Everything in one place, with visibility into what needs attention. Quality Connect centralizes document control, training oversight, and quality event management with automated workflows that eliminate the manual tracking, freeing you to focus on real work.
Designed by compliance and QA specialists with decades of experience in regulated life sciences environments.
Automated workflows route documents to reviewers with task assignments and reminders. You know which SOPs are waiting for approval, who needs to review, and how long they've been pending.
System-generated reports show which employees have overdue trainings. No more Excel trackers or wondering if your team is compliant when an audit is announced.
Quality events are tracked in one system instead of across email threads and spreadsheets. See the status of every deviation, complaint, and CAPA. Real-time KPIs and flexible reporting provide visibility into closure rates, trending issues, and overall quality system performance.
Automated workflows route documents to reviewers with task assignments and reminders. You know which SOPs are waiting for approval, who needs to review, and how long they've been pending.
System-generated reports show which employees have overdue trainings. No more Excel trackers or wondering if your team is compliant when an audit is announced.
Quality events are tracked in one system instead of across email threads and spreadsheets. See the status of every deviation, complaint, and CAPA. Real-time KPIs and flexible reporting provide visibility into closure rates, trending issues, and overall quality system performance.
Pull up training records, SOP status, and quality metrics in minutes. System-generated reports show compliance gaps before auditors find them, so you walk into audits confident instead of stressed.
Quality Connect integrates Microsoft Word's native features, enabling teams to collaborate seamlessly when authoring and editing SOPs. Users can work directly within the system, eliminating the need to switch to external editors or upload files between tools.
Our Quality and Compliance team supports your vendor assessment activities through a dedicated Help Center and Trust Center. We provide resources and guidance to streamline evaluations, host vendor audits, and answer questions about our processes, helping you demonstrate that your system meets regulatory requirements.
Quality Connect is designed to meet the technical requirements of 21 CFR Part 11 and EudraLex Volume 4 Annex 11. With features like document version history, audit trails, record retention policies, secure system access, and electronic signature execution, it provides the tools you need to support compliance. For external signatures, Montrium offers Sign Validation services for Adobe users to get you validated in weeks.
We've seen results in the form of reduced costs, time, and effort relative to training and documenting training. This was previously tracked with Excel spreadsheet training logs. Quality Connect allows one employee to manage the trainings and SOPs.
Increase in efficiency of the SOP approval process.
Montrium protects customer data through rigorous security measures and compliance practices. All personnel with access to sensitive data are thoroughly vetted, maintain strict confidentiality, and receive ongoing security training. Testing protocols include penetration testing, vulnerability scanning, and code analysis. Cloud environments leverage Microsoft Azure's security features with data isolation, encryption in transit and at rest, and continuous monitoring aligned with SOC 2 standards.
FDA 21 CFR Part 11
Montrium systems meet FDA 21 CFR Part 11 requirements through secure user access, comprehensive audit trails, and electronic signatures that are uniquely assigned, securely linked to records, and protected against unauthorized use.
EudraLex Volume 4 Annex 11
Montrium products align with Annex 11 principles for computerized systems in GMP-regulated environments. Solutions support data integrity standards, provide secure audit trails, and enforce strict access controls through a risk-based validation approach.
SOC 2® Type I
Montrium successfully completed the AICPA SOC 2 Type I audit, confirming our information security practices meet SOC 2 standards for security.
Audit support
Montrium facilitates vendor qualification audits through transparent access to documentation and compliance evidence. We also support customers during regulatory inspections by supplying compliance documentation and responding promptly to inquiries.
ISO 9001:2015 QMS Alignment
Montrium's Quality Manual and procedural documents satisfy ISO 9001:2015 requirements for quality documentation, policy, and objectives.
GDPR
Montrium has implemented appropriate technical and security processes to ensure GDPR compliance.
“We really wanted a company to partner with who had that experience in our space, who understood the industry that we're in, and who understood that we're a small company in the process of growing.”
See how Quality Connect helps you stay proactive with automated workflows and real-time compliance visibility.
Find answers to common questions about Montrium's eQMS and its functionalities.
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