Question 1

What is Novaqis?

Accepted Answer

Novaqis (Novaqis Technologies LLP, Vadodara) develops a modular suite for regulated operations. Admin covers identity, organizations, licensing, SSO, and server monitoring; DMS delivers GxP document management with workflows, change control, controlled print, training gates, and audit trails; LIMS provides 22-module paperless QC informatics; Lab Digitize digitizes QC packs into linked LIMS masters for migration; InstrumentLink is the official Instrument SDK for bidirectional LIMS ↔ instrument / CDS interlinking; LMS and QMS provide training competency and quality events on the same platform; BRM delivers electronic batch and production records with DMS and LMS interlocks; eLog covers cleanroom and equipment digital logbooks; ERP and HRMS cover supply chain and workforce; AuditLens provides cross-system audit and inspection intelligence; Reporting provides session and lifecycle insight without shadow exports; and Nova AI is our pharma-ready, on-premises assistant with a dedicated knowledge module administrators control. Founded by Ashutosh Biswal in 2025.

Novaqis addresses unstable legacy implementations, dated UX, and high TCO with a production-grade alternative teams can validate and operate with confidence.

Question 2

What is Nova AI and what can it do?

Accepted Answer

Nova AI is Novaqis’s in-house assistant built for pharma and regulated operations. It runs on-premises (or in your cloud) inside your perimeter. It is not a consumer generative-AI service that trains on your documents or prompts, your content stays under your governance. Administrators manage what the assistant may use through a dedicated knowledge module: curate and update the knowledge base, control guidance content, and keep changes auditable with electronic signatures where policy requires. Capabilities include conversational guidance, document assist, LMS comprehension checkpoints, operational summaries, OCR, and natural-language reporting, always permission-scoped across Admin, DMS, LIMS, LMS, QMS, BRM, ERP, HRMS, and AuditLens.

Question 3

How does Novaqis handle controlled printing?

Accepted Answer

Novaqis DMS provides end-to-end controlled print: request → approve → token → print → register, with incharge-scoped queues, watermark policies, pantograph anti-copy rendering, crypto QR verification, optional geo-fencing, and training gates that block print when qualification is required. Generic browser Print is not an unlogged escape hatch.

Question 4

Is Novaqis a good DMS for pharmaceutical companies?

Accepted Answer

Novaqis DMS is built for pharmaceutical and biotech quality use cases: controlled documents, workflows, signatures, change control, controlled print, and auditability, with design themes aligned to 21 CFR Part 11 and EU Annex 11. Suitability depends on your validation strategy, we recommend guided evaluation and IQ/OQ/PQ in your environment.

Question 5

Does Novaqis support 21 CFR Part 11-style electronic records?

Accepted Answer

Novaqis DMS is engineered with Part 11–relevant capabilities (electronic records, signatures, traceability). Compliance is a shared responsibility: your organization validates the system in context. We do not claim automatic regulatory approval.

Question 6

Can we deploy on our own infrastructure?

Accepted Answer

Yes. Novaqis runs inside your perimeter, on-premises or in your cloud, so data residency stays under your governance. This is a common requirement for Indian pharmaceutical plants and other regulated manufacturers with residency or sovereignty policies.

Question 7

Is Novaqis suitable for pharmaceutical companies in India?

Accepted Answer

Yes. We are based in Vadodara and build for plants that serve India and export markets, run on your infrastructure, work in languages your teams use, and grow users and sites without a surprise seat bill. Your quality system and validated state decide compliance; we help you operate documents, training, quality, batch records, and inspection readiness on one platform. See Solutions → India pharma.

Question 8

Do you charge per user or per site (plant)?

Accepted Answer

No. Novaqis does not charge extra for user licenses or plant (site) licenses. Users and sites are included without a seat or plant cap in our standard model, so growth in headcount or manufacturing footprint does not automatically multiply license cost the way many enterprise suites do. Confirm scope for your deployment during presales.

Question 9

How does Novaqis compare on platform license cost and AMC?

Accepted Answer

Novaqis platform license and annual maintenance (AMC) are positioned at roughly half of comparable enterprise pharma DMS and quality suite quotes, among the strongest commercial models in the category. A complete documents + training + quality suite often costs less than many plants pay for document control alone. Exact figures depend on modules, instance count (Production vs Training), and services. Many teams also reduce Microsoft Word seat spend because controlled authoring runs in our built-in editor. We do not publish list prices, contact us for a tailored quote. See Value & TCO.

