21 CFR Part 11
Electronic records & signatures
GxP · 21 CFR Part 11 · EU Annex 11
Regulated operations software for pharma, biotech & GMP
GxP documents, intelligent training, quality processes, electronic batch records, AuditLens inspection intelligence, and Nova AI—one regulated-operations platform for pharma, biotech, and GMP teams. Explore the full suite →
Novaqis is a regulated-operations platform—not a narrow point product. Platform modules: Admin, DMS, LMS, QMS, BRM, AuditLens, Reporting, and Nova AI—documents, training, quality events, batch records, audit intelligence, reporting, and Nova AI on one governed stack. AuditLens traces entities across licensed modules; server monitoring in Admin keeps infrastructure health beside identity and licensing. Manufacturing steps can require LMS qualification before execution. Fully on-premise capable. A disciplined POC shows a clear generational advantage—see for yourself.
Prefer a structured evaluation? See suite evaluation, Value & TCO, or anonymized case studies.
Intelligence / Dashboard
Pre-inspection readiness
Scope: AUDITLENS · DMS · LMS · QMS · BRM
Pre-inspection readiness
Executive status
ACTION REQUIRED
Open audits
4
2 FDA · 1 Internal
Open findings
12
3 critical
Anomalies
7
Cross-module
Trace coverage
94%
Licensed modules
Entity trace — SOP-QA-0142
Live leaf calls[DMS]
SOP-QA-0142 v3.0 Effective
Published · training gate on
[LMS]
12 / 14 qualified readers
2 overdue retrainings
[QMS]
CAPA-2026-0088 linked
Root cause closed
[BRM]
Referenced in BCH-2026-0142
Issuance token verified
Anomaly findings
CRITICAL
Effective SOP without training
[LMS] Close overdue assignments
MAJOR
CAPA closed without doc revision
[DMS] Open change control
MINOR
Operator qual gap on Line 03
[BRM] Hold step until LMS gate
Cross-system audit intelligence—entity trace, anomaly scan, and readiness status scoped to licensed DMS, LMS, QMS, and BRM modules. Executive status you can defend in inspection.
Switch tabs — Admin, DMS, LMS, QMS, BRM, AuditLens, monitoring, editor, Nova AI, and more.
Nova AI · AuditLens
Embedded across Admin, DMS, LMS, QMS, BRM, 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.
AuditLens · cross-system readinessServer monitoring in AdminFacial mesh · self-paced & assessmentsVirtual training rooms & ILTControlled print & document securityEBR · e-logbooks · LMS qualification gatesOn-premise capable · Part 11 themes
Roadmap: LIMS—and more as the portfolio expands. Built by teams who have operated large-scale GxP quality and document platforms for years.
Our biggest commercial advantage
Unlimited users & plants. License & AMC ~50% lower.
Novaqis is priced for regulated teams that need to scale—not for vendors that multiply fees with every seat, site, and desktop author. A full documents + training + quality suite often costs less than many plants pay for document control alone.
Many enterprise pharma DMS and quality suites add per-user licenses, per-plant surcharges, high annual maintenance bands, and separate Microsoft Word seats for authors. Novaqis bundles growth into the platform model below.
Unlimited users — no seat fees
We do not charge per-user license fees. Add quality, manufacturing, operations, and training users without seat-count surcharges that inflate every budget cycle.
Unlimited sites (plants) — no plant fees
Manufacturing and distribution sites are included without incremental plant-license charges—the extra line items many enterprise suites stack on top of platform fees.
Suite value, not document-only spend
A complete documents + training + quality suite often costs less than many plants pay for document control alone—so you grow capability without stacking three vendor contracts.
Platform license ~50% lower
Novaqis platform licensing is positioned at roughly half of comparable enterprise pharma DMS and quality suite quotes teams bring to evaluation—among the strongest commercial models in regulated pharma software.
AMC ~50% lower
Annual maintenance is structured to stay among the lowest in the category—typically about 50% below comparable enterprise maintenance bands.
