Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Alternatives to Consider

  • SBS Quality Management Software Reviews & Ratings
    7 Ratings
    Company Website
  • AlisQI Reviews & Ratings
    108 Ratings
    Company Website
  • Certainty Software Reviews & Ratings
    93 Ratings
    Company Website
  • Intelex Reviews & Ratings
    180 Ratings
    Company Website
  • QA Wolf Reviews & Ratings
    270 Ratings
    Company Website
  • isoTracker Quality Management Reviews & Ratings
    19 Ratings
    Company Website
  • HSI Donesafe Reviews & Ratings
    176 Ratings
    Company Website
  • The Asset Guardian EAM (TAG) Reviews & Ratings
    22 Ratings
    Company Website
  • Revaly Reviews & Ratings
    7 Ratings
    Company Website
  • Checksum.ai Reviews & Ratings
    1 Rating
    Company Website

What is Qsoft FRACAS?

The Failure Reporting, Analysis, and Corrective Action System (FRACAS) functions as an all-encompassing feedback tool that encourages cooperation between users and suppliers to collect, record, and assess failures associated with both hardware and software systems. In the early stages of design evolution, implementing corrective actions (CAR) is most efficient; however, as the design becomes more established, these implementations tend to incur higher costs and face greater limitations. This analytical framework identifies essential corrective actions that need to be executed and validated to prevent future failures. By promoting reliability improvements throughout the equipment's entire lifecycle, FRACAS can be utilized during numerous testing stages, including in-house laboratory assessments, field trials (both alpha and beta), and production processes, allowing stakeholders to pinpoint and rectify recurring issues within the equipment's design. Ultimately, this structured methodology not only boosts product reliability but also leads to a more streamlined approach for resolving problems effectively. In addition, the continuous use of FRACAS fosters a culture of proactive risk management that can significantly enhance the overall quality of products.

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.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub
Webinars
Online Training

Company Facts

Organization Name

Qsoft

Company Website

www.qsoft.cc/qsoft_website/FRACAS.aspx

Company Facts

Organization Name

Grand Avenue Software

Date Founded

2002

Company Location

United States

Company Website

www.grandavenue.com

Categories and Features

CAPA

Not specified

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

Popular Alternatives

Relyence FRACAS Reviews & Ratings

Relyence FRACAS

Relyence Corporation

Popular Alternatives

SBS Quality Management Software Reviews & Ratings

SBS Quality Management Software

Sunday Business Systems
LINK Services Reviews & Ratings

LINK Services

Green Arrow Labs
Dot Compliance QMS Reviews & Ratings

Dot Compliance QMS

QMS for Life Sciences
ReliaSoft Reviews & Ratings

ReliaSoft

Hottinger Brüel & Kjær (HBK)