The Unified Operating System For Life Sciences.
NevitOS brings electronic quality management and enterprise operations into one validated platform. Built for medical device, pharmaceutical, and IVD manufacturers who can't afford parallel systems, manual reconciliation, or audit surprises.
Configured for the Standards You Ship Against.
Medical Devices
Class I–III device manufacturers – design controls, DHF/DMR, UDI and post-market surveillance.
Pharmaceuticals
Drug substance and product manufacturers – batch release, deviations and EBR aligned with GMP.
In Vitro Diagnostics
IVD developers – performance evaluation, technical and lot release under IVDR and CLIA.
Biotech & CDMO
Cell, gene, and contract manufacturers – multi-client segregation with shared quality backbone.
Full-spectrum Lifecycle Management, in One Validated System.
From design controls to delivery and complaint capture – every module shares one data model, one identity layer and one audit trail. No more eQMS bolted onto a generic ERP.
Document control, CAPA, change control, deviations and complaints with automated routing and 21 CFR Part 11 e-signatures.
Schedule internal and supplier audits, capture findings, and route corrective actions straight into CAPA with a full audit trail.
Role-based training plans tied to controlled SOPs, with completion tracked and enforced before task sign-off.
Real-time stock, lot/serial genealogy, expiration and cold-chain monitoring with full GxP audit trail.
Material requirements planning linked to released BOMs, routings, and qualified suppliers.
Approved vendor list, qualification records, RFQs, and POs governed by your QMS – not parallel to it.
Pick, pack, ship with UDI, eIFU, and country-specific regulatory labelling built into every shipment.
Account, opportunity, and order management with complaint capture flowing straight back into CAPA.
Pre-executed IQ/OQ scripts, validation kits, and dashboards across quality, operations, and commercial.
Two Stacks. One Source of Truth.
Most life-sciences companies run a dedicated eQMS next to a generic ERP, then spend quarters reconciling them for audits. NevitOS removes that seam entirely.
Regulatory Assurance Built Into The Architecture.
NevitOS was designed from day one against FDA, EMA, and notified-body expectations. Pre-executed validation kits, signed audit trails, and a documented SDLC reduce time-to-compliance from quarters to weeks.
Request Validation KitReady to Consolidate Quality and Operations?
Book a 30-minute technical consultation with our validation specialists. We'll walk through your current QMS/ERP landscape and a migration path to a unified NevitOS environment.
