Regulatedoperationssoftware forpharma,biotech&GMP
Novaqis is GxP software for pharma and biotech: pharma LIMS, 21 CFR Part 11 document management, GxP QMS, electronic batch records, plus LMS, cleanroom eLog™, ERP, and HRMS on one governed stack.
Novaqis is a regulated-operations platform, not a narrow point product. Platform modules: Admin, DMS, LIMS, LMS, QMS, BRM, eLog, ERP, HRMS, AuditLens, Reporting, and Nova AI: 22-module paperless LIMS, documents, training, quality events, Dynamic eBR, cleanroom eLog™, ERP WMS & asset maintenance, HRMS payroll, audit intelligence, reporting, and Nova AI on one governed stack. Novaqis LIMS eliminates spreadsheet transcription with dynamic formula worksheets, volumetric standardization, 2-phase OOS, and SAP Usage Decision posting with zero per-seat user fees. Novaqis eLog™ enforces deterministic 6-state cleanroom containment cascading. Novaqis ERP & HRMS unify plant logistics, preventive maintenance, multi-currency payroll, and biometric rosters. AuditLens traces entities across licensed modules; server monitoring in Admin keeps infrastructure health beside identity and licensing. Fully on-premise capable. A disciplined POC shows a clear generational advantage. See for yourself.
Evaluating pharma LIMS, Part 11 document control, or the full suite? Explore Pharma 4.0 Architecture, Decision Tools, Compare, Value & TCO, or case studies.
AuditLens Sovereign Verification Dossier
Complete & Contemporaneous
ALCOA+ CompliantDr. Vikram Patel (Head of QA)
21 CFR Part 11 e-Signature100% Audit Ready
Zero Gap DiscrepanciesInteractive 3D regulated console (move cursor to tilt)
Novaqis LIMS · 22-Module Paperless Lab
Zero Seat TaxAutomated formula worksheets, volumetric titrant standardization (N1V1 = N2V2), working reference standards, 2-phase OOS investigations, ICH stability chamber calendars, Grade A/B/C/D cleanroom EM, and SAP Usage Decision posting.
Nova AI · AuditLens
Embedded across Admin, DMS, LIMS, LMS, QMS, BRM, ERP, HRMS, and AuditLens: reviewers summarize and proofread controlled content; auditors get license-scoped readiness answers; learners get comprehension checkpoints, all permission-gated and deployable on your network.
Built by teams who have operated large-scale GxP quality and document platforms for years.
Advanced GxP Technology. Fair, Transparent Economics. Zero Per-User Seat Taxes · ~50% Lower 5-Year TCO.
Novaqis is engineered for life sciences organizations that demand the most robust, high-uptime GxP architecture without the bloated multi-million dollar vendor markups of legacy monoliths. Unlimited users, multi-plant scale, and 24/7 engineering hypercare on a predictable enterprise license.
Legacy vendors penalize your growth with per-user seat fees, per-plant surcharges, and costly custom scripting. Novaqis delivers superior technology with transparent, predictable commercial terms.
Enterprise Site Licensing: Zero Per-User Seat Taxes
We do not charge restrictive per-user named seat fees ($3,000+/user/year). Enable 100% of your workforce - permanent operators, QC analysts, QA reviewers, and contractors - without budget inflation or access rationing.
Multi-Plant Scalability Without Plant Penalties
Expand across formulation units, API synthesis plants, sterile blocks, and warehouse hubs without paying incremental per-plant platform surcharges that legacy enterprise vendors routinely stack.
Unified Suite Economics vs Fragmented Vendor Sprawl
Deploying Novaqis DMS, LIMS, LMS, QMS, Dynamic eBR, eLog™, and ERP on a unified data fabric costs significantly less than buying and validating three disconnected legacy vendor tools with expensive custom API bridges.
Advanced Architecture at a Fair, Sensible Investment (~50% Lower TCO)
Novaqis delivers high-performance .NET 10 microservices, 99.99% uptime, and modern web-native workflows at roughly half the 5-year total cost of ownership of legacy vendors, delivering unmatched enterprise ROI.
Predictable AMC with 24/7 Dedicated Hypercare
Annual maintenance contracts (AMC) are transparently structured without compounding hidden escalators, including direct 24/7 access to named senior GxP software engineers and turnkey GAMP 5 validation packs.