Save Microsoft Word license spend
Author, review, and approve inside Novaqis with track changes, comments, and workflows—our built-in editor replaces day-to-day Word dependency and the per-seat desktop license sprawl that follows.
Indicative commercial positioning; modules, instances (Production vs Training), and services affect final pricing. Contact us for a tailored quote. We do not publish list prices on this site.
1M+Document library capacity
21 CFRPart 11 ready
500Concurrent users (typical)
GxPGxP-ready themes
Compliance
Designed for regulated environments
EU Annex 11
Computerised systems
ALCOA+
Data integrity mindset
Private deploy
Your infra, your control
Intelligent training
Biometric identity for self-paced learning, assessments & attendance
Regulated training needs more than a login timestamp. Novaqis LMS uses on-device face attention, landmark verification, and server-enforced heartbeats during governed reading and assessments—plus fingerprint and passkey enrollment in Admin for ILT and OJT attendance marking, configurable to your SOP and validation scope.
3. Sampling and testing
Collect samples per the approved plan before batch release. Notify QA within one working day.
Min dwell 45s
Live verification
MatchVerified
Quality98%
LiveOK
Governed SOP reading with live attention
Page dwell · on-device · audit on reject
Flagship capabilities
Built for audits. Designed to win evaluations.
Facial mesh tracking for self-paced reading and assessments. Virtual training rooms in LMS. Pantograph print security in DMS. Configuration Studio in QMS. Electronic batch records, LMS qualification gates, and e-logbooks in BRM. One platform—not a patchwork of point tools.
Facial mesh tracking, page dwell validation, and identity continuity during governed SOP reading
←SOP-QA-0142 · Read & understand
Attention activePage 3/12
3. Sampling and testing
Collect samples per the approved plan before batch release. Document any deviation from the sampling schedule in the batch record and notify QA within one working day.
3.1 Retain samples
Retention quantities must match the effective specification attached to the product master.
Min dwell 45s
LMS
Training that proves presence
Know the learner stayed with the SOP—not just opened it
Self-paced reading with attention checks built for regulated work: progress only counts when your policy says the person was truly engaged. Classroom attendance can use identity you trust—not a paper roster on the wall.
- Meaningful reading checks, not a login timestamp
- Clear evidence when progress is rejected
- Attendance that stands up in audit conversations
LMS
Virtual training rooms
Live sessions that stay inside your quality story
Run instructor-led and on-the-job sessions with schedules, trainer control, and attendance that rolls into the same competency picture as document training—without chasing recordings in a separate app.
- Trainer-led sessions with governed attendance
- Completion evidence beside curricula
DMS
Document security & controlled print
Copies you can explain when someone asks where they went
Controlled issuance with the protections plants expect—watermarks, secure print, copy tracking, recall—and training awareness before someone views or prints a critical document.
- Live view of what was issued
- Training-aware access before print
DMS
Full document lifecycle
Author, approve, and retire without shadow file shares
Write and review in the browser, route approvals, manage change, and keep a trail that quality and inspectors can follow. Nova AI can help reviewers summarize and catch language issues—humans still decide.
- Built for large document libraries
- Migration paths from older systems
QMS
Quality your way
Shape forms and workflows to your SOPs—not the other way around
Configure deviation, CAPA, change, audit, and related programs so they feel like your site. Changes stay governed, signed, and auditable—so you are not waiting months for a vendor release to match reality.
- Processes that mirror how QA already works
- One place for tasks across quality work
- Configuration you can defend
QMS
Quality that reaches the floor
When quality says hold, manufacturing feels it
Quality events are not a parallel tracker. Holds, document impact, and training follow-through can connect to how batches move—so the plant and QA share one operational truth.
- Holds that matter at release
- Documents and training stay in the loop
- Fewer surprises the week before inspection
QMS
Faster quality design
Draft smarter. Approve like you always do.
Nova AI helps quality teams sketch workflows and assessment questions faster—then your reviewers approve and sign before anything goes live.
- Assist for design work
- People stay in control
BRM
Electronic batch records
Execute batches with the right papers and the right people
Recipes, execution, clearance, and release on one clear record—connected to controlled documents and operator readiness so the floor is not guessing from binders and chat messages.
