eQMS

Grand Avenue Software eQMS is a cloud-based, modular quality management system designed for medical products companies, including medical device manufacturers operating in domestic and international markets. The platform provides out-of-the-box workflows, forms, and compliance features aligned with ISO 13485:2016, 21 CFR Part 820, EU MDR 2017/745, and 21 CFR Part 11, and is offered as a SaaS subscription with licensing based on features and number of users.

The system is structured around a suite of independent modules covering design and development, document and training management, and core quality system functions. Its web-based architecture allows access from any location, and onboarding typically takes four to eight weeks depending on organizational complexity and the modules being implemented.

Technology and Platform Capabilities

• Cloud-native deployment with built-in security, encryption, access control, and audit trails; hosted at an ISO 27001-certified multi-site data center with hourly transaction log backups, daily differential backups, and bi-weekly full backups.
• Built-in compliance alignment with ISO 13485:2016, 21 CFR Part 820, and EU MDR 2017/745.
• 21 CFR Part 11 support for electronic signatures and electronic records.
• Process-driven workflows with automated task routing and deadline alerts to support team accountability.
• Included validation packets to support computer software assurance (CSA) efforts, with optional full validation services available.
• Custom dashboards providing real-time visibility into quality system performance metrics.
• Standards-based API connector for integration with other information systems.
• Single sign-on (SSO) authentication support via the Authentication Management module.

Design and Development Modules

• Design Control: Manages and tracks design projects through lifecycle phases and maintains the electronic Design History File (DHF).
• Risk Management: Supports identification of hazards and harms associated with medical devices, and facilitates estimation, evaluation, mitigation, and control of associated risks.
• Requirements Management: Handles submission, routing, review, approval, and implementation of electronic document changes and deviations.

Document and Training Management Modules

• Document Control: Supports submission, routing, approval, and implementation of electronic document changes and deviations.
• Training Management: Defines and manages training requirements, authorizes users for read-and-understand training, certifies training requirements, and measures training effectiveness.
• Training Assessment: Extends the Training Management module to include tests and quizzes for assessing user understanding of completed training.

Quality System Modules

• Audit Management: Manages internal, supplier, and external audits, and records findings, observations, and resolutions.
• CAPA: Manages corrective actions, preventive actions, and supplier corrective action requests (SCARs), including root-cause analysis, action plans, and verification of results.
• Complaint Handling: Captures, tracks, and manages product and service issues, supporting prioritization, investigation, reporting, and trending of complaints.
• Nonconforming Materials: Supports identification, quarantine, disposition, tracking, and trending of product nonconformances.
• Equipment Management: Manages equipment calibration, maintenance, qualification activities, and unplanned events.
• Supplier Management: Supports supplier review and approval, management of the Approved Supplier List (ASL), and definition, management, and scheduling of supplier controls.

Data Migration and Onboarding Process

1. Assess and clean up existing data to determine what will be transferred.
2. Update QMS procedures to align with Grand Avenue's module workflows.
3. Use the platform's bulk upload feature to import documents and configure workflows.
4. Validate the system to confirm compliance.
5. Provide team training to support a smooth transition.

Grand Avenue Software is delivered exclusively as a cloud-hosted SaaS platform; it is not available for on-premises server installation. The company offers onboarding services covering setup, data migration, training, and customization, and maintains an implementation partner network to support deployment. The platform is suitable for internationally based companies or those selling into international markets, given its support for global regulatory standards including ISO 13485 and EU MDR.