Zero Desktop License Sprawl & Word Dependencies
Author, review, and approve controlled documents in-browser with real-time track changes, inline comments, and pantograph print security - eliminating Microsoft Word desktop subscription bloat across authoring teams.
Commercial positioning reflects typical enterprise TCO comparisons; final scope, modules, and validation services are tailored in your formal quotation. We provide transparent, predictable enterprise licensing.
Compliance
Designed for regulated environments
21 CFR Part 11
Electronic records & signatures
EU Annex 11
Computerised GMP systems
ALCOA+
Continuous data integrity
Air-Gapped
Your infra, zero phone-home
Unified Architecture
One Governed Operations Fabric
Admin is the central control plane; DMS, LIMS, LMS, QMS, Dynamic eBR, eLog™, ERP, and HRMS share identity, cryptographic licensing, and ALCOA+ audit trails without shadow databases or fragile middleware.
Control Plane
Novaqis Admin
RBAC · Cryptographic Lic · Audit
From Document Authoring to Batch Disposition
Interactive 4-stage pipeline. Every critical gate is unified on a single cryptographic data fabric.
In-Browser SOP Authoring & Redline Review
Eliminate unversioned Word attachments and uncontrolled desktop files. Author, redline, and resolve inline quality comments within a validated 21 CFR Part 11 browser workspace.
- Simultaneous multi-author redline editing
- Automated character-level version diffing
- Zero local Word or desktop app dependencies
- Controlled print stations with dynamic microtext barcodes
Prior to batch compounding, the compounding supervisor must verify that manual paper logbook entries are signed Novaqis eLog™ Clean Hold Time status is VALID and airlock pressure interlocks (ΔP nominal) are ENGAGED.
Enterprise Validation Standards
Engineered for High-Stakes GxP Operations. Zero Compromises.
Novaqis replaces fragile point solutions with a unified, high-integrity compliance architecture. Explore live workflows, automated audit trails, and direct laboratory instrument capture below.
Paperless Master Batch Execution with Governed CPP Interlocks
Replace thousands of manual paper pages with real-time digital recipes. Review-by-Exception isolates only flagged deviations for QA release, eliminating warehouse hold backlogs.
Automated Cleanroom Hold-Time & Cascade Interlocks
Governs Clean Hold Time (CHT) and Dirty Hold Time (DHT) countdown meters, cascading pressure cascades (ΔP), and A4 continuous audit registers.
In-Browser SOP Authoring with Cryptographic Stage-Gate Governance
Author, redline, and approve controlled GxP documents entirely within your browser. Live track-changes diffs, segregation of duties, and 21 CFR §11.50 dual-witness electronic signatures prevent unauthorized desk-drawer revisions.
“Perform manual paper clearance +biometric electronic line clearance via Novaqis eLog™ prior to dispensing API.”
Volumetric Standardization Calculation Node
Dynamic formula titration worksheet computing normality N1V1 = N2V2 against potassium hydrogen phthalate with automated OOS threshold checking and un-tampered rounding rules.
Direct RS-232/TCP Fleet Capture with Zero Keyboard Transcription
Connect analytical balances, HPLCs, and Karl Fischer titrators directly to dynamic formula worksheets. Eliminate transcription fraud with automated rounding and 2-phase OOS bridges.
Cross-System Regulatory Traceability Across DMS, LMS, QMS & Batch
Continuous ALCOA+ audit verification. Links training qualification gates directly to manufacturing steps and document revisions with tamper-evident audit trails.
Automated IQ/OQ Validation Architecture
Pre-scripted, deterministic Computer Systems Validation (CSV) protocols shrink multi-month validation lifecycles to 3 weeks with automated execution dossiers.
GxP Document Summarization & SOP Verification
Runs strictly inside your validated perimeter. Prepares audit checklists, verifies operator SOP comprehension with automated checkpoints, and never trains on proprietary formulation prompts.
“What is the maximum permissible Dirty Hold Time before automated autoclaving interlock triggers?”
Biometric Identity for Self-Paced Learning, Assessments & Attendance
Regulated GxP training demands proof of genuine comprehension, not just a passive login timestamp.
Governed SOP Reading with Live Attention & Dwell Gates
Learners read effective standard operating procedures page-by-page. Embedded WebAssembly compliance gates monitor active viewing attention to enforce genuine reading dwell times (minimum 45s/page) before allowing advancement. Policy breaches are audited and escalated in real time — never silently rubber-stamped.
