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
Knowllence acts as a risk management integrator, providing software, training, and consulting services that ensure effective quality, safety, and environmental (QSE) risk management. Safeguard your employees by managing safety through comprehensive documentation, arduousness assessments, and chemical risk evaluations. Enhance your design process with robust methodologies like functional analyses, Failure Modes and Effects Analysis (FMEA), and Fault Tree Analysis (FTA). Ensure the reliability of your industrialization phase by utilizing tools such as AMDEC Process FMEA and establishing a meticulous monitoring plan. Align your risk control measures with ISO 14971 standards for the design and safety of your medical devices. Our team is adept at understanding your specific methodologies and can tailor the configuration of our software to align seamlessly with your existing standards and processes. We offer a comprehensive service designed to streamline your work sessions and risk assessments, empowering you to advance your projects while maintaining a sustainable system: you retain control over the study and the action plans within an efficient, user-friendly software environment. By partnering with us, you can enhance your organization's ability to manage risks effectively and ensure compliance with industry requirements.
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
Yes
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
Yes
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
Knowllence
Founded
1997
Country
France
Website
www.knowllence.com/en/
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
Risk Management
Alerts/Notifications
No
Auditing
No
Business Process Control
No
Compliance Management
No
Corrective Actions (CAPA)
No
Dashboard
No
Exceptions Management
No
IT Risk Management
No
Internal Controls Management
No
Legal Risk Management
No
Mobile Access
No
Operational Risk Management
No
Predictive Analytics
No
Reputation Risk Management
No
Response Management
No
Risk Assessment
No