The quality OS for pharma manufacturers
NeoAssure brings 20 quality modules onto one GxP platform — from document control and CAPA to batch records and serialization — on 10 shared engines with a tamper-evident Proof Ledger. Inspection-ready every day, at a price an MSME can afford.
We publish this page the same way we build: honestly. The scope below is documented and reviewed, the build hasn't started — and nothing here implies live customers or completed software.
From the makers of Abhilekh — the live pharma cold-chain compliance platform. Same compliance DNA, applied to the whole factory.
Indian pharma needs a quality system it can afford
Revised Schedule M is now binding on every manufacturing unit — and the tools that can prove compliance were priced for someone else.
Schedule M is binding
India's Revised Schedule M has applied to every pharma manufacturing unit since January 2026 — and inspections show most units are not fully compliant. Units are being closed. Every manufacturer now needs a documented, data-integrity-grade quality system.
Global eQMS is priced out
International eQMS suites for small life-science teams start around $15k–35k per year; enterprise suites run $100k+, plus first-year validation costs. Indian MSME manufacturers — the majority of the country's units — are left between paper and unaffordable software.
Data integrity is the citation
Data-integrity findings appear in a large share of FDA warning letters to Indian sites. The gap isn't effort — it's tooling: paper logbooks, shared spreadsheets, and single-purpose tools that can't prove a record wasn't altered.
20 modules, one controlled operating layer
Every module inherits the same audit trail, e-signatures, workflow, notifications, reporting, custom fields, and API surface — shared engines, not per-module rebuilds.
- Document management (DMS)
- Deviations · CAPA · Change control
- Training
- Digital logbooks
- Audit & inspection (lite)
- Risk management
- Management review · PQR
- Supplier quality + portals
- Equipment & calibration
- Complaints · Recalls
- Licence register
- Inventory & lot traceability
- Warehouse management
- Electronic batch records (EBR)
- QC lab (LIMS-lite)
- Validation · Stability
- Environmental monitoring
- Pharmacovigilance (E2B)
- Serialization
Phase sequencing is provisional until the recorded delivery decisions clear — later phases are design scope, not available software. The capability brief (PDF) carries the same status labels.
10 core engines, built once
Tenancy, identity, audit, signatures, workflow, notifications, files, reporting, configuration, and AI assist — the compliance substrate every module stands on.
Proof Ledger
Hash-chained, tamper-evident audit trail anchored daily to WORM storage with RFC 3161 timestamps — the evidence spine every module writes to.
Part 11 e-signatures
One electronic-signature engine: meaning-of-signature vocabulary, step-up re-authentication, second-signer rules — shared by all 20 modules.
Workflow engine
Configurable approval routing per module — deviations, change control, training assignments — instead of hard-coded flows.
Tenancy & identity
Multi-tenant isolation with row-level security, Keycloak SSO + MFA, and role-based access designed for regulated sharing across sites and countries.
Files, reporting & notifications
Controlled documents, rendering, scheduled reports, and notification fan-out as shared services — not per-module rebuilds.
Governed AI assist
Human-in-the-loop, permission-aware assistance — generation off by default and enabled only by customer instruction, with India-resident data processing.
Designed against the failures we kept seeing
Every differentiator below answers a documented pain: siloed records, data-integrity citations, re-validation cost, per-user pricing, and shop-floor rejection.
Quality Graph
Every record links across modules — a deviation to its CAPA, a batch to its materials, a supplier to every lot — with one-click impact analysis instead of silo-by-silo retrieval during inspections.
Continuous Validation
A validation evidence package is generated with every release, aligned to GAMP 5 and consistent with FDA CSA principles — so re-validation doesn't become a five-figure annual project.
Site pricing, unlimited shop-floor users
Priced per manufacturing site with unlimited shop-floor (Lite) users — because per-user pricing is exactly what kills adoption on the floor where records are made.
Shop-floor-first UX
QR-code logbooks, large gloved-hand targets, visible labels, and Hindi/regional-language operator screens. Colour never carries meaning alone; status is always text.
No-hostage data
Full export of your records and a supplier Trust Portal — auditors and customers get direct, scoped access instead of week-long evidence hunts.
One record with Abhilekh
From the same company as Abhilekh, our pharma cold-chain monitoring platform — environmental monitoring data and the quality system speak the same compliance language.
Sequenced by dependency, published with caveats
Design & documentation
In progressThe full product is specified: module catalogue, core engines, data model, validation approach, and delivery plan — reviewed through a structured multi-stakeholder process.
Phase 0 — Foundation
PlannedFoundation build begins: core engines in reduced scope, validation pipeline, and the UI shell, under a QMS-configured development process.
Phase 1 — Schedule M core records
PlannedDMS, deviations/CAPA, change control, training, digital logbooks, and audit-lite: the first product slice, shadow-piloted with design partners before GxP go-lives.
Compliance suite → manufacturing
RoadmapRisk, management review/PQR, supplier, equipment, complaints and licences — then inventory, batch records, QC lab, validation, stability, EM, PV, and serialization.
Roadmap sequencing is provisional; dates beyond the Phase 0 start are planning targets, not commitments. We will update this page as gates clear.
Questions, answered honestly
Become a NeoAssure design partner
Early partners get their workflows designed into Phase 1, founding-customer terms, and a front place in the shadow-pilot programme — while Abhilekh's monitoring platform is ready for your rollout.