Prior to standard injection, equilibrate the C18 reverse-phase column at 1.0 mL/min for a minimum of 30 minutes. Verify baseline noise does not exceed 0.5 mAU. Dual analyst witnessing required for initial batch sequence.
Live verification
Governed SOP Reading with Live Attention & Dwell Gates
Page dwell · on-device gaze · audit on reject
LIMS Master Migration Studio
Paper and digital QC packs → reviewable linked masters → LIMS-ready submit
Accelerate method and worksheet digitization with rules-first extraction, optional AI assist, human review, and readiness scorecards — then hire Novaqis for any major LIMS migration and InstrumentLink automation after cutover.
DOCX and digital PDF preferred. Scans flagged.
Product → Spec → Worksheet → Tests.
Assistive extract. Humans own disposition.
Native Novaqis LIMS. Adapters via services.
• Monograph Authority: USP-NF Official Compendia
• Assay Equation: (V_smp - V_blk) × N × 8.806 / W_smp
• Instrument Profile: Agilent 1260 HPLC (Detector UV 245nm)
| Parameter | Technique | Tolerance | Parsed | Status |
|---|---|---|---|---|
| Assay (C6H8O6) | HPLC-UV (245nm) | 98.0% – 102.0% | 99.85% | Verified |
| Organic Impurity A | HPLC Isocratic | NMT 0.15% | 0.04% | Verified |
| Loss on Drying | Vacuum 105°C / 3h | NMT 0.40% | 0.18% | Verified |
| Heavy Metals (<231>) | Spectrophotometry | NMT 10 ppm | < 5 ppm | Verified |
Ingest → Extract → Review → Submit
Official Instrument SDK
Link every instrument. Feed every LIMS. Automate the lab.
Bidirectional interlinking between chromatography systems, non-chromatography instruments, and all major LIMS — governed for GxP, priced at about 10% of typical enterprise CDS / instrument-interlink cost.
Results into LIMS. Worklists back to instruments.
CDS exports, balances, KF, UV, TOC — one SDK.
Standard laboratory contracts. Native Novaqis LIMS fit.
A fraction of typical enterprise interlink licensing.
| Instrument Station | Laboratory Site | Sample / Worklist | Captured Telemetry | Channel Status |
|---|---|---|---|---|
| HPLC-Agilent-1260 | QC-Plant 1 · Chrome Line 02 | SMP-2026-0891 | Assay 99.82% (Peak Area 428,102) | Live Stream |
| Balance-Mettler-XPR | Formulation Lab · Bench 04 | WT-Batch-402 | Gross: 12.4582 g (Tare: 0.0000 g) | Captured |
| Empower-CDS-Node-04 | Analytical Dev · Stability | SEQ-AA-8102 | Injection 8 of 12 (Empower Bridge) | Syncing |
| KF-Titrator-Metrohm-905 | Raw Materials · Bench 01 | RM-Solvent-09 | Water: 0.142% w/w (1.42 mg H2O) | Verified |
Fleet control · Capture → Govern → Automate
Novaqis InstrumentLink ↔ QC LIMS Live Bus
Agilent 1260 Infinity II
Peak Area: 1,482,901
InstrumentLink SDK
Bi-directional Part 11 Ingest
Worksheet Auto-Compute
Purity: 99.85% (Passing)
SHA-256 Immutable
e3b0...a549
Multilingual
Eleven languages across the suite
The Novaqis platform (Admin, DMS, LIMS, LMS, QMS, BRM, ERP & WMS, HRMS, AuditLens, Reporting, and Nova AI) ships in English, Chinese, Kannada, Gujarati, French, Arabic, Hindi, Tamil, Telugu, Odia, and Marathi. Pick a language below to refresh labels in the preview panel. This page stays in English.
Language
The preview shows a DMS dashboard with translated navigation, metrics, table headers, sample document titles, and status labels. The marketing site copy does not change.
