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InnoQualis Documentation

Complete user guide for the Enterprise Quality Management System

InnoQualis is a comprehensive Enterprise Quality Management System designed for regulated industries. It provides end-to-end quality management including document control, training management, deviation handling, CAPA, audit management, and more — all with full audit trail and electronic signature support.

Document Control

Create, review, approve, and manage controlled documents with full version history. Go to Documents

Training Management

Assign training, track completion, manage competency assessments and requalification. Go to Training

Deviations

Report, investigate, and resolve deviations with root cause analysis and risk assessment. Go to Deviations

CAPA

Create corrective and preventive actions, track action items, and verify effectiveness. Go to CAPA

Change Control

Manage change requests through impact assessment, approval, and implementation. Go to Change Control

Audit Management

Plan audits, record findings, and track resolution through to closure. Go to Audits

Equipment Management

Track equipment, calibration schedules, and maintenance records. Go to Equipment

Supplier Management

Manage supplier qualification, classification, and performance monitoring. Go to Suppliers

SCARs

Issue and track Supplier Corrective Action Requests. Go to SCARs

Complaints

Log, investigate, classify, and resolve product complaints. Go to Complaints

Electronic Signatures

Sign, verify, and manage 21 CFR Part 11 compliant electronic signatures. Go to Signatures

  • Role-Based Access Control — Granular permissions ensure users only see and do what their role allows.
  • Full Audit Trail — Every action is logged with timestamps and user identity for regulatory compliance.
  • Electronic Signatures — 21 CFR Part 11 compliant signatures with verification and meaning statements.
  • AI Assistant — Built-in AI assistant for compliance guidance, document drafting, and quality insights.
  • Real-Time Dashboard — KPIs, compliance scorecard, risk heatmap, and deadline tracking at a glance.
  • Notifications — Configurable alerts for approvals, assignments, deadlines, and status changes.
  • Global Search — Find documents, deviations, CAPAs, training records, and more from a single search bar.
  • Dark Mode — Full light and dark theme support for comfortable use in any environment.