Quality Connect

Quality Connect is an electronic Quality Management System (eQMS) built by Montrium for life sciences organisations operating in regulated environments. Designed by compliance and QA specialists with decades of industry experience, it centralises document control, training oversight, and quality event management into a single platform with automated workflows — eliminating the manual tracking that pulls teams away from their core clinical and quality work.

Quality Connect is purpose-built for quality governance leaders, QA managers, clinical operations teams, and compliance professionals across pharma, biotech, medical device, CRO, and non-profit life sciences organisations. It is trusted globally by teams who need real-time visibility into compliance status and audit-readiness without relying on spreadsheets or disconnected tools.

Automated Document Control

• Automated workflows route documents to the appropriate reviewers with task assignments and reminders, so teams always know which SOPs are awaiting approval, who is responsible, and how long items have been pending.
• Configurable review and approval workflows adapt to each organisation's processes.
• Task and reminder automation reduces the need for manual follow-up.
• Real-time collaborative authoring is supported natively, with integration of Microsoft Word's familiar features so users can author and edit SOPs directly within the system without switching to external editors or uploading files between tools.

Training Oversight and Compliance

• System-generated reports identify which employees have overdue training, replacing Excel-based tracking logs and eliminating uncertainty ahead of audits.
• A centralised, role-based training matrix provides a single source of truth for all training requirements across the organisation.
• Training gap identification and remediation workflows help teams address compliance shortfalls proactively.
• On-demand reporting means compliance status can be confirmed in minutes rather than hours, giving teams confidence when auditors arrive.

Quality Event Management

• Deviations, complaints, and CAPAs are tracked in one system rather than across email threads and spreadsheets, providing a unified view of every quality event.
• Intelligent event capture streamlines the intake of quality issues.
• Streamlined workflows and processes guide events through to closure consistently.
• Real-time KPIs and flexible reporting provide visibility into closure rates, trending issues, and overall quality system performance.

Reporting and Audit Readiness

• Training records, SOP status, and quality metrics can be pulled up on demand in minutes.
• System-generated reports surface compliance gaps before auditors identify them, enabling teams to walk into inspections with confidence.
• Montrium's Quality and Compliance team supports vendor assessment activities through a dedicated Help Center and Trust Center, hosts vendor audits, and provides compliance documentation during regulatory inspections.

Regulatory Compliance and Security

• Quality Connect is designed to meet the technical requirements of FDA 21 CFR Part 11 and EudraLex Volume 4 Annex 11, with features including document version history, comprehensive audit trails, record retention policies, secure system access, and electronic signature execution.
• For external signatures, Montrium offers Sign Validation services for Adobe Acrobat users.
• Cloud infrastructure is hosted on Microsoft Azure with data isolation, encryption in transit and at rest, and continuous monitoring aligned with SOC 2 standards; Montrium has completed a SOC 2 Type I audit.
• Additional compliance alignments include GDPR, ISO 9001:2015 QMS, and Annex 11 principles for data integrity and risk-based validation.
• Security practices include penetration testing, vulnerability scanning, code analysis, and thorough vetting of all personnel with access to sensitive data.

Quality Connect is deployed as a cloud-based platform and is accessible to remote employees. Workflow customisation is supported to match each organisation's quality processes. Montrium also offers complementary products including eTMF Connect and RegDocs Connect, making Quality Connect part of a broader connected platform for clinical and regulatory teams in life sciences.