Priority metrics
Plant-Wide Operations · Real-time12
8,412
46
99.8%
Recent Documents
ASTM E29 Validated LedgerTracking: CPY-2026-9941
Format: Watermarked Controlled Copy
Issuance: Copy #04 of 10 (Unit 4)
UI preview · English
Why Novaqis
Built by practitioners who have shipped GxP platforms at scale
Novaqis was founded to close the gap between enterprise DMS shortlists and what teams actually experience: unstable implementations, dated UX on legacy stacks, and TCO that does not match audit-ready value. We deliver a modern regulated-operations suite you can validate, operate, and extend: Admin, DMS, LIMS, LMS, QMS, BRM, ERP, HRMS, AuditLens, Reporting, and Nova AI on one governed stack without replatforming.
Site-wide license. Model the numbers on TCO.
Hero commercial terms cover unlimited named users and plants with offline ES256 cryptographic verification. Explore our full transparent five-year TCO comparison model.
Nova AI
Intelligent layer without shadow IT
Nova AI is built for pharma and regulated operations: it runs on-premises inside your perimeter and does not train on your documents or prompts. Administrators manage a dedicated knowledge module from Admin, with audit trail and electronic signatures on changes. In DMS, it helps reviewers summarize lengthy SOPs and work instructions and flags spelling and grammar mistakes so approval queues move faster without bypassing human sign-off. In LMS, learners get section summaries and AI comprehension questions as they read governed PDF and HTML content. Platform guidance and permission-scoped operational summaries span the suite on the same security model. Nova AI is non-critical, human-in-the-loop assistance only.
Document & platform
Copilot and document assistance
Conversational assistance
Streaming guidance grounded in Novaqis help content and menu context in Admin, DMS, LMS, and QMS, scoped to the signed-in user and site.
Document summarisation for reviewers
Condense long SOPs, policies, and work instructions inside DMS so reviewers and approvers grasp scope faster, subject to the same document permissions as the editor.
Spelling & grammar proofreading
Surface spelling mistakes and grammar issues across large controlled documents during review, helping reviewers focus on technical accuracy, not typos.
Operational summaries
Read-only counts and summaries for users, roles, functional groups, and document status, filtered by Admin permissions.
Learner summaries & checkpoints
In LMS, Nova AI condenses assigned reading for learners and generates multiple-choice comprehension questions after page milestones, from a reusable pool with random combinations per learner, plus configurable remediation when answers are wrong.
Administrator-controlled knowledge
Knowledge guides and catalog entries are managed in Admin with entity audit trails and electronic signatures, so help content and AI rules stay aligned with your validated configuration.
Permission-gated capabilities
Chat, document assist, and data queries are assigned through the same role model as other Novaqis features — not a bypass around segregation of duties.
On-premises deployment
Nova AI runs as a service within your deployment boundary; models and data can remain inside your perimeter.
Reporting & capture
Data intelligence and OCR
Capability routing
Config-driven routing so chat, document assist, reporting, and OCR can use appropriate models for each task.
Natural language reporting
Plain-language questions translated into read-only queries against Reporting event data — without granting SQL access broadly.
Compliance and operational reports
Reports generated from the same audit-friendly event history Reporting collects, with row limits and logging.
OCR for scans and PDFs
Structured text extraction for search, bulk onboarding, and review queues within repositories you control.
Background jobs with progress
Long-running report and OCR workloads with job tracking and real-time progress in the UI.
Scalable inference
Deployment options from CPU-only environments through multi-GPU production configurations.
Executive compliance views
Trend analysis, alerts, and audit-readiness indicators for quality leadership — subject to your SOPs and review.
Suite evaluation
Compare Novaqis in a serious GxP shortlist
Independent regulated-operations platform: how we approach side-by-side evaluations, RFP dimensions, and what to test in a POC. Full article with structured FAQ on the dedicated page.
Open full comparison guideEnterprise FAQ
Frequently asked questions
Direct regulatory and architectural answers for 21 CFR Part 11, multi-plant licensing, and air-gapped deployment. More detail lives on the full technical FAQ.
What is Novaqis?+
Novaqis is a unified GxP software suite for pharmaceutical and biotech operations from Novaqis Technologies LLP. Buyers evaluate it for pharma LIMS, 21 CFR Part 11 document management (DMS), GxP QMS, electronic batch records (BRM), InstrumentLink (Instrument SDK), Lab Digitize (method digitization), LMS, eLog, ERP, and HRMS on one governed stack—on-premises or private cloud.