- Right document context before you start
- Operator readiness visible at the step
- Quality holds respected at release
BRM
Floor records without binders
Materials and logbooks beside the batch story
Keep material context and electronic logbooks with the batch—signed and corrected the way regulated work expects—so QA is not hunting paper after the run.
- Material context with the batch
- Logbooks that match the batch story
AuditLens
Inspection readiness
Rehearse calmly. Walk in prepared.
Plan the year, practice with mock audits, and see how your licensed systems connect—so leadership knows where you stand before someone arrives at the gate.
- Plan and rehearse before the real visit
- Only the modules you license
- Findings that can become follow-up work
Platform
Made for Indian pharma
Local understanding. Global expectations.
Built in Vadodara for plants that serve India and export markets—run on your servers or private cloud, work in languages your teams use, and grow plants and users without a surprise seat bill.
- Your data, your infrastructure
- Strong value vs. typical enterprise suites
- One platform story as you grow
Admin
Server monitoring
See system health next to identity and licensing
Know when nodes are under pressure—CPU, memory, disk, services—without a separate ops console that never talks to your validated stack.
- Live health by node
- Alerts when things tighten
- History you can keep
Nova AI
Nova AI across the suite
Helpful—without ignoring who you are
Summaries for reviewers, reading help for learners, plain-language answers for operators—always limited by the same access rules as the rest of Novaqis, and able to run inside your walls.
- Respects roles and permissions
- No need to send work to a public cloud
Platform
One platform
Documents, training, quality, batches, audits—one login story
Shared people, sites, and licensing across the suite. Add modules as you are ready—without stitching five vendors into one inspection narrative.
- Unlimited users and plants in our standard model
- On-premise capable end to end
Multilingual
Eleven languages across the suite
Novaqis Admin, DMS, LMS, QMS, Reporting, and Nova AI ship 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.
Dashboard
Site APriority metrics
My approvals & reviews
12
Effective
8,412
Pending approval
46
Recent Documents
Document #Document TitleStage
SOP-QA-0142Batch record reviewPublished
WI-MFG-0088Line clearance checklistUnder document approval
POL-HR-0031GMP training policyUnder preparation
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, LMS, QMS, BRM, AuditLens, Reporting, and Nova AI on one governed stack, with LIMS on the roadmap without replatforming.
Total cost of ownership
Unlimited users and plants. License and AMC about half.
Enterprise GxP suites often multiply cost with every user, site, and Word seat. Novaqis is priced for scale: no per-user or per-plant license fees, platform and maintenance positioned at roughly 50% below comparable enterprise quotes—and a complete documents + training + quality suite that often costs less than many plants pay for document control alone.
Unlimited users — no seat fees
We do not charge per-user license fees. Add quality, manufacturing, operations, and training users without seat-count surcharges that inflate every budget cycle.
Unlimited sites (plants) — no plant fees
Manufacturing and distribution sites are included without incremental plant-license charges—the extra line items many enterprise suites stack on top of platform fees.
Suite value, not document-only spend
A complete documents + training + quality suite often costs less than many plants pay for document control alone—so you grow capability without stacking three vendor contracts.
Platform license ~50% lower
Novaqis platform licensing is positioned at roughly half of comparable enterprise pharma DMS and quality suite quotes teams bring to evaluation—among the strongest commercial models in regulated pharma software.
AMC ~50% lower
Annual maintenance is structured to stay among the lowest in the category—typically about 50% below comparable enterprise maintenance bands.
Save Microsoft Word license spend
Author, review, and approve inside Novaqis with track changes, comments, and workflows—our built-in editor replaces day-to-day Word dependency and the per-seat desktop license sprawl that follows.
Indicative commercial positioning; modules, instances (Production vs Training), and services affect final pricing. Contact us for a tailored quote. We do not publish list prices on this site.
Capabilities
Depth across the regulated stack
Architecture
One platform philosophy
Admin is the control plane; DMS, LMS, QMS, BRM, AuditLens, and Reporting are operational modules; Nova AI accelerates work under the same identity and audit fabric. BRM manufacturing steps can verify LMS qualification before an operator executes—and electronic logbooks stay on the same stack as the batch record.
