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What is Grand Avenue Software?

An online software solution tailored for medical device manufacturers that streamlines their operations and eases adherence to regulatory standards. This suite features modules such as Audit Management, Corrective and Preventive Actions (CAPA), and Complaint Handling. It has been specifically developed to ensure compliance with ISO 13485 and 21 CFR Part 11 from the outset, providing a robust framework for quality management. Additionally, its user-friendly interface allows companies to efficiently navigate complex compliance requirements while maintaining high standards of product safety and effectiveness.

What is Audit Manager?

The Audit Manager software streamlines the quality management process by enabling digital monitoring of audits, quality controls, and assessments through every phase, from planning and checklist development to evidence gathering, field assessments, and handling nonconformities. Users can conveniently utilize the integrated calendar feature to schedule audits while including vital information like the subject matter, checklist, lead auditor, co-auditor, and participant details. The system allows both internal and external team members to receive prompt email notifications and access the audit timetable directly within the application. Once the inspection concludes, users can swiftly create audit reports in either PDF or Excel formats, making it easy to share them with company leadership or relevant stakeholders via mobile devices. Additionally, all meeting minutes are systematically archived for easy retrieval, ensuring they can be effectively incorporated into the organization’s document management systems. This efficient approach not only saves valuable time but also fosters improved communication and collaboration among all involved parties, ultimately leading to a more accountable audit process. Moreover, the software's user-friendly interface enhances the overall experience, making it accessible for all users regardless of their technical expertise.

Media

Media

Integrations Supported

Integrations Supported

Microsoft Excel

API Availability

Has API

API Availability

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS
On-Prem

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Documentation Hub
Online Training
On-Site Training

Company Facts

Organization Name

Grand Avenue Software

Date Founded

2002

Company Location

United States

Company Website

www.grandavenue.com

Company Facts

Organization Name

Focus Informatica

Company Location

Italy

Company Website

www.focus-auditmanager.com/software-audit-ispezioni-controlli

Categories and Features

Calibration Management

Calibration Instructions
Calibration Schedules
Due Date Tracking

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Training Management

Change Management

Approval Workflow
Audit Trail
Release Management
Task Management
Training Management

Complaint Management

Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Issue Tracking
Quality Assurance Management
Routing

Document Version Control

Access Controls/Permissions
Approval Process Control
Audit Trail
Revision History

Equipment Management

Not specified

Preventive Maintenance

Maintenance Scheduling
Reminders

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Vendor Management

Audit Management
Vendor Qualification Tracking

Categories and Features

Audit

Not specified

CAPA

Not specified

Compliance

Not specified

EHS Management

Not specified

Inspection

Not specified

Quality Management

Not specified

Safety Management

Not specified

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