AVIRAAH Technologies builds on-premises workflow automation software for GxP-regulated pharmaceutical manufacturers — replacing paper registers with validated, e-signature-backed digital records, without handing data to a public cloud.
Av-Orbit isn't compliant as an afterthought — every workflow, record and signature is designed against the frameworks regulated manufacturing is already held to.
Electronic records and signatures are handled to the standard's requirements for authenticity, integrity and non-repudiation.
Computerised systems are built and operated in line with Annex 11's expectations for validation, data integrity and audit trail.
Development and validation follow the risk-based, lifecycle approach to computerised systems set out in ISPE's GAMP 5 guidance.
Engineering and qualification practices draw on ISPE baseline guides for pharmaceutical facilities, systems and equipment.
Records are Attributable, Legible, Contemporaneous, Original and Accurate — enforced by system design, not policy alone.
Every workflow, e-signature and audit entry is designed to meet Good Practice expectations for regulated manufacturing.
A single platform for gate-to-dispatch compliance workflows — currently running the day-to-day operations of a regulated manufacturing site end to end.
Replacing manual registers with e-signed, audit-logged digital records across every regulated touchpoint on site — gate to dispatch, one platform, one audit trail.
The same three-step shape runs underneath every Av-Orbit module, from a gate pass to a purchase indent.
A request, entry or requisition is captured on-screen — no paper register, no duplicate re-entry.
Routed through the configured approval chain, each step captured with an e-signature, not a paper initial.
Every action lands in the audit trail automatically — nothing to reconstruct when the auditor asks.
Reporting isn't bolted on after the fact — it's one of Av-Orbit's core strengths. Every module ships with structured, print-ready reports that carry the same compliance weight as the transactions behind them, so what comes off the printer is as audit-ready as what's in the database.
Every generated report can carry a 21 CFR Part 11 e-signature, so the printed record itself is authenticated — not just the transaction behind it.
Each report's header — logo, site address, document reference — is configurable per site and per module, matching the plant's own document-control format exactly.
Visitor, Gate Pass, Vehicle (Inward/Outward), Material Movement NRGP/RGP, QC Outside Testing Samples, Item Master and Indent Requisition each ship with their own tailored report layouts — not one generic export forced across every module.
Reports can be filtered by date, status or department and generated straight from history screens — print or export, with no separate reporting tool required.
Av-Orbit is the first product to reach production. The wider suite extends the same on-premises, compliance-first approach to analytics, validation, security and infrastructure.
Enterprise compliance & workflow automation — gate pass, visitor, vehicle, item master and indent requisition, unified under one RBAC and audit model, and Individual Audit Ready E-Signed reports for every module.
End to End User Access Management workflow for user requests, approvals and execution — with analytics & reporting intelligence turning operational data already captured in Av-Orbit into management-ready dashboards and trend reports.
21 CFR & Annex 11 compliant document lifecycle management in a digital platform — drafting, multi-level review, approvals, effective, issuance, retrieval, reconciliation and archival. Audit trail and e-sign enabled.
21 CFR & Annex 11 compliant sample lifecycle management in a digital platform — analysis and results, reporting, COA, instrument usage and more.
IT infrastructure & asset management — a single register for servers, network devices and lifecycle/maintenance records.
Real-time operations monitoring — status and alerting for critical site systems, surfaced before they become compliance incidents.
Every design decision starts from how a gate, store, or QA desk actually works day to day.
Developed hands-on with the people who run gate, store and QA operations daily — not adapted from a generic template.
E-signatures, RBAC and audit logging are foundational to every module, not bolted on afterward.
Runs entirely within the site's own infrastructure — data never has to leave the building to run the business.
A built-in licensing engine lets a site enable exactly the modules it needs, and add more as it grows.
Get a walkthrough of the live platform and a straightforward view of what onboarding your site would involve.