21 CFR Part 11
Electronic records & signatures
GxP · 21 CFR Part 11 · EU Annex 11
Regulated operations software for pharma, biotech & GMP
Novaqis is a regulated-operations platform: a growing suite of solutions for pharma, biotech, and GMP—not a narrow point product. Live today: Admin, DMS, Reporting, and Nova AI. Roadmap & in flight: LMS, QMS, LIMS, and batch & production records (BRM)—and more as the portfolio expands. Built by people who have delivered and operated large-scale GxP quality and document platforms for years—the same category of systems on most enterprise shortlists. No third-party dependency wall. Fully on-premise capable. We believe a disciplined POC shows a clear generational advantage—see for yourself.
Evaluating enterprise GxP document or quality suites? How we approach side-by-side comparisons—independence, trademarks, and what we think you should test.
Multi-solution regulated platformAdd lab, QMS, BRM without replatformingNo Microsoft Word requiredAI + reporting across governed data
app.novaqis.com/dms
+ New Document
47
Effective
12
In Review
5
Pending
SOP-QA-0042 Batch Release
WI-PROD-0018 Cleaning Proc.
POL-RA-0009 Risk Assessment
SOP-IT-0003 Access Control
21 CFR Part 11 • EU Annex 11
Novaqis DMS100%On-premise deployable
21 CFRPart 11 ready
<2sAI response time
GxPValidated framework
Compliance
Designed for regulated environments
EU Annex 11
Computerised systems
ALCOA+
Data integrity mindset
Private deploy
Your infra, your control
Solutions
Many regulated workflows. One platform philosophy.
From documents and governance to lab and production records on the roadmap—Novaqis is designed as an expanding suite. Add modules without ripping out identity, audit, or deployment every time.
Documents & records
From migration to governed print - GxP document control in the suite.
Beyond shared drives and Excel-only bulk templates: OCR- and AI-backed capture from real documents auto-fills much of bulk metadata with a review queue for exceptions; optional tooling pulls from your existing DMS for traceable import. Controlled printing, and paperless exams, surveys, and SOP checklists sit alongside authoring, review, approval, and ALCOA+-style trails.
OCR & AI bulk captureLegacy DMS importControlled printPaperless attestations
Platform & governance
Identity, licensing, and policy that every other solution plugs into.
Organizations, sites, users, roles, and product entitlements stay consistent across modules - so you validate a platform, not a fragile integration map every time you add a capability.
Segregation of dutiesMulti-site pharmaOffline-capable licensingOne control plane
Intelligent automation
AI scoped by your access rules - not a shadow IT chatbot.
OCR, natural-language reporting, and fast answers grounded in governed data: acceleration without punching holes in quality culture. Extensible as more modules join the suite.
NL-to-SQLSub-second OCRRole-awareOn-prem friendly
Visibility & evidence
Reporting that doesn't force exports or back-door database access.
Operational dashboards and event-oriented analytics for leaders and QA - traceability and audit narrative without leaking regulated data to unmanaged BI tools.
Real-time signalsSoD-friendlyAudit evidenceNo spreadsheet sprawl
Laboratory (roadmap)
LIMS-class workflows on the same platform story.
We are building toward laboratory informatics that shares identity, documents, and audit vocabulary with the rest of the suite - so lab data and quality records don't live in disconnected silos.
Samples & workflowsInstrument integration themesGxP alignmentDesign partners
Production records (roadmap)
Batch & production records (BRM) connected to controlled content.
Roadmap direction: electronic batch records and manufacturing execution patterns tied to the same governed documents, training, and quality events - reducing paper and reconciliation drag.
EBR themesLine clearanceExceptions & QASuite roadmap
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
No Microsoft Word subscription needed. Author, review, and approve SOPs entirely inside Novaqis — with tracked changes, controlled versioning, and e-signature built in.
Modern, intelligent stack
Built on .NET 9, SignalR real-time, Redis caching, and Nova AI — OCR, natural-language reporting, and smart search grounded in your governed data.
Multi-platform & load-balanced
Web, desktop, and mobile. Horizontal scaling out of the box — load-balancer ready with Docker orchestration. Larger user bases, zero headaches.
Security & governance first
Offline asymmetric licensing (ES256), AES-256 data encryption, role-based access, ALCOA+ audit trails, and 21 CFR Part 11 / EU Annex 11 electronic signatures.
Lightweight & efficient
Optimised resource usage means you run more on less infrastructure. Startup-friendly operational overhead, without sacrificing enterprise capability.
Product portfolio
A regulated-ops suite — not a single point solution.
Novaqis is a regulated-operations platform: multiple live solutions today, with a deliberate roadmap across quality, lab, training, and manufacturing records—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, and product licensing — the backbone that keeps segregation of duties consistent across every module.
Product detailsNovaqis Admin
Document intelligenceAvailable
Novaqis DMS
GxP document lifecycle, workflows, electronic signatures, and audit-ready records for pharma, biotech, and GMP manufacturing.
Product detailsNovaqis DMS
Operational visibilityAvailable
Novaqis Reporting
Dashboards and event-oriented analytics inside governed boundaries — traceability without risky exports or back-door database access.
Product detailsNovaqis Reporting
Intelligent layerAvailable
Nova AI
OCR, natural-language to SQL, and fast answers grounded in your roles and data — scoped so AI accelerates quality, never undermines it.
Product detailsNova AI
People & competencyRoadmap
Novaqis LMS
Training assignments, curricula, and competency evidence tied to the same identity and controlled documents — on the roadmap with design partners.
Product detailsNovaqis LMS
Quality eventsRoadmap
Novaqis QMS
Deviations, CAPA, and change control linked to governed records — planned to complete the suite alongside DMS and LMS.
Product detailsNovaqis QMS
Laboratory informaticsRoadmap
Novaqis LIMS
Sample, test, and instrument workflows on the same identity and audit fabric as DMS and quality—so lab operations are not a disconnected island.
Products & roadmap hubNovaqis LIMS
Manufacturing & batch recordsRoadmap
Batch & production records (BRM)
Electronic batch records and production execution patterns tied to controlled documents and training—reducing paper, reconciliation, and swivel-chair QA.
Products & roadmap hubBatch & production records (BRM)
Ready to map the full platform?
Live modules plus a roadmap across quality, training, lab, and production records—explore what ships today and what we are building next, all 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, security packs, vendor questionnaires, or a plain-spoken architecture walkthrough—tell us what you need. We answer with humans who build the product, not a ticket black hole.
<24h
First reply
NDA-friendly
Security reviews
Live stack
Not slides-only
Direct line
contact@novaqis.comPrefer email? Same team—ideal for attachments and formal vendor processes.
We speak your roadmap
- Live modules: Admin, DMS, Reporting, and Nova AI
- On the roadmap: LMS, QMS, LIMS, and batch & production records (BRM)
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.