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Swissmedic compliant, air-gapped sovereign architecture with Review-by-Exception eBR, 22-module QC LIMS, and 6-state cleanroom eLog™
From Basel's global pharma headquarters to Zurich and the BioAlps life sciences corridor, Swiss pharmaceutical manufacturers demand uncompromising precision, data sovereignty, and regulatory compliance under Swissmedic, EU GMP, and US FDA standards. Novaqis delivers a sovereign, high-performance GxP platform with offline ES256 cryptographic licensing, eliminating the risks and seat taxes of US-hosted multi-tenant clouds.
Technical Architecture
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Deploy on-premises or within dedicated Swiss private cloud infrastructure. Offline ES256 cryptographic licensing operates without external internet telemetry or unannounced cloud updates.
6-state deterministic eLog™ enforces strict cleanroom containment cascading, decontamination verification, and equipment hold-time tracking for OEB 4/5 containment.
Replaces paper master formulas with real-time CPP/CQA limit gates, automated line clearance checks, and rapid exception-only QA disposition.
Automates ASTM E29 dynamic math, volumetric solution standardization (%RSD ≤ 0.20%), column injection lockouts, and ICH stability studies.
Compliance & control
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
ES256 asymmetric token verification runs entirely offline without outbound network calls.
Dirty state in an API isolation booth automatically cascades fail-closed locks to adjacent transfer ports.
Normality factor calculation with temperature compensation and automatic expiration date lockouts.
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Guarantee absolute data residency and IP protection on Swiss soil with air-gapped deployment
Accelerate batch release from 14 days to under 4 hours via automated Review-by-Exception
Pre-executed GAMP 5 Category 4 validation packages deployed in under 60 days
Predictable enterprise site licensing with zero per-user seat tax for lab analysts and operators
FAQ
Eliminate the 12-month Computer System Validation (CSV) nightmare. Novaqis delivers pre-executed IQ/OQ protocols, automated regression test suites, and turnkey traceability matrices configured for modern life sciences.
Pre-executed verification of microservice container signatures, database schema hashes, and network isolation.
Automated regression testing of 21 CFR Part 11 e-signatures, audit log immutability, and eLog cleanroom state machines.
100% mapping of user requirements (URS) through functional specs (FS) to automated and scripted test results.
Risk-based testing classification focusing validation rigor on high-impact patient safety and product quality paths.
Request a redacted validation dossier to evaluate our GAMP 5 Category 4 evidence with your QA and CSV team.
