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Description

A web-based software suite for medical device companies that automates their processes and simplifies regulatory compliance. Modules include Audit Management, CAPA and Complaint Handling. Designed from the start for ISO 13485 compliance and 21 CFR Part 11 compliance.

Description

QualSmart is an innovative cloud-based Quality Management Software (QMS) that empowers organizations to digitize, standardize, and oversee their quality and compliance procedures through customizable solutions that meet specific business requirements. This versatile platform features specialized tools for various functions including document management, audit management, corrective and preventive actions (CAPA), supplier quality management, training management, laboratory information management (LIMS), environmental monitoring, regulatory management, specification management, digital records, recall management, and visitor management. Targeted at industries such as Food & Beverage, FMCG, Manufacturing, Packaging, Chemicals, Cosmetics, Hospitality, and Retail, QualSmart facilitates the transition from manual quality processes to organized digital workflows, with automated approvals, customizable forms, notifications, dashboards, and comprehensive reporting capabilities. By leveraging these advanced features, organizations can enhance the consistency of their processes and ensure the integrity of their quality records while streamlining overall operational efficiency. Ultimately, QualSmart positions teams to achieve higher standards of quality and compliance in a rapidly evolving marketplace.

API Access

Has API Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

No images available

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

Quote based
Free Trial Yes 
Free Version 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 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App Yes 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours No 
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 No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Grand Avenue Software

Founded

2002

Country

United States

Website

www.grandavenue.com

Vendor Details

Company Name

QualSmart.ai

Founded

2018

Country

Canada

Website

qualsmart.ai/

Product Features

Calibration Management

Calibration Instructions Yes 
Calibration Schedules Yes 
Compliance Management No 
Device History No 
Due Date Tracking Yes 
Gage Management No 
Label Printing No 
Measurement Readings No 
Multi-Station Management No 
Out-of-Tolerance Notification No 
Statistical Data Reporting No 

CAPA

Audit Management Yes 
CAPA Planning Yes 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management No 
Root Cause Analysis No 
Training Management Yes 

Change Management

Approval Workflow Yes 
Audit Trail Yes 
Automated Notifications No 
Change Calendar No 
Change Planning No 
Compliance Management No 
Prioritization No 
Release Management Yes 
Task Management Yes 
Tracking & Reporting No 
Training Management Yes 

Complaint Management

Case Management No 
Complaint Classification Yes 
Corrective Actions (CAPA) Yes 
Customer Complaint Tracking Yes 
Feedback Management No 
Forms Management No 
Issue Tracking Yes 
Quality Assurance Management Yes 
Routing Yes 
Self Service Portal No 
Social Media Monitoring No 
Survey Management No 

Document Version Control

Access Controls/Permissions Yes 
Approval Process Control Yes 
Archiving & Retention No 
Audit Trail Yes 
Commenting / Notes No 
Document Check-in / Check-out No 
For Engineering Documents No 
Revision History Yes 
Version Comparison No 
Version Rollback No 

Preventive Maintenance

Condition Monitoring No 
Inspection Management No 
Maintenance Scheduling Yes 
Mobile Access No 
Predictive Maintenance No 
Purchasing No 
Reminders Yes 
To-Do List No 
Vendor Management No 
Work Order Management No 

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 No 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Vendor Management

Audit Management Yes 
Contact Management No 
Customer Database No 
Self Service Portal No 
Supplier Master Data No 
Transaction History No 
Vendor Maintained Profiles No 
Vendor Managed Inventory No 
Vendor Performance Rating No 
Vendor Qualification Tracking Yes 

Product Features

Quality Management

Audit Management No 
Complaint Management No 
Compliance Management No 
Corrective and Preventive Actions (CAPA) No 
Defect Tracking No 
Document Control No 
Equipment Management No 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
Supplier Quality Control No 
Training Management No 

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