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QMS

Issue processing, management, and oversight for clinical trials with incident logging, investigations, CAPAs, and audit tracking.

Solution by Trial Interactive
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Overview

Trial Interactive's Quality Management System (QMS) is a configurable and connected clinical quality management solution designed to help life sciences organizations securely track and manage all aspects of quality oversight in clinical trials. The platform is built for sponsors, CROs, and other stakeholders who need to maintain global compliance while efficiently handling incident and complaint logging, case investigations, corrective and preventive actions (CAPAs), compliance documents, and audits.

By automating quality issue intake, collection, processing, approval, and reporting activities, Trial Interactive's QMS ensures continuous regulatory compliance while reducing the administrative burden on quality teams. The system is part of a broader modular platform, enabling organizations to consolidate quality management alongside other clinical operations under a single vendor.

Core Quality Management Capabilities

  • Incident and complaint logging with structured intake and processing workflows
  • Case investigation management and processing tools
  • CAPA (Corrective and Preventive Action) tracking and oversight
  • Compliance document management with controlled document workflows
  • Audit management and tracking

Key Benefits of a Connected QMS

  • Animated, controlled document workflows that guide users through each quality process step
  • Full transparency between related issues, CAPAs, actions, and tasks to maintain end-to-end visibility
  • Real-time alerts and tracking to keep stakeholders informed of quality events as they occur
  • Full audit trail and version control to support regulatory inspections and compliance reviews

Platform and Operational Advantages

  • Controlled access for stakeholders, ensuring appropriate visibility and permissions across teams
  • Process transparency and efficiency through centralized management of all quality activities
  • Reduced costs through central management and oversight, eliminating the need for disparate point solutions
  • Highly configurable and flexible to meet the specific needs of different organizations and trial types

Trial Interactive's QMS is delivered as part of a unified, modular platform that also encompasses eTMF and TMF services, content management, trial management, and learning management — enabling organizations to manage the full scope of clinical operations through a single vendor relationship.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic ProfessionalIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP