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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

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Not specified

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Webinars
Online 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

Not specified

Quality Management

Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Document Control
Equipment Management

Categories and Features

Calibration Management

Calibration Instructions
Calibration Schedules
Due Date Tracking

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Training Management

Change Management

Approval Workflow
Audit Trail
Release Management
Task Management
Training Management

Complaint Management

Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Issue Tracking
Quality Assurance Management
Routing

Document Version Control

Access Controls/Permissions
Approval Process Control
Audit Trail
Revision History

Equipment Management

Not specified

Preventive Maintenance

Maintenance Scheduling
Reminders

Quality Management

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

Vendor Management

Audit Management
Vendor Qualification Tracking

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