Solutions
Many regulated workflows. One platform philosophy.
From documents, training, quality events, and electronic batch records to LIMS on the roadmap—Novaqis is a unified regulated-operations platform. Add modules without ripping out identity, audit, or deployment every time.
Laboratory (roadmap)
LIMS-class workflows on the same platform story.
Laboratory informatics that shares identity, documents, and audit vocabulary with the rest of the suite—so lab data and quality records do not live in disconnected silos.
Samples & workflowsInstrument themesGxP alignmentDesign partners
Platform
Built different. Designed for scale.
The same architecture underpins every solution in the suite—from document control and reporting to AI and future lab or manufacturing modules—so performance, security, and validation patterns stay consistent as you expand.
Built-in document editor
Author, review, and approve controlled documents inside Novaqis — with track changes, comments, electronic signatures, and version control. No Microsoft Word dependency for daily work—and no per-seat Word license sprawl for authoring teams.
Modern platform architecture
Built on .NET 10 with real-time updates, Redis caching, and integrated Nova AI — so document work, reporting, and assistance stay inside the environment you validate.
Built for scale
Many legacy DMS products degrade around 10,000–15,000 active documents. Novaqis uses paged APIs, indexed search, and load-balancer-ready services so larger libraries remain workable without replatforming.
Security & governance first
Offline ES256 licensing, encrypted data, role-based access, ALCOA+ audit trails, and electronic signatures aligned with 21 CFR Part 11 and EU Annex 11.
Efficient deployment
Disciplined resource use on customer-managed infrastructure, with a clear path to add capacity as document volume and concurrent use increase.
Nova AI for reviewers & learners
In DMS, summarize long controlled documents and surface spelling and grammar issues during review. In LMS, learners get section summaries and AI comprehension checkpoints as they read governed PDF and HTML content—permission-gated, human-in-the-loop assist, not a shadow chat tool.
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.
Explore Nova AIDocument & 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 guideHelp
Frequently asked questions
Part 11, Annex 11, licensing, modules, and deployment—quick answers on the full FAQ page, or jump to contact for a tailored walkthrough.
Browse all FAQ answersCustomer 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.
Product portfolio
A regulated-ops suite — not a single point solution.
Novaqis is a regulated-operations platform: Admin, DMS, LMS, QMS, BRM, AuditLens, Reporting, and Nova AI on one governed stack, with LIMS on the roadmap—one identity, audit, and deployment philosophy so you are not re-integrating every time a new module ships.
Control planeAvailable
Novaqis Admin
Organizations, sites, users, roles, SSO, licensing, audit, and DMS migration—the backbone for segregation of duties across every module.
Product detailsDashboard / Dashboard
Dashboard
Operations overview
Last updated: 6/15/26, 12:55 PM
Users
13
Active: 14 · Inactive: 0
Sites
3
Active: 3 · Inactive: 0
Roles
8
Active: 8 · Inactive: 0
Active sessions
1
7 functional groups in scope
Daily sign-ins
Site distribution and logins use Admin data for your scope.
Document intelligenceAvailable
Novaqis DMS
Full GxP lifecycle: editor, workflows, change control, controlled print, training gates, access and destruction—with Part 11–aligned audit trails.
Product detailsDashboard / Dashboard
Dashboard
Document lifecycle overview
Documents by type
Standard Operating Pro…
9
Standard Operating Pro…
1
Status distribution
Total10
Under preparationRejectedPending approvalEffective
Needs your action
Tasks sorted by deadline — overdue first
DocumentTaskTime left
Operational visibilityAvailable
Novaqis Reporting
Session and lifecycle reports, operational dashboards, and trends — without risky exports or a separate BI login.
