Implementation and Support
Accelerate your implementation with Grand Avenue. Our powerful software and expert services streamline deployment, ensuring faster compliance and operational efficiency.
Out Of The Box Functionality
Functionality for compliance is built into our product. The Grand Avenue modules are developed for companies who need to comply with:
- ISO 13485:2016
- 21 CFR/Part 820 QMSR
- EU MDR 2017/745
- 21 CFR/Part 11
How It Works
1 Kickoff call
We start with a kickoff call to review the implementation plan and confirm scope and timeline while your environments are being set up in the background.
2 Configure the system
Guided weekly sessions walk through each module hands-on, so your team arrives at go-live fully capable and confident.
3 Migrate your data
We walk you through the migration process from start to finish — you own your data and control every step.
4 Validate the system
Every implementation includes a full validation package for your environment — User Requirements Specification, Risk Analysis, Validation Report, acceptance testing docs and checklists.
5 Go live and expand as needed
Launch with a capable team and a validated system. Grand Avenue’s support team, knowledge hub, sandbox environments, and ongoing training are there whenever you need them.
Capabilities and Services Making This Possible Include:
Get fast, expert assistance from our support team to ensure seamless implementation and ongoing success.
Answers to commonly asked implementation and support questions are available on demand in the FAQ database.
A robust library of training materials is available on demand. Implementation and user knowledge is provided in video and PowerPoint formats.
Live training sessions are offered via web meeting at scheduled intervals. All Grand Avenue customers are welcome to attend each session.
All customers have access to learning or “sandbox” systems, providing safe environments to try new things, train new team members, and evaluate new system capabilities.
Each Grand Avenue system includes an Installation Qualification, updated with every new release, along with detailed testing documentation.
Implementation Assistance Services
In-house services are available to perform a variety of implementation tasks leading to rapid deployment. This include any combination of these services:
Implementation with Trusted Partners
Grand Avenue’s trusted partners provide comprehensive services to streamline deployment, ensuring a smooth, compliant eQMS rollout.
Find a partner to accelerate your success.
eQMS Implementation & Onboarding: Frequently Asked Questions
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’s support team works closely with every organization to ensure a smooth and successful implementation.
Compliance with ISO 13485:2016 is built into Grand Avenue 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.
Yes. Grand Avenue supports a structured migration path: assess and clean up existing data, update QMS procedures to align with Grand Avenue’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’s in-house implementation assistance services also include direct data migration support as part of the deployment process.
Grand Avenue 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 Learning Academy, and sandbox environments for safe training and testing. In-house implementation assistance is also available, covering system configuration, end-user training, data migration, and documentation.
Grand Avenue’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 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 and audit trails from day one.
Grand Avenue 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’s team works closely with every customer throughout the process to ensure a successful and compliant go-live.
Yes. Grand Avenue 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 for companies operating across multiple regulatory markets. Its cloud-based architecture supports international operations without added infrastructure.