eQMS Implementation & Onboarding
Yes. Grand Avenue Software is designed to scale alongside growing medical device companies. Its modular structure means companies can start with the modules they need and add functionality as their operations expand. The platform supports compliance with ISO 13485:2016, FDA 21 CFR Part 820, EU MDR 2017/745, and 21 CFR Part 11, making it suitable…
Grand Avenue Software offers onboarding services including setup, data migration, training, and customization. For more complex deployments, a network of trusted implementation partners provides comprehensive rollout services. Grand Avenue Software’s team works closely with every customer throughout the process to ensure a successful and compliant go-live.
Grand Avenue Software’s implementation assistance services are designed to accelerate deployment and audit readiness, covering system configuration, end-user training, data migration, and validation documentation. Every Grand Avenue Software system includes an Installation Qualification updated with each new release, along with detailed testing documentation. All plans include a fully validated, cloud-based eQMS with built-in electronic signatures…
Grand Avenue Software provides a comprehensive support ecosystem designed for small QA teams: fast, expert technical assistance, a robust FAQ catalog available on demand, a training materials library in video and PowerPoint formats, live training sessions through the Grand Avenue Software Learning Academy, and sandbox environments for safe training and testing. In-house implementation assistance is…
Yes. Grand Avenue Software supports a structured migration path: assess and clean up existing data, update QMS procedures to align with Grand Avenue Software’s module workflows, use the platform’s bulk upload feature to import documents, configure automated workflows, validate the system for compliance, and train the team. Grand Avenue Software’s in-house implementation assistance services also…
Compliance with ISO 13485:2016 is built into Grand Avenue Software out of the box. The platform includes built-in electronic signatures, audit trails, and controlled document workflows aligned with ISO 13485 requirements. Each system also includes an Installation Qualification updated with every new release, along with detailed testing documentation to support validation and certification readiness.
Onboarding for Grand Avenue Software typically takes 4 to 8 weeks, depending on the complexity of your organization’s needs and the modules being implemented. This includes initial setup and configuration, data migration, process customization, employee training, and testing and validation. Grand Avenue Software’s support team works closely with every organization to ensure a smooth and…