Loading…
Upstream/downstream batch execution, bioreactor monitoring, sterile environmental controls, and cold-chain traceability.
Biopharmaceutical and vaccine manufacturing processes involve living cells, complex purification trains, and strict sterile containment. Novaqis unifies electronic batch records (BRM), cleanroom environmental monitoring (LIMS), and document lifecycle governance (DMS) for biomanufacturing plants.
Technical Architecture
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Track seed train expansion, media preparation, bioreactor DO/pH/agitation parameters, harvest centrifugation, and chromatographic purification steps under 21 CFR Part 11 signatures.
Interactive cleanroom mapping for settle plates, viable air samplers, and contact plates with automated alert/action limit escalation directly to QMS deviations.
Monitor ultra-low freezers (-80°C) and liquid nitrogen storage with ICH Q1A stability pull calendars and automated degradation trend analysis.
Compliance & control
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
Real-time enforcement of dissolved oxygen, pH, temperature, and feed rates on shop-floor tablets.
Visual sampling grid with automated CFU counting and out-of-specification root-cause investigations.
Digital temperature logging and automated stability degradation kinetic modeling.
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Accelerated biological batch disposition via Review-by-Exception
Zero sterile cleanroom data integrity gaps during WHO & FDA audits
Complete upstream-to-downstream electronic process traceability
Enterprise site licensing for multi-building biomanufacturing campuses
FAQ