Product detailsDashboard / Reports / User Session Report
User Session Report
⌕Search by keywords
☰ FiltersExport ▾
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603
Total Sessions
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0
Active Sessions
●
10
Unique Users
●
7.7m
Avg Duration
Showing 1 - 25 of 603 records
| Username | Source | Status |
|---|---|---|
| DMS_User | DMS | LOGGED OUT |
| default | ADMIN | LOGGED OUT |
| DMS_User | DMS | LOGGED OUT |
Items per page: 25·1 – 25 of 603
Intelligent layerAvailable
Nova AI
Conversational guidance, document assist, and permission-scoped summaries in Admin, DMS, LMS, and QMS—plus reporting and OCR on the same security model.
Product detailsDashboard / Dashboard
Dashboard
←SOP-QA-0142 · Batch record reviewv3.0
4.2 Sampling frequency
QA shall recieve samples per batch prior to release testing. Document reference: FRM-QC-0204.
4.3 Deviation handling
Deviations outside specification limits require QA assessment within 24 hours.
People & competencyAvailable
Novaqis LMS
Curricula, assessments, ILT/OJT, document-linked retraining, and competency evidence on the same identity and controlled documents as DMS.
Product detailsDashboard / Dashboard
Dashboard
Recent activity
TypeTitleWhen
Quality eventsAvailable
Novaqis QMS
Configurable quality processes—deviation, CAPA, change control, audit, complaint, OOS/OOT, and management review—linked to DMS evidence and LMS training on one governed stack.
Product detailsDashboard / Dashboard
Dashboard
Recent quality records
Issue codeProcessCreated
Manufacturing & batch recordsAvailable
Novaqis BRM
Master formula records, electronic batch execution, line clearance, and e-logbooks—interlocked with DMS controlled-copy issuance and LMS training qualification.
Product detailsDashboard / Manufacturing
Dashboard
Recent batches
BatchProductLine
Audit intelligenceAvailable
Novaqis AuditLens
Cross-system entity trace, anomaly detection, audit lifecycle with e-sign, and license-scoped readiness for inspections—on the same identity fabric as the suite.
Product detailsIntelligence / Dashboard
Pre-inspection readiness
Scope: AUDITLENS · DMS · LMS · QMS · BRM
Pre-inspection readiness
Executive status
ACTION REQUIRED
Open audits
4
2 FDA · 1 Internal
Open findings
12
3 critical
Anomalies
7
Cross-module
Trace coverage
94%
Licensed modules
Entity trace — SOP-QA-0142
Live leaf calls[DMS]
SOP-QA-0142 v3.0 Effective
Published · training gate on
[LMS]
12 / 14 qualified readers
2 overdue retrainings
[QMS]
CAPA-2026-0088 linked
Root cause closed
[BRM]
Referenced in BCH-2026-0142
Issuance token verified
Anomaly findings
CRITICAL
Effective SOP without training
[LMS] Close overdue assignments
MAJOR
CAPA closed without doc revision
[DMS] Open change control
MINOR
Operator qual gap on Line 03
[BRM] Hold step until LMS gate
Laboratory informaticsRoadmap
Novaqis LIMS
Sample, test, and instrument workflows on the same identity and audit fabric as DMS and quality.
Products & roadmap hubRoadmap · In development
Planned for a future release
Laboratory workflows on the same identity and audit fabric.
Sample registrationTest methodsResults reviewInstrument links
UI preview not representative of final product
Novaqis LIMS · roadmap
Ready to map the full platform?
The full platform—Admin, DMS, LMS, QMS, BRM, AuditLens, Reporting, and Nova AI—with LIMS on the roadmap. Explore every module on one governed stack.
Start your free trial or speak with our team about flexible hosting options.
Let's talk
Shape your next validation win
Demos across Admin, DMS, LMS, QMS, Reporting, and Nova AI; security packs; vendor questionnaires; or a plain-spoken architecture walkthrough—tell us what you need. We answer with people who build the product. Download the platform brochure for a printable overview.
<24h
First reply
NDA-friendly
Security reviews
Live stack
Not slides-only
Direct line
Email or call—same team. Email is ideal for attachments and formal vendor processes.
Project enquiry
Start a conversation
Share company, sites, deployment preference (on-prem vs hosted), and what you want to validate first—we route it to the right engineer or sales lead.