Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

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

Qualtrax is a quality and compliance software program that can manage and control documentation, automate key business processes, streamline training management, manage external and internal audits, and ensure that critical industry regulations are met in real time. Qualtrax is a valuable resource in highly-regulated industries where compliance with standards such as ISO 17025 and 17020, 13485 and 9001, TNI and GFSI, FDA and FQS are required.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

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

Integrations

Microsoft 365 Yes 
Azure SQL Database No 
Brandwatch 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

Pricing is determined on a per-user basis, with multiple license types available. Please contact us for a quote regarding your specific situation.
Free Trial Yes 
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 Yes 
Mac Yes 
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) Yes 
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) Yes 
In Person Yes 

Vendor Details

Company Name

Sunday Business Systems

Founded

2004

Country

United States

Website

sundaybizsys.com/fmea-database/

Vendor Details

Company Name

Qualtrax

Founded

1993

Country

United States

Website

www.qualtrax.com

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

Accreditation Management

Collaboration Yes 
Compliance Management Yes 
Document Management Yes 
Higher Education Yes 
Requirements Management Yes 
Reviewer Portal No 
Self Assessment Yes 
User Access Permissions Yes 
Workflow Management Yes 

Audit

Alerts / Notifications Yes 
Audit Planning Yes 
Compliance Management Yes 
Dashboard Yes 
Exceptions Management No 
Forms Management No 
Issue Management Yes 
Mobile Access Yes 
Multi-Year Planning No 
Risk Assessment Yes 
Workflow Management Yes 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing No 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance No 
ISO Compliance Yes 
Incident Management Yes 
OSHA Compliance Yes 
Risk Management Yes 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control Yes 
Workflow / Process Automation Yes 

Document Control

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

Document Management

Access Controls Yes 
Archiving & Retention Yes 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture No 
Document Conversion Yes 
Document Delivery Yes 
Document Indexing Yes 
Document Retention Yes 
Electronic Signature Yes 
Email Management Yes 
File Recovery Yes 
File Type Conversion Yes 
Forms Management Yes 
Full Text Search Yes 
Offline Access Yes 
Optical Character Recognition Yes 
Print Management Yes 
Version Control Yes 

Document Version Control

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

Quality Management

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

Alternatives

SBS Quality Database Reviews

SBS Quality Database

Sunday Business Systems

Alternatives

DataLyzer FMEA Reviews

DataLyzer FMEA

DataLyzer International