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
API Access
Has API
Integrations
Sunday Business Systems
Pricing Details
$135.00/one-time
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
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
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment
Product Features
Risk Management
Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment