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Quality management
Novaqis QMS is a pharmaceutical quality management system (eQMS) for GxP sites. Manage deviations, CAPA, change control, and investigations with electronic signatures and ALCOA+ trails—connected to controlled documents, training, LIMS OOS escalation, and manufacturing holds on one Novaqis stack.
Dashboard / Dashboard
Dashboard
Recent quality records
At a glance
Enterprise Architecture
Deterministic architectures and automated compliance engines engineered for multi-plant pharma operations.
Multi-batch consolidation and real-time statistical process capability analysis: computes Cp, Cpk, Ppk, and Process Sigma Z-scores across commercial batches with 21 CFR Part 11 electronic sign-off.
Govern Class I, II, and III recalls with live statutory 48-hour SLA countdown timers, consignee distribution tracking, live ≥ 98.0% reconciliation recovery gauges, and dual Quality/Regulatory Head closure sign-off.
Direct bridge from Novaqis LIMS: ingests Phase I lab investigation findings, auto-initializes DEV-YYYY-OOS records, assigns 15-day SLA work items, and binds CAPA evaluation workflows.
Deviations, investigations, CAPA, change control, audits, complaints, lab and supplier themes, and more, organized so investigators see the full picture.
Get a head start on workflow wording and assessment questions. People still review, approve, and sign before anything goes live.
Close critical steps with the electronic signature rules your SOP requires, clear accountability, not a single casual click.
Log, investigate, act, and check effectiveness with a trail that stands up when someone asks what happened next.
Change work can consider document impact so controlled content and quality decisions do not live in separate worlds.
When quality says people need retraining, assignments can flow into LMS, so effectiveness is not a checkbox without evidence.
When manufacturing records are part of your Novaqis suite, open quality holds can stop a release until the issue is resolved, QA and the plant share one truth.
Invite suppliers or partners to share attestations and evidence under controlled access, without inventing a parallel user world.
Same login, sites, and licensing as Admin and DMS, add quality without starting a new vendor narrative.
In the product
Manage deviations, non-conformances, and market complaints with automated risk matrices, structured 5-Why and Ishikawa root cause trees, and bidirectional links to DMS SOPs and LMS training.
Part 11
Audit-ready trails
CAPA
Deviation & effectiveness
Config
Forms & workflows
Suite
DMS + LMS traceability
Quality Event Governance & Deviation Oversight
Dashboard / Dashboard
Dashboard
Recent quality records
2-Phase Investigation & 5-Why CAPA Trees
Dashboard / Dashboard
Dashboard
Recent quality records
Capability depth
Novaqis QMS is the central nervous system for life-sciences quality operations: out-of-the-box 2-phase OOS lab-to-manufacturing escalation, 5-Why root cause trees, risk-based change controls, automated Annual Product Quality Reviews (PQR) with real-time process capability analytics (Cp, Cpk, Ppk), and Class I/II/III product recall governance with automated reconciliation gauges.
Quality events
Quality teams often stitch deviations, CAPA, and change control across email, spreadsheets, and document tools. Novaqis QMS keeps that work configurable, and connected to documents, training, and manufacturing.
Rigid templates or custom code per process.
Configure forms and workflows to your SOPs.
What to try in a pilot
+2 more evaluation items in the full comparison - expand above.
Quality in one system; evidence hunted elsewhere.
Documents, training, and holds in one conversation.
What to try in a pilot
+2 more evaluation items in the full comparison - expand above.
Separate QMS vendor; duplicate identity.
Shared Admin and licensing; run where you need.
What to try in a pilot
+2 more evaluation items in the full comparison - expand above.
Categories describe common market patterns, not any specific vendor. Your process design and validation scope decide fit.
Regulatory alignment
Market Benchmarks
Technical Research
Talk to our team about how Novaqis QMS fits your validation and compliance requirements.
FAQ