Question 10

Is Novaqis validated out of the box?

Accepted Answer

Software is GxP-oriented; your organization performs IQ/OQ/PQ in your environment. We discuss documentation and deployment models during presales.

Question 11

What do Novaqis LMS and QMS cover?

Accepted Answer

Novaqis LMS covers curricula, governed PDF/HTML reading with camera-assisted attention and identity monitoring, virtual training rooms for ILT/OJT, AI comprehension checkpoints, assessments with lock-on-fail, document-linked retraining, and competency evidence on the same identity and audit fabric as Admin and DMS. Novaqis QMS covers Configuration Studio for governed forms and workflows, AI-assisted workflow design and question generation, plus deviation, CAPA, change control, audit, complaint, OOS/OOT, and management review, with suite-native traceability to DMS and LMS.

Question 12

What does Novaqis LIMS cover for pharmaceutical QC laboratories?

Accepted Answer

Novaqis LIMS delivers 22 native QC laboratory modules out of the box with zero per-user seat license penalties. Key capabilities include dynamic mathematical formula testing worksheets (Assay, Related Substances, LOD, KF Water, USP <711> dissolution profiles), automated volumetric solution standardization (N1V1 = N2V2), working reference standards lot tracking, 2-phase OOS/OOT investigations with 5-Why and Ishikawa root-cause trees, ICH Q1A stability chamber pull management, cleanroom Grade A–D environmental monitoring, IDAS instrument acquisition (extend fleet-wide with Novaqis InstrumentLink, the official Instrument SDK), and bidirectional SAP QM integration.

Question 13

What is Novaqis InstrumentLink and how does it differ from LIMS IDAS?

Accepted Answer

Novaqis InstrumentLink is the official Instrument SDK for bidirectional LIMS ↔ instrument interlinking across chromatography and non-chromatography systems and all major LIMS, priced at about 10% of typical enterprise CDS / instrument-interlink licensing. IDAS remains the in-product capture module inside Novaqis LIMS; InstrumentLink is the multi-site fleet SDK. Use them together for end-to-end lab automation.

Question 14

What is Novaqis Lab Digitize and how does it support LIMS migration?

Accepted Answer

Novaqis Lab Digitize turns DOCX and digital PDF QC packs into linked LIMS masters (Product → Specification → Worksheet → Tests) with rules-first extraction, optional AI assist, human review, and a readiness scorecard. It accelerates master and worksheet digitization for Novaqis LIMS or any major laboratory platform via professional services adapters. Commercial path: scoped demo and migration assessment — not overnight auto-migrate. Pair with InstrumentLink after cutover for fleet automation.

Question 15

How does Novaqis BRM handle electronic batch manufacturing records (eBMR/MES)?

Accepted Answer

Novaqis BRM eliminates paper batch binders by unifying step-level master formula digital execution on plant floor tablets with real-time Critical Process Parameter (CPP) interlocks, electronic line clearance checklists, operator qualification gates from Novaqis LMS, and digital equipment logbooks. It connects natively with Novaqis ERP to query released lots, account for material consumption during dispensing, and automatically generate finished goods receipts and work order completions upon dual e-signed QA release. Its automated Review-by-Exception dashboard reduces final QA batch disposition from 3 days to under 2 hours.

Question 16

What capabilities does Novaqis ERP provide for manufacturing supply chain and asset maintenance?

Accepted Answer

Novaqis ERP is a modern Enterprise Resource Planning system engineered for regulated manufacturing. Core capabilities include: multi-plant Inventory & Warehouse Management (WMS) with bin-level stock balances and FEFO/FIFO lot tracking; Production Planning & Work Orders with multi-level Bills of Materials (BOM) and stage-wise routing; Enterprise Asset Management with automated preventive maintenance (PM) schedules, recurring job card assignments, calibration intervals with certificate management, breakdown work orders, and MTBF/MTTR reliability analytics; Strategic Procurement with 3-way invoice matching; and General Ledger Financial Accounting with automated labor cost center posting from Novaqis HRMS.

Question 17

How does Novaqis HRMS handle global payroll, statutory taxation, and biometric shift governance?

Accepted Answer

Novaqis HRMS delivers complete human resource and payroll governance for manufacturing plants: automated multi-currency payroll computing multi-tier salary components, allowances, and direct bank disbursement files; statutory tax compliance calculating Income Tax slabs, automated TDS deductions, Form 16 generation, Provident Fund (PF), ESI, Professional Tax, and Gratuity provisioning; 24/7 multi-shift rotational rosters with night shift allowances and shift handover tracking; direct hardware biometric integration with fingerprint and facial recognition readers; automated overtime (OT) and sandwich leave enforcement; and native labor cost center integration with Novaqis ERP.

