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Modular. Configurable. Scalable.
Grand Avenue Software provides the industry-leading quality management software solution for medical product companies. We are the affordable, scalable, and efficient eQMS deployed by med-tech innovators and leaders around the world. Our team has extensive experience in software development, Software as a Service (SaaS) delivery, and quality compliance, specifically for the life sciences industries.
We work hand-in-hand with startups, emerging growth and established companies to navigate the complex regulatory affairs (RA) and quality assurance (QA) environment. With Grand Avenue, compliance is assured, your budget is preserved.
Our Solution Suite
Design & Development
Design Control
Manage and track design projects through the lifecycle phases. Manage the electronic Design History File (DHF).
Risk Management
Identify hazards and harms associated with the medical device. Estimate, evaluate, mitigate, and control associated risks.
Documents & Training
Document Control
Submit, route, approve, and implement electronic document changes and deviations.
Training Management
Define and manage training requirements. Authorize users for read-and-understand training. Certify a training requirement. Measure training effectiveness.
Training Assessment
Extends the Training Management module to use tests/quizzes to assess a user’s understanding of the completed training.
Quality Systems
Audit Management
Manage internal, supplier, and external audits. Record findings, observations, and resolutions.
CAPA
Manage corrective, preventive, and supplier requests. Track detailed root-cause analysis, action plans, and verification of results.
Complaint Handling
Capture, track, and manage product/service issues. Prioritize, investigate, report, and trend complaints.
Nonconforming Materials
Identify, quarantine, disposition, track, and trend product nonconformances.
Equipment Management
Manage equipment calibration, maintenance and qualification activities, and unplanned events.
Supplier Management
Review and approve suppliers. Manage the Approved Supplier List (ASL). Define, Manage, and schedule supplier controls.
Enterprise Integrations
Authentication Management
Grand Avenue’s Authentication Management provides support for single sign-on (SSO) authentication within Grand Avenue.
Business Advantages
System Capabilities
The Grand Avenue solution suite meets your compliance needs, fits within your budget, and delivers clear and timely business value.
