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Bilingual Arabic/English floor execution, 100% sovereign data residency, and greenfield fast-track GAMP 5 CSV validation
As the Kingdom of Saudi Arabia advances Vision 2030 through the Riyadh Pharma Valley and the UAE accelerates domestic life sciences manufacturing across Dubai Science Park and Abu Dhabi, regional pharmaceutical plants require strict SFDA and UAE MoHAP compliance, sovereign in-country data residency, and real-time bilingual (Arabic/English) shop-floor execution. Novaqis unifies eBR, eLog, LIMS, and QMS on a single validated data fabric with zero per-operator seat taxes.
Technical Architecture
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Real-time dual-language interface switching for multi-national floor operators: executes Master Batch Records, equipment logbooks, and SOP reading verification in Arabic and English simultaneously.
Full compliance with Saudi National Data Management Office (NDMO) and UAE Federal Decree-Law on Data Protection: deploy 100% air-gapped on-premises or within local sovereign cloud VPCs (AWS Bahrain/UAE, Oracle Cloud Riyadh).
Pre-configured regulatory controls aligned with SFDA GMP guidelines, WHO Good Manufacturing Practices, and US FDA 21 CFR Part 11: cryptographic audit trails and instant Inspection Room Mode dossier generation.
Pre-executed GAMP 5 Category 4 validation packages and turn-key IQ/OQ/PQ execution packs designed to accelerate greenfield plant licensing in Saudi industrial clusters and UAE free zones.
Compliance & control
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
Native RTL (Right-to-Left) and LTR interface support with bi-lingual batch record PDF rendering.
Zero cross-border data transfer; offline ES256 asymmetric cryptographic licensing tokens.
Pre-flight batch genealogy and lot issuance aligned with Saudi Drug Tracking System (RSD / Wasfaty).
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Achieve 100% data residency compliance inside Saudi Arabia or UAE borders with air-gapped hosting
Empower localized and expatriate shop-floor workforces with dual Arabic/English operational interfaces
Accelerate greenfield facility commercial licensing under SFDA and MoHAP by 6+ months
Scale across operators and analysts with predictable Enterprise Site Licensing ($0 per-user seat tax)
FAQ
