Industries · Pharmaceuticals

AI for the regulated floor.

Built for the batch records, the deviations, and the inspections that decide whether your next consignment ships on time.

What we recognise

A single batch generates hundreds of pages of records, deviations, and validation paperwork. Your QA team reviews them line by line. Meanwhile the next USFDA, WHO, or CDSCO inspection is always around the corner, and the last digital initiative left you with software nobody uses. We’ve seen this before. We don’t start with a transformation roadmap. We start with one painful part of your floor and make it measurably better.

What we build for you

Specific systems, deployed on your floor.

Each one scoped to your plant, integrated with your existing stack, and built to survive a regulatory inspection on day one.

01
Batch record review, automated
What it does
Reads BMRs and BPRs against SOPs and master records. Flags deviations, missing entries, and trend anomalies before QA does.
What changes
QA review cycle time drops. Recurring deviation patterns surface earlier. Batch release accelerates.
Audit trail
Every flag is logged with the rule it was checked against. Inspector can follow the lineage at audit time.
02
Deviation classification and CAPA drafting
What it does
Classifies new deviations against your historical record. Drafts CAPAs with linked precedents for your QA team to review.
What changes
Investigation time drops. Repeat deviations are surfaced. CAPA quality improves with consistent templates.
Audit trail
AI suggestion and QA decision are both stored. Auditor sees both during a review.
03
Cleaning validation analytics
What it does
Watches residue, swab, and rinse data across product changeovers. Surfaces drift before it becomes an inspection finding.
What changes
Cleaning protocols stay validated. Out-of-trend conditions are caught before the next batch is impacted.
Audit trail
Every excursion logged with the data it was based on. Validation lineage stays defensible.
04
Audit-ready document assembly
What it does
Assembles inspection packs for USFDA, WHO, CDSCO and customer audits. Pulls from MES, LIMS, and validation systems.
What changes
Inspection prep that took weeks now takes days. Your QA leads sleep before an audit, not during.
Audit trail
Every document version-controlled with electronic signatures. 21 CFR Part 11 friendly by design.
What this looks like in practice

A few examples from the work.

Illustrative scenarios drawn from the kinds of plants we know. Specific to pharma, sized like your own facility.

BATCH REVIEW
A formulation plant cuts batch review from three days to under one shift.
QA review backlog cleared. The same QA team now releases consignments on schedule, even at peak.
3× faster
Batch review cycle
Illustrative
CAPA
Deviation investigation time drops by half across a year of CAPAs.
QA leads focus on judgement, not searching the deviation log. Repeat deviations surface earlier.
-50% time
Per CAPA investigation
Illustrative
AUDIT PREP
A WHO inspection pack assembled in two days instead of two weeks.
Records were already linked, signed, and version-controlled. The inspector saw the lineage, not a binder.
7× faster
Inspection prep
Illustrative
Why we fit aerospace

Built for the rules you live under.

01
GMP-aware by design
Every output is versioned. Every decision logged. Every model traceable and explainable to a USFDA, WHO, or CDSCO inspector.
02
21 CFR Part 11 friendly
Audit trails. Electronic signatures. Validated workflows. Designed for the IT audit, not in spite of it.
03
Validated environments
On-premise installations. IQ/OQ/PQ-friendly deployment. Your CSV team can review and qualify the system the way you qualify any other.
Built around your existing stack

No replacement required.

We’ve worked with the kinds of tools aerospace shops actually run. We integrate, you keep working.

MES & LIMS
SAP
Werum PAS-X
LabWare
LabVantage
SampleManager
Instruments & data
Empower
Chromeleon
OpenLab
Historian (PI)
QMS & eDoc
TrackWise
MasterControl
Veeva Vault
Documentum
Frequently asked

In this sector.

Can the AI be validated under our CSV framework?
Yes. We design deployments to support IQ/OQ/PQ qualification. Models are versioned, validation evidence is captured, and your CSV team can review the validation package the way you review any other GxP system.
Where does our batch data live?
Wherever your IT and compliance teams require. We default to on-premise installations for pharma work. Sovereign-cloud deployment is supported. Multi-tenant cloud is not the default.
How long before we see something working?
It depends on the line, the data quality, and the use case. We don’t promise specific timelines on this page because every facility is different. What we do commit to is a written diagnosis after the first visit, with realistic estimates for your specific situation.
Do you replace our existing MES or LIMS?
No. We integrate with what you have. Replacing a validated MES or LIMS mid-cycle is exactly the kind of risk a pharma operation should not take. We build on top of your existing stack, not around it.
BASED IN
Bengaluru, India
Local presence in the same industrial cluster as your factory.
FOUNDED BY
An engineer who can explain it
A decade and more in AI engineering, plus the experience of teaching it to others.
CONFIDENTIALITY
First, not optional
NDA-friendly. Drawings, models, and data stay where they belong.
Next step

Walk us through your factory.

We’ll tell you where AI helps, where it doesn’t, and what to fix first. In writing.

Talk to us →