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Average Ratings 0 Ratings

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ease
features
design
support

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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

The Intact Platform, a cloud-based and on-premise Enterprise Resource Planning solution (ERP), is the best for audits, assessments certification, accreditation, and other standards. It is more than any other audit collection tool on the market. It offers a complete solution that helps you manage communications and business goals as well as personnel. Intact Platform is unrivaled in functionality and features an end-to-end modular workflow that is easily scaleable. 34% efficiency increase on average (upto 60+%) Unmatched modularity, flexibility and scalability All standards and audit services Digital workflow - no need for paper Remote and on-site auditing Non-conformities and corrective actions Planning and risk-based auditing Communication with clients is easy Reporting and business intelligence (BI). Management and central data hub (incl. Audit trail complete Innovation never stops

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Azure Storage
ComponentOne
Conholdate.Total For .NET
Conholdate.Total for Java
GitHub
Google Maps
Highcharts
Microsoft 365
Pimberly
SQLite

Integrations

Azure Storage
ComponentOne
Conholdate.Total For .NET
Conholdate.Total for Java
GitHub
Google Maps
Highcharts
Microsoft 365
Pimberly
SQLite

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

On request
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Grand Avenue Software

Founded

2002

Country

United States

Website

www.grandavenue.com

Vendor Details

Company Name

Intact

Founded

2001

Country

Austria

Website

intact-systems.com

Product Features

Calibration Management

Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Change Management

Approval Workflow
Audit Trail
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Release Management
Task Management
Tracking & Reporting
Training Management

Complaint Management

Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Self Service Portal
Social Media Monitoring
Survey Management

Document Version Control

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

Preventive Maintenance

Condition Monitoring
Inspection Management
Maintenance Scheduling
Mobile Access
Predictive Maintenance
Purchasing
Reminders
To-Do List
Vendor Management
Work Order Management

Quality Management

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

Vendor Management

Audit Management
Contact Management
Customer Database
Self Service Portal
Supplier Master Data
Transaction History
Vendor Maintained Profiles
Vendor Managed Inventory
Vendor Performance Rating
Vendor Qualification Tracking

Product Features

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Food Traceability

CRM
Order Management
Product Lifecycle Management
Production Management
Quality Control
Recall Management
Recipe Management
Traceability
Traceback & Traceforward

Quality Management

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

Supply Chain Management

Demand Planning
Electronic Data Interchange
Import / Export Management
Inventory Management
Order Fulfillment
Order Management
Sales & Operations Planning
Shipping Management
Supplier Management
Transportation Management
Warehouse Management

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