Which compliance standards does Novaqis support?+
Novaqis is designed to support US FDA 21 CFR Part 11, EU Annex 11, WHO GMP, PIC/S, GAMP 5, and CDSCO Revised Schedule M with immutable ALCOA+ audit trails, cryptographic electronic signatures, and turnkey validation execution packs. Customers still complete validation in their own environment.
What is Novaqis Lab Digitize?+
Novaqis Lab Digitize turns DOCX and digital PDF QC packs into linked LIMS masters (Product → Specification → Worksheet → Tests) with AI-assisted extraction, human review, and readiness scorecards. It supports Novaqis LIMS natively and other major platforms via professional services adapters — sold as scoped demo plus migration assessment.
What is Novaqis InstrumentLink?+
Novaqis InstrumentLink is the official Instrument SDK for bidirectional LIMS ↔ instrument interlinking across chromatography and non-chromatography systems and all major LIMS — at about 10% of typical enterprise CDS / instrument-interlink licensing cost. It complements Novaqis LIMS IDAS for in-product capture.
Can Novaqis InstrumentLink replace expensive brand SDKs like Waters Empower Toolkit or Thermo Chromeleon SDK?+
Yes. Novaqis InstrumentLink is an open, vendor-neutral Instrument SDK designed to replace expensive proprietary brand toolkits ($20,000–$40,000+ per instrument fleet). It normalizes Waters Empower, Thermo Chromeleon, Agilent OpenLab, Shimadzu, and analytical bench balances under one validated GAMP 5 Category 4 control plane, posting bidirectionally into Novaqis LIMS or any major commercial LIMS (LabWare, SampleManager, SAP QM) at approximately 10% of legacy interface licensing costs.
What is Novaqis eLog and how does it replace paper logbook binders?+
Novaqis eLog is an autonomous cleanroom and equipment digital logbook. It enforces a deterministic 6-state finite state machine, EU GMP Annex 1 containment cascading, hold-time countdown timers, return-to-dirty maintenance guardrails, and Landscape A4 Part 11 chronological audit registers.
How does Novaqis LIMS differ from a spreadsheet-centric QC lab?+
Novaqis LIMS ships 22 native QC laboratory modules with dynamic formula worksheets, volumetric standardization (N1V1 = N2V2), working-standards lot tracking, 2-phase OOS/OOT investigations, ICH stability protocols, Grade A–D environmental monitoring, IDAS instrument acquisition (extend fleet-wide with InstrumentLink), and SAP QM usage-decision posting.
How does Novaqis DMS author documents without desktop Word?+
Novaqis DMS provides in-browser rich authoring with track changes, inline comments, side-by-side version diffs, and copy-numbered pantograph print security so authors do not depend on a desktop word processor for the controlled record.
Can Novaqis be deployed on-premises in air-gapped facilities?+
Yes. Novaqis supports on-premises air-gapped deployment with offline ES256 cryptographic licensing, as well as dedicated sovereign private cloud on AWS, Azure, or GCP virtual private clouds.
Customer success
Support built for regulated operations
Licensed customers get a full ticket desk: structured cases, SLA visibility, audit-friendly e-sign steps, and closure confirmation. Details and portal login on the support page.
A unified platform, not disconnected single-point tools.
One governed stack sharing native identity, append-only ALCOA+ audit trails, offline ES256 licensing, and GAMP 5 Category 4 validation.
Novaqis Admin
Organizations, sites, users, roles, SSO, licensing, audit, and DMS migration, the backbone for segregation of duties across every module.
1,280
100% SAML 2.0 SSO48 Roles
SoD Conflicts: 0ES256
Offline HSM Sealed15 min
Auto Inactivity IdleReady to map the full platform?
The full platform: Admin, DMS, LIMS, LMS, QMS, BRM, ERP, HRMS, AuditLens, Reporting, and Nova AI. Explore every module on one governed stack.
Start your free trial or speak with our team about flexible hosting options.
Talk directly with the team that builds Novaqis
Whether you are planning a formal RFP for 22-module LIMS, evaluating 21 CFR Part 11 DMS authoring, or verifying air-gapped on-prem deployment — you speak with practitioners who operate regulated software.
<24h
First reply
NDA-ready
Security reviews
Live stack
Not slides-only
Direct Contact
Email is ideal for attachments, security questionnaires, and formal procurement packets.
Project enquiry
Start a conversation
Share company, sites, deployment preference (on-premise vs private cloud), and what modules you want to validate first.