Configurable quality workflows
Design forms and routes for how your site operates. Changes stay governed and signed, without waiting months for a vendor release to match reality.
Solution · Enterprise Quality Management (eQMS)
Best Pharma QMS & eQMS Software: Deviations, CAPA & Change Control (21 CFR Part 11)
2-Phase OOS/deviation investigations, 5-Why & Ishikawa root-cause trees, CAPA effectiveness, and change control
Quality teams need an eQMS that matches how investigations actually run, not a rigid ticket system with a GxP label. Novaqis QMS helps you configure deviations, 2-phase investigations (5-Why & Ishikawa fishbone trees), CAPA effectiveness checks, and change control directly linked to DMS SOPs, LMS training, and BRM batch records on one audit fabric.
- 21 CFR Part 11 themes
- GxP eQMS
- EU Annex 11 aligned
- Configurable to site SOPs
Product preview
See it in the platform
Open deviations, CAPA due, and change queues
Dashboard / Dashboard
Dashboard
Recent quality records
Issue codeProcessStatusCreated
Capabilities
What you get
Deviation & CAPA with full context
Investigators see linked documents, training status, and batch impact in one place, fewer swivel-chair reconciliations at closure.
Change control connected to DMS
Quality changes that touch controlled documents propagate through the same identity and audit model as your document lifecycle.
Audit & inspection programs
Plan internal audits, track findings, and connect evidence across licensed modules before external visitors arrive.
Nova AI for quality authors
Accelerate wording and assessment drafts under the same permission model, reviewers still approve and sign before go-live.
Compliance & control
Built for regulated operations
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
CapabilityHow Novaqis delivers it
- Audit trails on quality records
Every state change on deviations, CAPA, and change records captures user, timestamp, and reason for ALCOA+ inspection narratives.
- Electronic signatures
Meaning-of-signature prompts on approvals and closures aligned to common pharma validation packages.
- Role-based access control
Investigator, approver, and quality-admin roles scoped by site and program, shared with Admin and DMS identity.
- Document & training linkage
See controlled document versions and LMS qualification status inside quality records without exporting to spreadsheets.
- On-prem & private cloud
Deploy inside your network for data residency and validation boundaries your IT and QA teams accept.
Outcomes
Why teams choose Novaqis
- Processes that feel like your site, not a generic template
- Faster closure with linked document and training context
- One login story with DMS, LMS, and BRM
- Inspection-ready quality narratives across modules
FAQ
Frequently asked questions
- Novaqis QMS is built for regulated pharma workflows, governed forms, e-signatures, audit trails, and links to controlled documents and training. Generic ITSM tools rarely provide the validation evidence and lifecycle integration QA teams need for GxP inspections.