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Pricing

Scoped to your facility.
Priced after we understand it.

StibaOS is commercial software for Indian pharmaceutical MSMEs. There is no opaque tiering — a short scoping call gets you an indicative quote for the modules and deployment you actually need.

Pilot

Single-facility pilot

For one facility evaluating StibaOS against spreadsheets and legacy QMS. Core quality and manufacturing modules, live on your own batch data.

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Enterprise

Full deployment

For multi-facility operations or regulated on-premise requirements. Every module, SSO, custom roles, and your choice of cloud or on-premise.

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What’s included

Coverage by plan

Capability areaPilotEnterprise

Batch Records (eBMR)

Electronic batch manufacturing records with in-line tolerance checks

Deviations & CAPA

Deviation lifecycle linked to root cause, CAPA, and effectiveness checks

Change Control

Impact assessment, approval workflow, and document traceability

Documents (eDMS)

Version control, approval routing, periodic review, and retention

Inspection Readiness

Gap scoring against live Schedule M sections with evidence

Audit Trail Explorer

Hash-chained, tamper-evident audit trail across every record

Training (LMS)

Role-based training plans with competency evidence

Laboratory & Stability

QC test management and stability study scheduling

Production & Equipment

Production scheduling, equipment logs, calibration status

Environmental & Digital Twin

Environmental monitoring and facility digital twin

Inventory, Suppliers & Distribution

Supply chain traceability from intake to dispatch

Audit & Regulatory Management

Audit programs and CDSCO submission traceability

KPI Dashboard & What-If Simulator

Analytics and scenario simulation across the quality system

SSO, custom roles & on-premise

SAML SSO, granular roles, and on-premise deployment

Module grouping is indicative — pilots can enable additional modules during scoping.

Built for the regulation

Mapped to Schedule M 2024, clause by clause

Every module maps to the revised Schedule M — deviations, CAPA, batch records, and audit trails — with the clause references visible in the product. Pilots include hands-on onboarding with your QA team, not just software setup.

Questions

Why is there no public per-seat price?

Pharma deployments vary by facility size, regulated product class, deployment model, and the modules you actually need. A fixed per-seat price would either over-quote a single-facility MSME or under-scope a multi-site rollout. We scope the plan to your facility and quote from there.

How does implementation work?

A pilot starts with a scoping call, then a guided walkthrough on seeded plant data mapped to your own Schedule M clauses. Your team configures roles and imports masters before running the first live batch record. Onboarding is hands-on with your QA and production leads, not a software handover.

Where does our data live?

Cloud deployments run in the AWS Mumbai (ap-south-1) region by default, keeping Customer Data in India. Tenants with strict data-sovereignty requirements can deploy on-premise on their own infrastructure, with the same compliance posture and audit-trail integrity.

Is StibaOS 21 CFR Part 11 ready?

The platform implements Part 11 technical controls: e-signatures bound cryptographically to the record they apply to, a hash-chained audit trail, signature manifestations that show signer, date, time, and meaning, and identification controls for credentials. See the Security overview for the clause-by-clause mapping.

Do you offer on-premise?

Yes. For tenants with data-sovereignty requirements or limited connectivity, StibaOS deploys on-premise on your infrastructure with the upgrade cadence agreed in your MSA.

Can we start small and expand?

That is the intended path. A pilot runs the core quality and manufacturing modules for one facility; additional modules and facilities are enabled as you grow, without re-implementing what is already live.

Ready to scope a pilot?

Tell us about your facility and current quality system. We’ll come back with an indicative scope and quote.

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