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What is iPassport?

iPassport serves as a sophisticated software solution specifically designed for healthcare laboratories, with the goal of improving digitization, organization, and the management of quality and compliance on a daily basis. This platform includes a wide range of quality management modules that facilitate the oversight of various elements, from document control to employee training processes. All managed documents are centralized for convenience, equipped with specific access and editing rights, and feature complete revision histories for accountability. It contains all the essential tools required for effectively handling both internal and external audits. Users can document and track non-conformities, corrective measures, and incidents, while also overseeing staff training, competencies, tasks, meetings, and leave schedules. Furthermore, it boasts a comprehensive supplier database and auditing tool that features performance assessments. The system is adept at managing and monitoring assets and inventory, ensuring that detailed maintenance records for all equipment are maintained. By utilizing iPassport, healthcare laboratories can enhance their operational efficiency, uphold regulatory compliance, and facilitate a culture of continuous improvement. This ultimately enables laboratories to deliver higher quality care and improve patient outcomes.

What is Grand Avenue Software?

An online software solution tailored for medical device manufacturers that streamlines their operations and eases adherence to regulatory standards. This suite features modules such as Audit Management, Corrective and Preventive Actions (CAPA), and Complaint Handling. It has been specifically developed to ensure compliance with ISO 13485 and 21 CFR Part 11 from the outset, providing a robust framework for quality management. Additionally, its user-friendly interface allows companies to efficiently navigate complex compliance requirements while maintaining high standards of product safety and effectiveness.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Genial Genetic Solutions

Company Location

United Kingdom

Company Website

www.genialcompliance.com/products/ipassport/

Company Facts

Organization Name

Grand Avenue Software

Date Founded

2002

Company Location

United States

Company Website

www.grandavenue.com

Categories and Features

Medical Lab

Audit Trail
Data Analysis Auditing
Data Security
EMR Interface
Fax Management
Lab Instrument Interface
Multi-Location Printing
Online Instrumentation
Physician Test Panels
Procedure-Based Billing
Sample Tracking

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

Categories and 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

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