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GxP Validated21 CFR Part 11EU Annex 11

Novaqis DMS

GxP document lifecycle in your perimeter

Novaqis DMS delivers controlled documents, workflows, training-aware states, and auditability—with AI-assisted bulk capture from real files (not just Excel rows), optional legacy-DMS import, controlled printing, and room to run exams, surveys, and SOP checklists in the same paperless story.

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At a glance

OCR+AIBulk smart capture

DMS→Legacy import path

PrintControlled output

PaperlessExams & checklists

Why Novaqis DMS

Platform capabilities grounded in how you validate and operate

The points below map to real architecture and delivery choices—not generic marketing bullets.

Built-in WYSIWYG document editor

Syncfusion Document Editor: rich text, tables, images, track changes, and comments—import DOCX/RTF and export PDF/DOCX via a dedicated Document microservice, not a fragile desktop dependency.

Document service & object storage separation

Heavy document processing runs outside the core DMS API with MinIO-style object storage and swappable abstractions—so you can scale storage and processing independently.

Configurable workflows & training-aware states

Document lifecycle, review, approval, and effective/obsolete transitions align with your SOPs; training-aware states help ensure “effective” means the right people are qualified.

Per-document ALCOA+ style audit evidence

Audit trails for open, edit, save, import, and export—plus version snapshots—support data-integrity narratives for 21 CFR Part 11 and EU Annex 11–aligned validation.

In-app PDF viewing & e-signatures

View controlled PDFs in context, with electronic signatures and workflow steps that map to meaningful approval—not decorative clicks.

Enterprise throughput patterns

RabbitMQ-friendly async processing and service boundaries suited to high-volume regulated sites—without turning the document store into an ungoverned file share.

AI & OCR bulk onboarding with human review

Upload document images or PDFs at scale: OCR and intelligent extraction propose field values so bulk metadata entry is largely auto-filled; QA reviews and fixes exceptions in a queue—reducing the transcription errors that spreadsheet-only templates invite.

Legacy DMS retrieval & controlled import

Directional tooling to pull metadata and content from your existing document platform and map it into Novaqis—so migration is traceable and repeatable, not a manual re-keying marathon between systems.

Paperless exams, surveys & SOP checklists

Run training assessments, surveys, and SOP follow-through checklists in the same governed environment as controlled documents—so completion evidence is electronic, attributable, and inspectable instead of scattered paper or ad-hoc forms.

Advanced controlled-print policies

Printing is governed: watermarks, controlled-copy behavior, and policy tied to roles and document state—so “Print” is not an unlogged escape hatch from your validation story.

Capability depth

GxP-grade document lifecycle—from intelligent migration to governed print

DMS is built for teams who live in SOPs, change control, and inspections: controlled authoring, review, approval, training linkage, and retrieval—with electronic records and signatures that map to how you validate. It also addresses what many programs still do badly: bulk onboarding without spreadsheet-only risk, pull-through from legacy repositories, paperless attestations, and print control that does not bypass audit.

Authoring & lifecycle

In-browser WYSIWYG editing (Syncfusion Document Editor) with track changes, comments, and structured content—not a dependency on Microsoft Word for daily work
Document states, versioning, effective/obsolete handling, and periodic review aligned to your quality procedures
Configurable workflows for review, approval, and e-signature steps with meaning tied to your SOPs
Training-aware states so “effective” reflects both document release and qualification to use the content

Evidence, retrieval & integrity

Audit trails and history that stand up to QA and regulator scrutiny—including per-document activity for open, edit, save, import, export
Search and navigation tuned for regulated content, not consumer file apps
Document microservice and object storage separation—scale processing and storage without overloading the core API
Deployment inside your perimeter: data residency stays under your control

From paper & spreadsheets to governed digital records

Structured migration path for organizations moving binders, scans, and informal file shares into a single controlled repository with lifecycle, training linkage, and signatures—not a one-time “dump and hope” project.
OCR-backed, AI-assisted bulk onboarding: bring real document images or PDFs; the platform proposes structured field values so most metadata is auto-filled from what the document actually says. Your team monitors a review queue to correct edge cases—cutting the re-keying load that drives errors.
Compared with Excel-template bulk loads alone: spreadsheets are brittle for regulated metadata at volume (wrong column, stale pick-lists, formula mistakes). Intelligent capture from source documents ties fields to evidence you can defend in audit.

Paperless operations, controlled print & legacy coexistence

Designed for a fully paperless operating model where practical: examinations, training surveys, SOP follow-through checklists, and attestations can live alongside controlled documents—so completion evidence stays in the same audit fabric instead of parallel paper sign-in sheets or shadow tools.
Advanced printing controller for controlled documents—policies for watermarks, controlled-copy numbering, role-based print permission, and traceability that generic “browser Print” cannot enforce.
Legacy DMS bridge: tooling direction to retrieve metadata and content from your incumbent document system and map it into Novaqis—so cutover is a governed migration, not a manual re-entry project.
Many regulated teams still struggle with weak bulk-ingestion UX, print governance, and automated pull-through from older repositories—we treat those gaps as product priorities, not afterthoughts.

Regulatory alignment

Built for inspections from day one

21 CFR Part 11EU Annex 11 / GMPALCOA+ data integrityValidated deployment

Ready to see Novaqis DMS in action?

Talk to our team about how Novaqis DMS fits your validation and compliance requirements.

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