Core Engine21 CFR §11
API & Bulk Drug Synthesis Execution
Master formula execution, solvent recovery tracking, yield mass balance, and mother liquor logging engineered for Hyderabad's synthetic chemistry plants.
Deterministic GxPValidated Module
Solution · Telangana & Hyderabad Hub
Enterprise Pharma GxP Software in Hyderabad & Genome Valley | Novaqis
DMS, LIMS, LMS, QMS & EBR for Hyderabad's bulk drug, API, vaccine, and formulation corridor
Hyderabad is India's bulk drug and vaccine capital, home to world-class manufacturing across Genome Valley, Bachupally, Jeedimetla, Pashamylaram, and Patancheru. Novaqis delivers high-performance GxP digital quality operations (DMS, LIMS, LMS, QMS, and BRM) with 21 CFR Part 11 validation, sovereign on-premise installation, and transparent enterprise site licensing.
- Hyderabad Pharma Ready
- 21 CFR Part 11 Validated
- API Synthesis Focused
- Zero Seat Tax
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)
Product preview
See it in the platform
Sample tracking, instrument acquisition, and stability pull schedules
Novaqis LIMS
LIMS / Lab Dashboard
Laboratory Testing & Sample Workload Hub
21 CFR Part 11Nova AI
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
High-Throughput QC Lab Automation (Novaqis LIMS + InstrumentLink)
22-module paperless LIMS with InstrumentLink Instrument SDK for bidirectional chrom / non-chrom interlinking, USP <711> dissolution, and 2-phase OOS root-cause investigations.
Deterministic GxPValidated Module
System Architecture21 CFR §11
Sovereign On-Premises Deployment
Run 100% air-gapped on your private factory servers with offline ES256 cryptographic licensing and zero external cloud data dependency.
Deterministic GxPValidated Module
System Architecture21 CFR §11
Zero Per-Seat License Penalties
Predictable plant-wide enterprise licensing covering unlimited operators, analysts, QA reviewers, and contract staff without user seat taxes.
Deterministic GxPValidated Module
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
- API Mass Balance & Solvent Tracking
Real-time calculation of theoretical yields, solvent recovery distillation logs, and LOD parameters.
- Instrument IoT Integration
IDAS plus InstrumentLink connect HPLC, GC, balances, and other instruments for zero-transcription test recording across major LIMS.
- US FDA 21 CFR Part 11 Architecture
Dual-credential e-signatures, immutable ALCOA+ audit trails, and GAMP 5 Category 4 CSV documentation.
Enterprise Outcomes
Why Regulated Operations Standardize on Novaqis
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
100% elimination of paper batch binders and manual calculation errors
Turnkey US FDA 21 CFR Part 11 and CDSCO Schedule M compliance
Rapid 6-week plant rollout across multi-site Hyderabad manufacturing units
Dedicated local deployment and validation support
FAQ
Frequently asked questions
- Yes. Novaqis supports complete on-site deployment, CSV validation execution, and hypercare onboarding across plants in Genome Valley, Bachupally, Jeedimetla, and Patancheru.