Solutions
Built for how quality teams actually work
Pick a capability, a buyer role, or a region, then see how Novaqis fits without stitching five vendors into one inspection story.
Capabilities
Solution · Industry 4.0 for Life Sciences
Pharma 4.0™ Architecture & GxP IT/OT Convergence Platform
ISPE Pharma 4.0 Operating Model, Review-by-Exception eBR, Autonomous Cleanroom eLog™, and 22-Module Paperless LIMS on a Unified GxP Data Fabric
ExploreSolution · Pharmaceutical document control
Best pharmaceutical document management system for GxP teams
Pharma DMS with lifecycle control, controlled print, training gates, and inspection-ready audit trails
ExploreSolution · Document control
Document security & controlled issuance
Print, retrieval, and lifecycle controls built for GxP audit
ExploreSolution · GxP LMS & Compliance Training
GxP LMS & Pharma Employee Training Management System (21 CFR Part 11)
Universal SCORM/xAPI authoring freedom, built-in IEEE LRS, Part 11 e-signatures, and SOP retraining interlocks
ExploreServices · LIMS Migration & Automation
LIMS Migration & Worksheet Digitization (Any Major LIMS)
Assess → digitize → validate → cutover → automate — hire Novaqis for master migration on your incumbent platform or Novaqis LIMS
ExploreSolution · Quality & process design
AI-accelerated quality operations
Shape quality work to your site, and keep it connected
ExploreSolution · Manufacturing Records (EBR)
GxP Validated Electronic Batch Records (EBR) Software (21 CFR Part 11)
Step-level master formula execution, real-time limit gating, line clearance, and floor logbooks
ExploreBy industry sector
Biotech & Sterile Biomanufacturing
GxP Quality Suite for Biologics, Vaccines & Biosimilars
Upstream/downstream batch execution, bioreactor monitoring, sterile environmental controls, and cold-chain traceability.
ExploreMedTech & IVD Regulatory Compliance
ISO 13485 & FDA QMSR Quality Management for Medical Devices
Design History Files (DHF), Device Master Records (DMR), Risk Management (ISO 14971), and CAPA governance.
ExploreCRO & Bioanalytical Informatics
Bioanalytical LIMS & BA/BE Study Automation for CROs
GCP/GLP compliant sample tracking, double-blind randomization, PK calculations, and automated regulatory dossiers.
ExploreSolution · Dietary Supplements & Nutraceuticals
Nutraceutical & Dietary Supplement Manufacturing Software | 21 CFR Part 111 & NSF
Master Manufacturing Records (MMR), raw botanical testing, allergen controls, and adaptive lean e-signatures
ExploreSolution · Cosmetics & Personal Care
Cosmetics & Personal Care Formulation Software | MoCRA & ISO 22716 cGMP
Formulation lifecycle, batch manufacturing records (BMR), stability testing, adverse event logging & streamlined UX
ExploreSolution · Food & Beverage Manufacturing
Food & Beverage Quality & Traceability Software | FSMA 204, HACCP & GFSI
Critical Control Point (CCP) monitoring, automated FEFO lot tracking, sanitation logbooks & 2-hour mock recalls
ExploreSolution · Specialty Chemicals & Materials
Specialty Chemicals & Materials Manufacturing Platform | ISO 9001 & Batch Control
Reactor recipe execution, batch blending sheets, titration/viscosity testing, tank cleanout & plant CMMS
ExploreBy role
Solution · For QA leaders
Quality software QA leaders can defend in audit
Documents, training, deviations, and inspection readiness in one calm story
ExploreSolution · For validation & IT
A platform validation teams can scope with confidence
Shared identity, on-prem options, and one audit vocabulary across modules
ExploreSolution · For manufacturing
Electronic batch work without the paper chase
Recipes, execution, clearance, and floor records connected to documents and training
ExploreBy region & regulatory regime
Solution · Global Regulatory Compliance
US FDA 21 CFR Part 11 & GxP Compliance Platform
Cryptographic e-signatures, immutable ALCOA+ audit trails, and pre-validated GAMP 5 execution packs
ExploreSolution · European & International GMP
EU GMP Annex 11 & UK MHRA Compliance Software for Life Sciences
Computerized systems validation, Qualified Person (QP) batch release, and European data integrity standards
ExploreRegional Hub · Research Triangle Park (RTP) & North Carolina
North Carolina BioPharma GxP Suite · Biologics, Gene Therapy & CDMO Operations
21 CFR Part 11 electronic batch records, sterile cleanroom eLog, 22-module QC LIMS, and automated training gates for RTP life sciences manufacturers
ExploreRegional Hub · Ireland BioPharma (Dublin, Cork & Ringaskiddy)
Ireland BioPharma GxP Suite · Dual HPRA & US FDA Export Manufacturing
Unified EU Annex 11 and 21 CFR Part 11 platform: Review-by-Exception eBR, autonomous Annex 1 cleanroom eLog, and 22-module QC LIMS
ExploreRegional Hub · Switzerland BioPharma (Basel, Zurich & BioAlps)
Switzerland BioPharma GxP Suite · High-Potency API, Sterile & CDMO Platform
Swissmedic compliant, air-gapped sovereign architecture with Review-by-Exception eBR, 22-module QC LIMS, and 6-state cleanroom eLog™
ExploreSolution · India & export markets
Quality software for Indian pharmaceutical plants
Built in Vadodara for plants that serve India, and the world
ExploreSolution · 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
ExploreSolution · Gujarat Manufacturing Corridor
Enterprise Pharma GxP Software in Gujarat (Ahmedabad, Vadodara, Ankleshwar) | Novaqis
DMS, LIMS, LMS, QMS & EBR for Gujarat's formulations, API, sterile, and chemical manufacturing hub
ExploreSolution · Southeast Asia
GxP software for Southeast Asian pharmaceutical plants
One platform for regional plants serving local and export markets
ExploreRegional Hub · Middle East & GCC (UAE & Saudi Arabia)
Middle East Pharma GxP Suite · SFDA & UAE MoHAP Regulated Operations
Bilingual Arabic/English floor execution, 100% sovereign data residency, and greenfield fast-track GAMP 5 CSV validation
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