Grand Avenue Solution Suite
Quality compliance delivered through an integrated suite of web-based applications.
Audit Management
Manage internal, supplier, and external audits. Record findings, observations, and resolutions.
Authentication Management
Grand Avenue’s Authentication Management provides support for single sign-on (SSO) authentication within Grand Avenue.
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.
Design Control
Manage and track design projects through the lifecycle phases. Manage the electronic Design History File (DHF).
Document Control
Submit, route, approve, and implement electronic document changes and deviations.
Equipment Management
Manage equipment calibration, maintenance and qualification activities, and unplanned events.
Nonconforming Materials
Identify, quarantine, disposition, track, and trend product nonconformances.
Risk Management
Identify hazards and harms associated with the medical device. Estimate, evaluate, mitigate, and control associated risks.
Supplier Management
Review and approve suppliers. Manage the Approved Supplier List (ASL). Define, manage, and schedule supplier controls.
Training Assessment
Extends the Training Management module to use tests/quizzes to assess a user’s understanding of the completed training.
Training Management
Define and manage training requirements. Mark training complete. Authorize users for read-and-understand training. Certify a training requirement. Measure training effectiveness.
Proven Effective Efficient
Grand Avenue delivers clear business value for compliance and quality assurance.
Frequently Asked Questions
Yes, Grand Avenue Software provides strong security measures like encryption, access control, and audit trails, ensuring data protection and compliance with industry standards such as ISO 13485 and FDA 21 CFR Part 11. We’re partnered with a multi-site data center that has ISO 27001 certification along with a backup policy that performs hourly transaction log backups, daily differential backups and a bi-weekly full backup. You can also view the status of your backups at any given time.
Grand Avenue ensures regulatory compliance by providing tools for document control, Complaint Handling, CAPA management (SCARs), Supplier Management, Nonconforming Material Reports, Training Management (assessments are available within the module), and Audit readiness. The software aligns with standards like ISO 13485 and 21 CFR Part 11, offering features such as electronic signatures, audit trails, and out-of-the-box compliant workflows.
Migrating your existing QMS documents and processes into Grand Avenue Software is a streamlined process involving several key steps. First, assess and clean up your existing data to determine what will be transferred. Next, update your QMS procedures to align to Grand Avenue’s module workflows. Then, use the platform’s bulk upload feature to import documents and configure workflows to automate your operations. Finally, validate the system to ensure compliance, and provide training for your team to ensure a smooth transition, or ask Grand Avenue about their full service implementation option.
Yes, Grand Avenue Software can be used by internationally based medical device companies or those intending to sell devices in international markets. The platform supports compliance with global regulatory standards, including ISO 13485 and the EU Medical Device Regulation (MDR), as well as FDA 21 CFR Part 11 for U.S. markets. Its flexible, modular design allows it to adapt to different regulatory requirements across various regions, making it ideal for companies operating globally. Additionally, its cloud-based architecture allows easy access from any location, supporting international operations.
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 timeframe includes steps such as:
1. Initial setup and configuration
2. Data migration
3. Process customization
4. Employee training
5. Testing and validation
Grand Avenue’s support team works closely with your organization to ensure a smooth transition and successful implementation. However, the timeline can be adjusted based on your company’s specific requirements and readiness.
Grand Avenue Software is primarily a cloud-based SaaS platform, offered via a subscription model based on the features and number of users you need. It’s hosted on secure cloud servers, and all maintenance and updates are managed by Grand Avenue.
Grand Avenue Software offers onboarding services that include setup, data migration, training, and customization. Reach out to us to discuss your needs, time-frame and our cost-effect solutions.
Need More Information?
Grand Avenue is here to help! Contact us with any questions.