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Modular. Configurable. Scalable.
Grand Avenue Software provides the industry-leading quality management software solution for medical product companies. We are the affordable, scalable, and efficient eQMS deployed by med-tech innovators and leaders around the world. Our team has extensive experience in software development, Software as a Service (SaaS) delivery, and quality compliance, specifically for the life sciences industries.
We work hand-in-hand with startups, emerging growth and established companies to navigate the complex regulatory affairs (RA) and quality assurance (QA) environment. With Grand Avenue, compliance is assured, your budget is preserved.
Our Solution Suite
Audit Management
- Manage internal, supplier, and external audits.
- Record findings, observations, and resolutions.
- Link to CAPAs.
CAPA
- Manage corrective, preventive and continuous improvement requests.
- Track detailed root-cause analysis and action plans.
- Perform verification.
Complaint Handling
- Capture, track, and manage product or service issues.
- Prioritize, investigate, report, trend complaints.
Design Control
- Control-Submit, route, approve, and implement electronic document changes and deviations.
- Manage electronic documents.
Equipment Control
- Define, track and manage equipment, activities, and schedules.
- Manage calibration, maintenance and qualification activities, and unplanned (ad-hoc, repair) events.
Nonconforming Materials (NCM)
- Identify, quarantine, tag, disposition, track, and trend product nonconformances.
- Review/approve proposed dispositions via the NCM Review Board (MRB).
- Manage disposition implementation work.
Supplier Management
- Review and approve suppliers.
- Manage the Approved Supplier List (ASL).
- Define, manage, and schedule supplier controls.
- View summary of related CAPAs, audits, and nonconformances.
Training Assessment
- Extends the Training Management module to use tests/quizzes to assess a user’s competence, knowledge, and understanding while completing training.
- Define questions and answers within each assessment.
- Define the criteria for successful completion of the assessment (number of correct answers to pass).
- Define the situations where passing the assessment is required to complete the assigned 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.
- Automatically create training assignments for new document revision from Document Control.
Authentication Management
- Provides support for single sign-on (SSO) authentication within Grand Avenue.
- Supports enterprise authentication services such as Azure AD, Okta, and Google.
- Allows users to sign in using one set of credentials to multiple independent software systems including Grand Avenue.
- Provides a single point of control for IT departments to deactivate employees.
Connector
- Provides a rich, web-based Application Programming Interface (API) for facilitating communication between Grand Avenue and other important information systems.
- The Connector Read APls provide access to Grand Avenue information from external systems such as reporting tools and data warehouses.
- The Connector Write APls enable external systems to automate the creation of new information in a Grand Avenue instance.
Business Advantages
System Capabilities
The Grand Avenue solution suite meets your compliance needs, fits within your budget, and delivers clear and timely business value.
