Grand Avenue Software was purpose-built for medical device and life science companies — it is not a generic quality management tool adapted for the industry. The platform delivers out-of-the-box compliance with ISO 13485:2016, FDA 21 CFR Part 820, EU MDR 2017/745, and 21 CFR Part 11, with built-in workflows, electronic signatures, and audit trails aligned…
Yes. Grand Avenue Software provides real-time process metrics through custom dashboards that give live visibility into quality system performance. Teams can monitor CAPA status, complaint trends, training completion, audit findings, and supplier performance across all modules from a single interface. Built-in charts and reporting tools allow quality leaders to identify trends, prioritize actions, and prepare…
Yes. Grand Avenue Software’s modular eQMS provides traceability across the full product lifecycle — from design inputs and Design and Development Files in the Design Control module, through risk controls in Risk Management, to post-market activities including complaints, CAPAs, nonconformances, and supplier quality. All modules are integrated within the same platform, so quality events and…
Yes. Grand Avenue Software’s eQMS includes dedicated modules for CAPA, Complaint Handling, and Nonconforming Materials — all integrated within the same platform. These modules share data and workflows, so a complaint can trigger a CAPA, a nonconformance can be linked to corrective actions, and all related records are maintained in one auditable system. This connected…
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.
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 Software’s support team works closely…
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…
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 Software.
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 Software’s module workflows. Then, use the platform’s bulk upload feature to import…
Grand Avenue Software 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…
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…