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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.

What is BPAQuality365?

BPAQuality365 is a quality management system (QMS) software that operates within the secure environment of Microsoft 365 cloud. It utilizes familiar tools that your team already engages with daily, eliminating the need for any alterations to user habits. This modern software is versatile, functioning seamlessly across all devices while being tailored to meet your specific requirements, and it harnesses the latest M365 technologies. The application boasts robust features for managing compliance documents, conducting audits, tracking non-conformances, implementing CAPA actions, and handling processes, process maps, incidents, changes, risks, FMEA, SWOT analyses, equipment, and health, safety, and environmental modules in adherence to ISO 9001, FDA Part 11, and medical regulations. Furthermore, the QMS application integrates smoothly with Teams, allowing users to inquire about the QMS during discussions and easily share QMS cards with colleagues. You can elevate your endeavors toward Quality 4.0 by leveraging advanced AI capabilities alongside superior workflow automation and insightful business intelligence. BPA's status as a Microsoft Preferred partner enables you to tailor your QMS according to your unique demands, collaborate effectively with power users, and deepen your understanding of M365 technologies, ultimately enhancing your organization's overall efficiency and compliance.

Media

Media

Integrations Supported

Integrations Supported

Microsoft 365

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

BPA propose per user/reader pricing conditions for small to large organizations.
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Grand Avenue Software

Date Founded

2002

Company Location

United States

Company Website

www.grandavenue.com

Company Facts

Organization Name

BPA Solutions

Date Founded

2001

Company Location

US/Switzerland

Company Website

www.bpa-solutions.net/software/office365-quality-app/

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

Categories and Features

AI Automation

Not specified

CAPA

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

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
Environmental Compliance
FDA Compliance
ISO Compliance
Incident Management
Risk Management
Surveys & Feedback
Version Control
Workflow / Process Automation

ISO Compliance

Not specified

Life Sciences

Not specified

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

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