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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

Ideagen Supplier Management covers the supplier quality lifecycle: qualification and onboarding, performance monitoring and scorecarding, non-conformance management, corrective action tracking, supply chain risk assessment, supplier audits and supplier communication. Capabilities: - Supplier qualification: AI-guided workflows standardize every assessment and accelerate onboarding, with a complete audit trail - Performance scorecards: automated scorecarding tracks quality metrics, identifies trends and gives every supplier a standardized evaluation - Non-conformance and corrective action: automated CAPA workflows for root cause analysis, resolution tracking and effectiveness monitoring - Supply chain risk management: AI assesses performance data, market conditions and compliance status for early warnings and mitigation strategies - Supplier communication: one place for supplier interactions, with automated notifications that keep improvement projects on track AI analyzes supplier history, industry data and regulatory requirements to surface risks, and drafts root cause analyses and corrective action reports. Your team reviews and approves every report. Connects with ERP systems and document management platforms. Shares data with CAPA management, document control, audit management, regulatory intelligence and quality control in the Ideagen quality platform.

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 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 Yes 
iPad App Yes 
Android App Yes 
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 Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Grand Avenue Software

Founded

2002

Country

United States

Website

www.grandavenue.com

Vendor Details

Company Name

Ideagen

Founded

1993

Country

United Kingdom

Website

www.ideagen.com/solutions/quality/supplier-quality-management

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

Complaint Management

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

Food Traceability

CRM No 
Order Management No 
Product Lifecycle Management No 
Production Management No 
Quality Control No 
Recall Management No 
Recipe Management No 
Traceability No 
Traceback & Traceforward No 

Product Lifecycle Management

Change Management No 
Compliance Management No 
Cost Tracking No 
Design Management No 
Document Management No 
Product Data Management No 
Project Management No 
Requirements Management No 
Supplier Management No 

Quality Management

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

Supply Chain Management

Demand Planning No 
Electronic Data Interchange No 
Import / Export Management No 
Inventory Management No 
Order Fulfillment Yes 
Order Management No 
Sales & Operations Planning No 
Shipping Management No 
Supplier Management No 
Transportation Management No 
Warehouse Management No 

Vendor Management

Audit Management No 
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 No 

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