Quality Management System

Streamline Operations and Ensure Compliance with a Complete, Integrated Platform

Scigeniq QMS is a comprehensive, cloud-based quality management system designed specifically for the evolving needs of life sciences companies.

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QMS Product

Ensure Compliance. Improve Efficiency. Accelerate Growth.

Scigenig QMS is an integrated platform designed to help life sciences companies streamline quality processes, meet global regulatory requirements, and bring products to market faster. With a cloud-based, configurable system, you can manage audits, CAPAs, deviations, supplier qualifications, and more—all in one place.

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Stay Compliant with Ease

Meet FDA, Anvisa, and global regulatory standards (GMP, GLP, GCP) while minimizing compliance risks.

Audit & Inspection Management – Track and document internal and external audits.

Automation

Boost Efficiency & Reduce Errors

Automate quality processes to eliminate manual work, improve consistency, and reduce variability.

Deviation & Non-Conformance Management – Capture, investigate, and resolve quality issues.

Accelerate Time-to-Market

Simplify approvals and enhance collaboration between R&D, manufacturing, and quality teams.

Audit & Inspection Management – Track and document internal and external audits.

Strengthen Supplier & Customer Relationships

Ensure quality across the supply chain and quickly resolve customer complaints.

Audit & Inspection Management – Track and document internal and external audits.

Complaint & Adverse Event Handling – Track, investigate, and resolve complaints.

QMS

Ensure a Trained, Audit-Ready Workforce

Keep employees up to date with automated training management and compliance tracking.

Training Management – Assign, track, and report on SOP and regulatory training.

Key Features

Scigeniq QMS is an integrated quality system that includes a huge range of capabilities and features to ensure compliance and streamline operations.

Change Control

Track and manage changes to processes, documents, and equipment while ensuring regulatory compliance.

CAPA Management

Automate Corrective and Preventive Actions (CAPA) to systematically resolve quality issues.

Audit & Inspection Management

Schedule, track, and document internal and external audits, including regulatory inspections.

Manage Deviation & Non-Conformance

Capture, investigate, and resolve deviations in manufacturing, testing, and quality processes.

Training Management

Ensure employees complete required training on SOPs and regulatory guidelines, with automated tracking and reporting.

Complaint & Adverse Event Handling

Track, investigate, and resolve customer complaints and adverse events.

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