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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

Create a simple, efficient Quality Management System (QMS). You can install on your local server, or use our Cloud QMS solution. ISO 9001:2015 requires risk-based thinking. Risk Assessment: Failure Modes Analysis (FMEA) Implement risk-based strategies for ISO 9001, ISO 14971. Identify failure modes for each item or process. Identify the effects and severity. Identify the causes and frequency. Identify current controls and detection levels. Multiple actions should be taken in response to this failure mode. Assign owners and due dates. Establish verification and validation criteria. Management approval can be obtained by electronic signature. User login: Define passwords and privileges. Rich set of reports. Track open actions and delinquent due date. Microsoft Access is free to download. To further analyze the data, export it to Excel. Common, easy-to-use software platform

Description

The Failure Reporting, Analysis, and Corrective Action System (FRACAS) serves as a comprehensive feedback mechanism that facilitates collaboration between users and suppliers to gather, document, and evaluate failures related to both hardware and software systems. During the design evolution phase, corrective actions (CAR) are most effective, but as the design solidifies, implementing these actions becomes increasingly costly and constrained. The analysis conducted within this framework pinpoints necessary corrective measures that must be executed and verified to avert the recurrence of failures. By fostering reliability enhancements throughout the equipment's lifecycle, FRACAS can be applied during various testing phases, including in-house laboratory evaluations, field tests (whether alpha or beta), and production operations, enabling stakeholders to identify and address areas of concentrated issues within the equipment's design. This systematic approach not only enhances product reliability but also ensures a more efficient path to problem resolution.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Azure SQL Database Yes 
Microsoft 365 Yes 
Sunday Business Systems Yes 

Integrations

Azure SQL Database No 
Microsoft 365 No 
Sunday Business Systems No 

Pricing Details

$135.00/one-time
Multiple user licenses are available. Licensing based on concurrent users.
Free Trial Yes 
Free Version Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Sunday Business Systems

Founded

2004

Country

United States

Website

sundaybizsys.com/fmea-database/

Vendor Details

Company Name

Qsoft

Website

www.qsoft.cc/qsoft_website/FRACAS.aspx

Product Features

Risk Management

Alerts/Notifications No 
Auditing No 
Business Process Control No 
Compliance Management Yes 
Corrective Actions (CAPA) Yes 
Dashboard No 
Exceptions Management No 
IT Risk Management No 
Internal Controls Management Yes 
Legal Risk Management Yes 
Mobile Access No 
Operational Risk Management Yes 
Predictive Analytics No 
Reputation Risk Management Yes 
Response Management Yes 
Risk Assessment Yes 

Product Features

CAPA

Audit Management No 
CAPA Planning No 
Change Management No 
Complaint Management No 
Incident Management No 
Nonconformance Tracking No 
Quality Control No 
Risk Management No 
Root Cause Analysis No 
Training Management No 

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