Core Engine21 CFR §11
One narrative for inspectors
Follow a document, training record, or quality event without hopping tools. AuditLens helps you plan and rehearse before the visit.
Deterministic GxPValidated Module
Solution · For QA leaders
Quality software QA leaders can defend in audit
Documents, training, deviations, and inspection readiness in one calm story
QA leaders are accountable when evidence does not connect. Novaqis keeps controlled documents, training proof, quality events, and inspection readiness on one platform, so you spend less time chasing exports and more time running a defensible quality system.
Solution TelemetryGAMP 5 Cat 4
Validation Dossier:Pre-Scripted IQ/OQ
Deployment Footprint:On-Prem / Cloud Validated
Audit Architecture:SHA-256 Chained
Per-Seat Tax:$0 (Site License)
Technical Architecture
Governed Operational Capabilities
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Regulatory Integrity21 CFR §11
Quality processes that match your SOPs
Shape deviations, CAPA, and change control to how your site already works, then keep documents and training in the same conversation.
Deterministic GxPValidated Module
System Architecture21 CFR §11
Training that proves presence
Competency evidence tied to the versions people must follow, not login timestamps and paper rosters.
Deterministic GxPValidated Module
System Architecture21 CFR §11
Holds that reach the floor
When manufacturing records are in the suite, quality decisions can matter at release, not only in a parallel tracker.
Deterministic GxPValidated Module
Enterprise Outcomes
Why Regulated Operations Standardize on Novaqis
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Fewer swivel-chair reconciliations before closure
Calmer inspection weeks
Clearer ownership across QA and the plant