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What is ISO Office?

Evaluate compliance by monitoring actions such as Non-Conformance Reports, incidents, near misses, and management review actions, since effective Non-Conformance Management plays a vital role in promoting continuous improvement. With ACTION Manager, your business operations can be transformed by consolidating and managing all documentation within one centralized platform, enabling seamless integration across a unified system, a single organization, and various locations and countries. DOC Manager supports your company’s objectives by applying the SMART framework, which guarantees that your goals are Specific, Measurable, Achievable, Relevant, and Time-Bound. Utilizing Objective Manager allows you to proficiently manage your employees' training requirements, offering a clear method for tracking and maintaining training records along with competency assessments. Training Manager provides you with the tools to oversee your internal audit life cycle, improving audit effectiveness throughout your organization. The Management of Change application streamlines your change management procedures, guiding you through every stage from initiation and assessment to execution and follow-up, thus ensuring a systematic approach to changes within the organization. By incorporating these innovative tools, your organization can enhance compliance and boost operational efficiency across every department. Ultimately, this comprehensive approach fosters a culture of accountability and continuous improvement that benefits the entire organization.

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

ISO Software

Company Location

South Africa

Company Website

www.iso-office.co.za

Company Facts

Organization Name

Grand Avenue Software

Date Founded

2002

Company Location

United States

Company Website

www.grandavenue.com

Categories and Features

Project Management

Not specified

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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