Core Engine21 CFR §11
From recipe to completion
Master formulas drive initiation and scale. Execution carries signatures where policy needs them.
Deterministic GxPValidated Module
Solution · For manufacturing
Electronic batch work without the paper chase
Recipes, execution, clearance, and floor records connected to documents and training
Manufacturing leaders need clear runs and clean release conversations, not binders and chat threads. Novaqis BRM keeps recipes, execution, clearance, and floor logbooks on one record, connected to the documents and training the plant already trusts.
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
Right documents and ready people
Controlled-document context and operator readiness stay visible with the batch, not on a clipboard near the line.
Deterministic GxPValidated Module
System Architecture21 CFR §11
Clearance and logbooks with the story
Line clearance and electronic logbooks share the same discipline as the batch record.
Deterministic GxPValidated Module
System Architecture21 CFR §11
Quality in the release conversation
When QMS is licensed, holds can matter at release so QA and the plant share one truth.
Deterministic GxPValidated Module
Enterprise Outcomes
Why Regulated Operations Standardize on Novaqis
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Fewer late reconciliations between floor and QA
Clearer release meetings
Inspection-ready batch narratives