Novaqis - 2026 Pricing, Features, Reviews & Alternatives

Novaqis is an audit-ready GxP software platform built for pharmaceutical, biotech, sterile, and API manufacturing operations. It centralizes quality management across document control, CAPA, deviation tracking, change control, training management, and supplier qualification, delivering a unified compliance environment that supports FDA 21 CFR Part 11, EU Annex 11, and ICH Q10 requirements. Deployed in the cloud, Novaqis provides role-based access, electronic signatures, and a full audit trail across all modules, reducing reliance on paper-based processes and disconnected spreadsheets.

Novaqis is designed to scale across single-site and multi-site organizations, with configurable workflows that adapt to site-specific SOPs without requiring custom code. The platform integrates quality event management with risk assessment tools, allowing quality teams to link deviations, CAPAs, and change controls into traceable chains of evidence. Batch record review, environmental monitoring logs, and supplier audit documentation can be managed within the same system, giving quality assurance and regulatory affairs teams consolidated visibility into compliance status.

The platform supports continuous inspection readiness by maintaining structured, searchable records that can be retrieved and presented during regulatory audits without manual compilation. Novaqis also includes training management functionality that ties employee qualification records directly to document versions, ensuring that personnel are always trained on current procedures. Notification and escalation workflows keep quality events from stalling, while reporting dashboards surface open actions, overdue tasks, and quality trends across the organization.