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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 8D Manager?

Personalized labels make data entry in 8D Manager an effortless experience. Once you enter data, the system promptly saves it, guaranteeing that your reports remain current at all times. To enhance efficiency, you can easily duplicate an existing corrective action report for new entries. The software also includes user-friendly drop-down menus that speed up the data input process, and if you have data in a spreadsheet, it can be smoothly imported into the system. Moreover, your corrective action procedures can integrate external documents, such as customer complaints, failure analyses, and images. With 8D Manager, you are able to create hyperlinks to all pertinent supporting documents within each report, ensuring that all necessary files are accessible in one centralized location. For any sensitive actions that you wish to keep confidential from printed, PDF, or email formats, you have the option to hide individual actions. This feature allows you to maintain an exhaustive record for internal reviews while managing the visibility of details in your final reports. Additionally, this capability ensures that your team can conduct comprehensive evaluations without jeopardizing the confidentiality of certain actions, fostering a secure and efficient review process. Overall, 8D Manager empowers users with the tools needed for effective data management and reporting.

Media

Media

Integrations Supported

Integrations Supported

Microsoft Access

API Availability

Has API

API Availability

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

$89 per month

Supported Platforms

SaaS

Supported Platforms

Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Not specified

Company Facts

Organization Name

Grand Avenue Software

Date Founded

2002

Company Location

United States

Company Website

www.grandavenue.com

Company Facts

Organization Name

8D Manager

Company Website

www.quality-assurance-solutions.com/8D-Manager.html

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

Root Cause Analysis

Not specified

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