Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
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