai, ISPE), not guaranteed Cloudster outcomes — actual results depend on baseline maturity and scope.
GxP-native — not a generic AI bolt-on.
- CSV / CSA-aware — validation built into delivery, not retrofitted afterwards.
- Integrates EBR, LIMS, MES, historian & ERP — no rip-and-replace.
- Sovereign, on-prem / edge — inside your firewall, residency-compliant.
- ALCOA+ by design — every output traces back to attributable data.
- Human-in-the-loop decision rights — QA approves; AI assists.
- Vendor-agnostic — best-in-class specialists, one accountable system.
A disciplined on-ramp — not a big-bang program.
Every new vertical earns its pilot. Pharma starts with a fixed-scope Discovery Workshop that de-risks the first move before you commit to a program.
Discovery Workshop
Map the highest-value, audit-defensible use case against your real data maturity. 100% credited against your pilot.
Pre-work & data-access checklist
A concrete readiness and data-access plan — so the pilot starts on solid ground, not assumptions.
Pilot SOW
A scoped, sequenced, priced pilot on the priority use case — with a CFO-ready business case.
Request pricing · ₹ ex-GST · Discovery Workshop 100% credited within 90 days.
Export-ambitious branded-formulations manufacturers preparing for — or scaling — EU-GMP supply, where a data-integrity finding is the difference between shipping and stalling.
Open the pharma conversation.
Bring your export ambition and your data reality to a Discovery Workshop — we'll map the first audit-defensible pilot, on your baseline.