Audience
Researchers and companies seeking a quality management system solution
About FMEA Database
Build a simple and efficient Quality Management System (QMS). Install on your local server or leverage our Cloud QMS solution. Implement risk based thinking required by ISO 9001:2015. Risk Assessment: Failure Modes and Effects Analysis (FMEA). Implement risk based strategies for ISO 9001:2015, ISO 14971. Identify failure modes for each process or item. Identify effects and severity. Identify causes and frequency. Identify current controls and detection levels. Develop multiple actions associated with this failure mode. Assign owners and due dates. Establish verification and validation criteria. Electronic signature for management approval. User login: define user passwords and privileges. Rich set of reports. Track open actions and delinquent due dates. Free runtime version of Access is available from Microsoft. Export data to Excel for further analysis. Common, convenient software platform.
Dot Compliance QMS
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements.
Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE!
Processes included:
▶ Document Management
▶ Training Management
▶ Quality Event Management
▶ CAPA Management
▶ Change Management
▶ Complaint Management
▶ Audit Management
▶ Supplier Quality Management
▶ Risk Management
▶ Design Control
▶ Deviations/Non-conformances
✔ Seamless Install
✔ Cost Effective
✔ One-Stop-Shop
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6clicks
6clicks is an easy way to implement your risk and compliance program or achieve compliance with ISO 27001, SOC 2, PCI-DSS, HIPAA, NIST, FedRamp and many other standards.
Hundreds of businesses trust 6clicks to set up and automate their risk and compliance programs and streamline audit, vendor risk assessment, incident and risk management and policy implementation. Easily import standards, laws, regulations or templates from our massive content library, use AI-powered features to automate manual tasks, and integrate 6clicks with over 3,000 apps you know and love.
6clicks has been built for businesses of all shapes and sizes and is also used by advisors with a world-class partner program and white label capability available.
6clicks was founded in 2019 and has offices in the United States, United Kingdom, India and Australia.
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Total Lean Management (TLM) Software
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals.
TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types.
Core modules include:
• Audits
• Contact Manager (CRM)
• CAPA
• Customer Feedback
• Document Management
• Electronic Forms
• Employees
• Employee Feedback
• Equipment Calibration
• Evaluations
• FMEA
• Inspections
• Inventory/parts
• Library
• Meetings/Reviews
• Metrics
• Projects
• Purchase Orders
• Quality Record Mgt
• Rejected Materials
• Risk & Opportunities
• Sales Orders
• Strategic Planning
• Surveys
• Tasks/Events
• Training
• Work Orders
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DataLyzer FMEA
For manufacturers worldwide, FMEA has become critical in avoiding risk and minimizing quality cost. DataLyzer FMEA links DFMEA, Process Flow, PFMEA, Control Plan. From Control Plan the SPC setup can be automatically created.
Many features are available like reference or Foundation FMEAs, different criteria or classification sets, full authorization, Document and issuing control, Action management, Ballooning import, Automatic translation, Reporting, ITAR configuration etc etc
DataLyzer® FMEA is one of the modules in the DataLyzer software suite. The program closely follows the methodology defined in VDA AIAG and RM13004. DataLyzer FMEA can operate as a stand-alone module or link to DataLyzer SPC software.
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Pricing
Starting Price:
$135.00/one-time
Pricing Details:
Multiple user licenses are available. Licensing based on concurrent users.
Free Version:
Free Version available.
Free Trial:
Free Trial available.
Integrations
No integrations listed.
Company Information
Sunday Business Systems
Founded: 2004
United States
sundaybizsys.com/fmea-database/
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Product Details
Platforms Supported
SaaS
Windows
On-Premises
Training
Documentation
Live Online
Webinars
Support
Phone Support
FMEA Database Frequently Asked Questions
FMEA Database Product Features
Risk Management
Compliance Management
Corrective Actions (CAPA)
Internal Controls Management
Legal Risk Management
Operational Risk Management
Reputation Risk Management
Response Management
Risk Assessment
Alerts/Notifications
Auditing
Business Process Control
Dashboard
Exceptions Management
IT Risk Management
Mobile Access
Predictive Analytics