Question 18

Which biometric machines and access control systems does Novaqis HRMS support out of the box?

Accepted Answer

Novaqis HRMS provides direct, native plug-and-play compatibility with all leading industrial biometric device manufacturers, including eSSL, Matrix COSEC, ZKTeco, Suprema, Realtime, Hikvision, and HID Global. The system supports multi-modal biometric authentication: optical & capacitive fingerprint readers, AI-powered 3D facial recognition cameras, palm vein scanners, and contactless RFID smart card turnstiles. Punch data is ingested in real time via direct TCP/IP push listeners, native SDK background services, and authenticated REST webhook APIs, eliminating manual USB thumb drive data extraction and CSV spreadsheet uploads.

Question 19

What is Novaqis AuditLens and how does Inspection Room Mode work?

Accepted Answer

Novaqis AuditLens is an inspection intelligence engine that unifies audit trails across DMS, LIMS, LMS, QMS, and BRM into a single interactive view. During regulatory audits (US FDA, WHO GMP, UK MHRA, CDSCO), Inspection Room Mode projects clean, tamper-proof record histories with instant 1-click export of cryptographically signed PDF evidence dossiers, eliminating late-night binder compilation and manual photocopying. It continuously validates ALCOA+ data integrity to prevent 483 audit observations.

Question 20

Does Novaqis support dedicated validated cloud hosting as well as on-premises air-gapped deployment?

Accepted Answer

Yes. Novaqis offers three validated deployment architectures: (1) Dedicated Validated Private Cloud on AWS, Azure, or GCP with single-tenant VPC isolation, automated encrypted backups, SOC 2 / ISO 27001 security, and 99.99% uptime SLA; (2) 100% Sovereign Air-Gapped On-Premises on bare-metal plant servers with offline ES256 asymmetric cryptographic licensing and zero outbound telemetry; and (3) Hybrid Edge-Cloud Architecture where plant edge servers run BRM and LIMS with sub-millisecond latency while syncing asynchronously with the corporate quality cloud.

Question 21

How does Novaqis support CDSCO Revised Schedule M compliance for Indian pharma?

Accepted Answer

Novaqis delivers turnkey compliance with CDSCO Revised Schedule M (2024–2026) standards: automated, immutable ALCOA+ electronic audit trails, role-based segregation of duties, pre-configured GAMP 5 Category 4 Computer System Validation (CSV / CSA) documentation (IQ/OQ/PQ), copy-numbered pantograph print control, computerized environmental monitoring, and sovereign on-premises data residency inside India.

Question 22

How does Novaqis enforce US FDA 21 CFR Part 11 and EU Annex 11 compliance?

Accepted Answer

Novaqis enforces 21 CFR Part 11 and EU Annex 11 natively across all 6 core modules: cryptographic electronic signatures with explicit meaning-of-signature manifestations (Author, Reviewer, Approver, QA Release), immutable computer-generated audit trails synchronized via NTP time servers, strict role-based access control (RBAC), session timeout security, and long-term archiving in PDF/A standard formats.

Question 23

How does Novaqis implement the ISPE Pharma 4.0™ Operating Model?

Accepted Answer

Novaqis implements the ISPE Pharma 4.0™ holistic operating model across its four core dimensions: Resources (cleanroom-grade tablets, barcode scanners, and edge hardware), Information Systems (ISA-95 Layer 0–5 convergence connecting SCADA/DCS, LIMS, BRM, and ERP), Culture (ALCOA++ data integrity enforced by real-time validation gates rather than retrospective policing), and Organization & Processes (Review-by-Exception, automated line clearance, and continuous process verification). Instead of operating isolated departmental silos, Novaqis provides a single, unified database architecture with instant cross-module interlocks, eliminating latency and audit vulnerabilities between manufacturing, quality control, and executive management.

Question 24

What is Review-by-Exception (RBE) batch release and how does Novaqis accelerate lot disposition?

Accepted Answer

Review-by-Exception (RBE) is a modern regulatory-endorsed paradigm where QA teams review *only* deviations, Critical Process Parameter (CPP) excursions, Critical Quality Attribute (CQA) out-of-trend events, and operator overrides rather than manually flipping through 300+ pages of conforming data. Novaqis BRM and LIMS continuously evaluate production step data against Master Batch Record tolerances and ASTM E29 rounding rules. Conforming steps are auto-verified with cryptographic audit trails, while exceptions are immediately flagged into an interactive QA disposition cockpit with linked deviations, OOS records, and root-cause analyses. Plants using Novaqis typically cut batch disposition cycles from 3–5 business days down to under 2 hours, freeing millions in working capital.

Question 25

How does Novaqis support FDA Computer Software Assurance (CSA) and GAMP 5 Category 4 validation?

Accepted Answer

Novaqis provides pre-packaged GAMP 5 Category 4 (Configured Product) validation accelerator kits that fully align with the US FDA’s Computer Software Assurance (CSA) risk-based framework. Rather than forcing clients into months of redundant, low-value documentation testing out-of-the-box vendor code, our CSA documentation focuses testing effort on high-risk patient safety and product quality touchpoints. Customers receive turnkey, auditable templates including: User Requirements Specifications (URS), Traceability Matrices (RTM), Vendor Audit Summaries, Installation Qualification (IQ), Operational Qualification (OQ) test scripts with pre-executed positive/negative test outcomes, and Performance Qualification (PQ) protocols. This fast-tracks typical system go-lives from 9–12 months down to 4–8 weeks.

Question 26

Can Novaqis connect directly to plant floor DCS/SCADA and analytical instruments without custom middleware?

Accepted Answer

Yes. Novaqis features native Industrial Data Acquisition & Supervisory (IDAS) connectors for plant-floor automation without expensive third-party middleware licenses. The platform supports OPC UA, Modbus TCP/IP, and MQTT Sparkplug B to stream temperature, agitation, pressure, and weight telemetry from PLC/DCS systems into electronic batch records. In the laboratory, Novaqis LIMS IDAS and Novaqis InstrumentLink (the official Instrument SDK) connect bidirectionally to analytical instruments — HPLC/GC chromatography data system exports, UV-Vis spectrophotometers, balances, and other bench systems — via serial, network, and secure file drops, automatically parsing results into validated test worksheets and returning worklists to instruments across all major LIMS.

Question 27

Why does Novaqis reject per-user seat licensing in favor of a transparent plant-tier model?

Accepted Answer

Legacy life sciences vendors (Veeva, TrackWise, MasterControl, Werum) charge steep annual per-user 'seat taxes' ($1,200–$3,500/seat/year), which penalizes pharmaceutical plants for doing the right thing: giving every cleanroom operator, warehouse technician, and line supervisor their own individual digital credentials. This punitive pricing often forces plants to share generic logins, directly causing catastrophic FDA 483 and Warning Letter observations under 21 CFR 211.68 / 21 CFR Part 11. Novaqis charges zero seat taxes—our transparent tier is based on the plant footprint with unlimited users, unlimited document revisions, and unlimited concurrent connections. This ensures 100% of your workforce has sovereign, auditable digital identity without inflating your software bill.

Question 28

Can Novaqis be used in non-pharma industries like Food, Cosmetics, and Specialty Chemicals, and can e-signatures be simplified for faster UX?

Accepted Answer

Yes. While Novaqis was engineered to meet the world’s strictest pharmaceutical standards (US FDA 21 CFR Part 11, EU Annex 11, GAMP 5 Category 4), its modular architecture features Adaptive Compliance Governance. This allows quality leadership to configure electronic signature friction dynamically by plant, department, or workflow:

- Strict Regulated Mode (Pharma & Biotech): Enforces full 21 CFR Part 11 cryptographic ceremonies—mandatory password/biometric re-authentication, explicit statutory meaning selection, dual-witness witnessing, and SHA-256 tamper-evident digital envelopes.
- Lean Agile Mode (Food, Cosmetics, Nutraceuticals & Specialty Chemicals): In industries governed by FDA MoCRA 2022, FSMA 204, ISO 22716, or ISO 9001, repetitive re-authentication prompts create operator fatigue and throttle line throughput. In Lean Mode, operators complete sign-offs with instantaneous 1-click execution bound to their verified active session. Full ALCOA+ audit trails (timestamp, authenticated user ID, terminal IP, device fingerprint, and before/after states) remain 100% active and unalterable behind the scenes.

This makes Novaqis the ideal unified operations platform for diversified manufacturers running pharmaceutical, nutraceutical, cosmetic, and food production plants from a single pane of glass.

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