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features
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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

Streamline the creation and modification of FMEA, Process Flow Diagrams, and Control Plans like never before. The FMEA methodology can be quite intricate, but with FMEA Studio's automated features, you can significantly reduce the likelihood of errors. It offers user-friendly functionalities that make sharing documents with others a breeze. FMEA Studio accommodates various risk indices, including RPN, SOD, and CN, along with their respective evaluation techniques. You have the capability to assess FMEA risks through both 2D and 3D risk matrices, enhancing your analysis. Ranking parameters such as Severity, Occurrence, or Detection levels is made simpler and quicker with intuitive ranking tables that can be tailored to your specific requirements. Additionally, FMEA Studio provides a structural tree for visualizing structure, function, and failure analyses. Accessing editing tools is straightforward through a convenient right-click menu, ensuring an efficient workflow throughout the entire process. With these features, FMEA Studio not only enhances productivity but also promotes collaboration among team members for improved outcomes.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Azure SQL Database Yes 
Microsoft 365 Yes 
Microsoft Excel No 
Sunday Business Systems Yes 

Integrations

Azure SQL Database No 
Microsoft 365 No 
Microsoft Excel Yes 
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

$89 per user per month
Free Trial Yes 
Free Version Yes 

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 No 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
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

FMEA Studio

Website

www.iqasystem.com/fmea-studio/

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

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