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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 AutoSHEQ?

Revamp your outdated, cumbersome management approach into a modern, efficient digital platform that saves costs. The Documentation module allows you to manage the review, editing, approval, distribution, and accessibility of all your documents with ease. It also provides the capability to monitor and address issues related to defects in your organization's products, services, or systems efficiently. You can organize how your data is reported by categorizing problems according to specific criteria like regions, services, product types, processes, and associated risks. In addition, the software supports the creation of schedules for both internal and supplier audits, ensuring that responsibilities are clearly defined and findings are linked to the respective planned audits. You can also set up a continuous schedule for calibration and maintenance tasks based on your desired frequency. All task records, along with pertinent attachments, are securely archived within the software. Notably, this module is provided at no extra charge, boosting your operational efficiency without impacting your financial resources. By adopting such a digital solution, you position your organization to thrive in an increasingly competitive landscape.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

$255 per month

Supported Platforms

SaaS

Supported Platforms

SaaS

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

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

AutoSHEQ Solutions

Date Founded

1997

Company Location

South Africa

Company Website

www.autosheq.com

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

Quality Management

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

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