Upstream & Downstream Digital Batch Records
Track seed train expansion, media preparation, bioreactor DO/pH/agitation parameters, harvest centrifugation, and chromatographic purification steps under 21 CFR Part 11 signatures.
Biotech & Sterile Biomanufacturing
GxP Quality Suite for Biologics, Vaccines & Biosimilars
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.
- Biologics Validated
- Grade A Cleanroom EM
- Cold-Chain Compliant
- 21 CFR Part 11 Ready
Capabilities
What you get
Cleanroom Grade A–D Environmental Monitoring
Interactive cleanroom mapping for settle plates, viable air samplers, and contact plates with automated alert/action limit escalation directly to QMS deviations.
Continuous Cold-Chain & Stability Testing
Monitor ultra-low freezers (-80°C) and liquid nitrogen storage with ICH Q1A stability pull calendars and automated degradation trend analysis.
Compliance & control
Built for regulated operations
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
CapabilityHow Novaqis delivers it
- Bioreactor Critical Parameter Gating
Real-time enforcement of dissolved oxygen, pH, temperature, and feed rates on shop-floor tablets.
- Sterile Cleanroom EM Mapping
Visual sampling grid with automated CFU counting and out-of-specification root-cause investigations.
- Cold-Chain Traceability
Digital temperature logging and automated stability degradation kinetic modeling.
Outcomes
Why teams choose Novaqis
- 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
Frequently asked questions
- Novaqis provides digital batch manufacturing records for upstream cell culture and downstream chromatography, automated Grade A-D cleanroom environmental monitoring, and cold-chain stability tracking on a unified GxP platform.