FMEA Database

FMEA Database

Sunday Business Systems
FMEA Database Qualtrax

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FMEA Database:

About

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.
Qualtrax:

About

Qualtrax is a complete quality and compliance software system used to manage and control documentation, automate key business processes with customizable workflows, streamline training management, manage internal and external audits and ensure critical industry regulations are addressed in real-time. Qualtrax is an invaluable resource in heavily-regulated industries, where complying with standards including ISO 17025, 17020, 13485, and 9001, TNI, GFSI, FDA, and FQS is required.
FMEA Database:

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported
Qualtrax:

Platforms Supported

Windows Supported
Mac Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported
FMEA Database:

Audience

Researchers and companies seeking a quality management system solution
Qualtrax:

Audience

Quality and Compliance professionals
FMEA Database:

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Not Supported
Qualtrax:

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported
FMEA Database:

API

Offers API Not Supported
Qualtrax:

API

Offers API Not Supported
FMEA Database:

Screenshots and Videos

Qualtrax:

Screenshots and Videos

FMEA Database:

Pricing

$135.00/one-time
Multiple user licenses are available. Licensing based on concurrent users.
Free Version Supported
Free Trial Supported
Qualtrax:

Pricing

Pricing is determined on a per-user basis, with multiple license types available. Please contact us for a quote regarding your specific situation.
Free Version Not Supported
Free Trial Supported
FMEA Database:

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software
Qualtrax:

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software
FMEA Database:

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported
Qualtrax:

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported
FMEA Database:

Company Information

Sunday Business Systems
Founded: 2004
United States
sundaybizsys.com/fmea-database/
Qualtrax:

Company Information

Qualtrax
Founded: 1993
United States
www.qualtrax.com
FMEA Database:

Alternatives

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DataLyzer FMEA

DataLyzer International
4.8 out of 5 stars
Qualtrax:

Alternatives

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SurveyJS

4.8 out of 5 stars
FMEA Database:
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SBS Quality Database

Sunday Business Systems
5.0 out of 5 stars
Qualtrax:
FMEA Database:
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Flokzu

5.0 out of 5 stars
FMEA Database:
Qualtrax:
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Intellect

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FMEA Database:
SoftExpert FMEA

SoftExpert FMEA

SoftExpert
Qualtrax:
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
FMEA Database:

Categories

FMEA Supported
ISO Compliance Supported
Risk Management Supported
Qualtrax:

Categories

Audit Supported
Compliance Supported
Document Control Supported
ISO Compliance Supported
Quality Management Supported
FMEA Database:

Risk Management Features

Alerts/Notifications Not Supported
Auditing Not Supported
Business Process Control Not Supported
Compliance Management Supported
Corrective Actions (CAPA) Supported
Dashboard Not Supported
Exceptions Management Not Supported
Internal Controls Management Supported
IT Risk Management Not Supported
Legal Risk Management Supported
Mobile Access Not Supported
Operational Risk Management Supported
Predictive Analytics Not Supported
Reputation Risk Management Supported
Response Management Supported
Risk Assessment Supported
Qualtrax:

Accreditation Management Features

Collaboration Supported
Compliance Management Supported
Document Management Supported
Higher Education Supported
Requirements Management Supported
Reviewer Portal Not Supported
Self Assessment Supported
User Access Permissions Supported
Workflow Management Supported

Audit Features

Alerts / Notifications Supported
Audit Planning Supported
Compliance Management Supported
Dashboard Supported
Exceptions Management Not Supported
Forms Management Not Supported
Issue Management Supported
Mobile Access Supported
Multi-Year Planning Not Supported
Risk Assessment Supported
Workflow Management Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Not Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Not Supported
Incident Management Supported
ISO Compliance Supported
OSHA Compliance Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Supported

Document Control Features

Archiving & Retention Supported
Automated Routing Supported
Change Management Supported
Compliance Management Supported
Electronic Signature Supported
Escalation Management Supported
Periodic Review Supported
Version Control Supported

Document Management Features

Access Controls Supported
Archiving & Retention Supported
Collaboration Tools Supported
Compliance Tracking Supported
Document Archiving Supported
Document Assembly Supported
Document Capture Not Supported
Document Conversion Supported
Document Delivery Supported
Document Indexing Supported
Document Retention Supported
Electronic Signature Supported
Email Management Supported
File Recovery Supported
File Type Conversion Supported
Forms Management Supported
Full Text Search Supported
Offline Access Supported
Optical Character Recognition Supported
Print Management Supported
Version Control Supported

Document Version Control Features

Access Controls/Permissions Supported
Approval Process Control Supported
Archiving & Retention Supported
Audit Trail Supported
Commenting / Notes Supported
Document Check-in / Check-out Supported
For Engineering Documents Supported
Revision History Supported
Version Comparison Supported
Version Rollback Supported

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported
FMEA Database:

Integrations

Microsoft 365 Supported
Azure SQL Database Supported
Brandwatch Not Supported
Sunday Business Systems Supported
Qualtrax:

Integrations

Microsoft 365 Supported
Azure SQL Database Not Supported
Brandwatch Supported
Sunday Business Systems Not Supported
FMEA Database:
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Qualtrax:
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