AI-native GMP compliance
Qualiva turns scattered documents and manual checks into one verified readiness verdict — guiding pharmaceutical manufacturers to GMP compliance against WHO, EU GMP, and Annex 1. In Arabic and English.
GMP Readiness Verdict
Computed by deterministic logic — defensible in an inspection, never an AI guess.
One verified verdict
Every readiness figure Qualiva shows is computed by deterministic, traceable logic — grounded in your own documents and operations. The AI interprets and guides; it never invents the verdict.
One number you can defend in front of an inspector, not five dashboards that disagree.
How the verdict is computed
Readiness = 60% document coverage
+ 40% operational readiness
open critical or major findings
cap the band.
The platform
From a factory with zero documentation to a compliant, inspection-ready QMS — guided every step, with smart defaults and no dead ends.
Controlled documents, versioning, and PIN-based e-signatures — fully Annex 11 / Part 11-aligned.
Capture, investigate, and link — with AI-grounded root cause and corrective actions.
One continuous readiness verdict across the six GMP domains, with guided gap closure.
Paper-on-glass or full electronic BMR, with context-aware links to every related record.
The Annex 1 suite — aseptic process, contamination control strategy, and validation.
An always-on GMP intelligence that guides a factory from zero documentation to compliance.
Pricing
Annual plans are billed at ten months for twelve. No free tier — Qualiva is a production compliance system, not a trial toy.
Core QMS, document control, deviations & CAPA, and Ask Qualiva.
Request accessEverything in Pro, plus the full EU GMP & Annex 11 readiness pathway.
Request accessEverything in EU GMP, plus the Annex 1 sterile suite & validation.
Request accessRequest access and we'll set up your factory — guided from day one.
Request access