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

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

SoftTech Health provides an extensive array of quality management software solutions specifically designed for the healthcare sector today. By offering seamless integration, you can efficiently consolidate all your quality management activities into one user-friendly software platform. Our Accreditation Manager is designed to assist you in preparing for upcoming inspections, equipped with features that allow you to easily compare and transfer data from prior inspections. It automatically monitors compliance evidence, ensuring that crucial details are not overlooked. Each inspection requires careful attention to detail to guarantee that all requirements are met; it also aims to minimize the time spent on coordination, tracking, and reporting during audits, while simplifying the often tedious process of collecting supporting documentation. The Accreditation Manager not only streamlines these essential tasks but also enhances compliance and positively impacts your financial outcomes, demonstrating its value across multiple facets of healthcare management. Additionally, this software empowers organizations by providing insights that can lead to continuous improvement in quality management practices.

API Access

Has API Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
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 No 
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 Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs No 
Webinars Yes 
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

SoftTech Health

Founded

2003

Country

United States

Website

softtechhealth.com/products/

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

Accreditation Management

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

CAPA

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

Document Management

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

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 

Alternatives

SBS Quality Management Software Reviews

SBS Quality Management Software

Sunday Business Systems

Alternatives

Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences