Easy, Modular & Built for Growth
Grand Avenue Software is a flexible suite of out-of-the-box quality management and compliance solutions for medical products companies.
Assured Compliance
Rapid Deployment
Low Cost of Ownership
Advanced Technology
Grand Avenue’s web-based solution leverages state-of-the-art user interface and data center advancements to provide a reliable, always available, and secure solution that fits within your budget.
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.
Enterprise Integrations
Authentication Management
Grand Avenue’s Authentication Management provides support for single sign-on (SSO) authentication within Grand Avenue.
“Our experience working with the Grand Avenue Software (GAS) team has been absolutely wonderful! Their out of the box solution and ease in configuring our needs has been the highlight of our experience. GAS has enabled us to exponentially reduce our time spent in the manual processes for controlled documents and training management.”
Dhruti S.
Induce Biologics
Compliance Functionality
Grand Avenue’s out-of-the-box features, forms, and workflows incorporate proven best practices to deliver needed functionality for compliance.
Compliance Functionality
Grand Avenue’s out-of-the-box features, forms, and workflows incorporate proven best practices to deliver needed functionality for compliance.
Service and Support
Grand Avenue’s best-in-class software support combined with an extensive implementation partner network ensures your deployment success.
Service and Support
Grand Avenue’s best-in-class software support combined with an extensive implementation partner network ensures your deployment success.
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.