QMS

Octalsoft QMS is a centralized, AI-enabled clinical quality management system (CQMS) designed to digitize and streamline quality processes for enterprises, pharmaceutical organizations, biotech companies, and CROs. It is built to help organizations meet regulatory compliance requirements and maintain operational quality standards across clinical trial workflows.

The platform functions as both a standalone enterprise solution and as part of Octalsoft's broader eClinical suite, integrating with CTMS, eTMF, HRMS, and Analytics modules to provide a unified source of truth for quality and compliance data.

Core Capabilities

• Document and SOP Management: Provides a centralized repository for policies, standard operating procedures, and controlled documents. Supports automated version control and approval workflows, and maintains audit-ready documentation at all times.
• CAPA (Corrective and Preventive Actions): Tracks and manages corrective and preventive actions across teams and functions. Includes automated workflows with real-time status tracking to ensure accountability and resolution within defined timelines.
• Regulatory and GxP Compliance: Supports compliance with FDA 21 CFR Part 11, GCP, GMP, ISO, and GDPR. Maintains complete audit trails with electronic signatures and prepares organizations for sponsor, CRO, and regulatory audits.
• Risk and Change Management: Uses AI-powered risk assessment for processes and documentation. Includes change control workflows with impact analysis and proactive alerts for deviation handling and escalation.
• Training and Competency Management: Assigns, tracks, and evaluates staff training requirements. Ensures team compliance with GCP, GMP, and SOP-specific protocols, with integration into Octalsoft HRMS for unified staff training records.
• Audit and Inspection Management: Schedules and tracks internal, external, and regulatory audits. Generates audit-ready reports with full traceability and supports communication with inspectors and stakeholders.

Role-Based Benefits

• Business Leaders: Supports governance, reduces operational risk, and helps enforce global quality standards across teams.
• Clinical Operations: Aligns trial processes with GCP and sponsor expectations, reducing delays and inspection risks.
• Quality Teams: Automates quality workflows, tracks CAPAs, and provides oversight through centralized dashboards.
• Employees: Provides straightforward access to SOPs and assigned training tasks to support individual compliance.

Add-ons and Integrations

• Octalsoft HRMS: Integrates training records and certifications directly with QMS compliance requirements.
• Octalsoft eTMF: Aligns QMS records with trial master files to support inspection readiness.
• eClinical Suite: Connects with CTMS, eTMF, HRMS, and Analytics for end-to-end clinical trial quality management across pharma, biotech, and CRO environments.

Platform Characteristics

• Designed to meet global regulatory standards including 21 CFR Part 11, GCP, and GDPR.
• Built with domain expertise oriented toward the needs of CROs, sponsors, and clinical sites.
• Covers the full trial lifecycle from planning and operations to data capture and analytics.
• Includes personalized onboarding, 24/7 support, and ongoing optimization services.

Octalsoft QMS is available as a standalone deployment or as part of the integrated eClinical suite, making it applicable across a range of organizational sizes and trial types in the pharmaceutical, biotechnology, and contract research sectors.