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About

A web-based quality system software suite that helps medical device companies automate their processes and simplify regulatory compliance. Modules include: Audit Management, CAPA, Complaint Handling, Design Control, Document Control, Equipment Management, Nonconforming Materials Reporting, Supplier Management and Training Management. Designed from the beginning for ISO 13485 and 21 CFR Part 11 compliance. Audit results are recorded for each requirement in the audit. Requirements are marked as conforming, nonconforming, or not applicable. Each result may be detailed with one or more findings. Findings that may be recorded include observations, major nonconformances, and/or minor nonconformances. Findings may result in Corrective and Preventive Actions (CAPA) and/or may be documents with audit actions already completed.

About

Apollo Root Cause Analysis™ is a principle-based problem solving method designed to help you master problem-solving strategies. Combined with RC Pro® software, you can easily construct an evidence-based understanding of any problem. An evidence-based understanding of causes and effects leads to effective solutions that are accepted by your entire organization. The Apollo Root Cause AnalysisTM methodology facilitates the creation of a common reality using input from all stakeholders to produce an evidence-based understanding of the problem. This ensures your solutions address proven causes to prevent a recurrence. It makes problem-solving easy and gives those who have been trained, the skills to solve real-world problems more efficiently and effectively. RC Pro is a complete and adaptable root cause analysis software solution that can be fit to companies of any size and across any industry. RC Pro allows your organization to integrate its problem-solving capabilities.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Supported
Mac Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Medical Device Manufacturers that need an advanced Calibration Management solution

Audience

Companies searching for a solution to master problem solving strategies

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Not Supported
Free Trial Supported

Pricing

$295.00/one-time/user
Free Version Not Supported
Free Trial Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

Grand Avenue Software
Founded: 2002
United States
www.grandavenue.com

Company Information

RealityCharting
Founded: 1991
United States
www.realitycharting.com

Alternatives

Alternatives

Visplore

Visplore

Visplore GmbH
SBS Quality Management Software

SBS Quality Management Software

Sunday Business Systems
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
SolvoNext

SolvoNext

ORCA LEAN

Categories

Categories

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Supported
ISO Standards Management Not Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

CAPA Features

Audit Management Supported
CAPA Planning Supported
Change Management Supported
Complaint Management Supported
Incident Management Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Not Supported
Root Cause Analysis Not Supported
Training Management Supported

Calibration Management Features

Calibration Instructions Supported
Calibration Schedules Supported
Compliance Management Not Supported
Device History Not Supported
Due Date Tracking Supported
Gage Management Not Supported
Label Printing Not Supported
Measurement Readings Not Supported
Multi-Station Management Not Supported
Out-of-Tolerance Notification Not Supported
Statistical Data Reporting Not Supported

Change Management Features

Approval Workflow Supported
Audit Trail Supported
Automated Notifications Not Supported
Change Calendar Not Supported
Change Planning Not Supported
Compliance Management Not Supported
Prioritization Not Supported
Release Management Supported
Task Management Supported
Tracking & Reporting Not Supported
Training Management Supported

Complaint Management Features

Case Management Not Supported
Complaint Classification Supported
Corrective Actions (CAPA) Supported
Customer Complaint Tracking Supported
Feedback Management Not Supported
Forms Management Not Supported
Issue Tracking Supported
Quality Assurance Management Supported
Routing Supported
Self Service Portal Not Supported
Social Media Monitoring Not Supported
Survey Management Not Supported

Document Version Control Features

Access Controls/Permissions Supported
Approval Process Control Supported
Archiving & Retention Not Supported
Audit Trail Supported
Commenting / Notes Not Supported
Document Check-in / Check-out Not Supported
For Engineering Documents Not Supported
Revision History Supported
Version Comparison Not Supported
Version Rollback Not Supported

Preventive Maintenance Features

Condition Monitoring Not Supported
Inspection Management Not Supported
Maintenance Scheduling Supported
Mobile Access Not Supported
Predictive Maintenance Not Supported
Purchasing Not Supported
Reminders Supported
To-Do List Not Supported
Vendor Management Not Supported
Work Order Management Not Supported

Vendor Management Features

Audit Management Supported
Contact Management Not Supported
Customer Database Not Supported
Self Service Portal Not Supported
Supplier Master Data Not Supported
Transaction History Not Supported
Vendor Maintained Profiles Not Supported
Vendor Managed Inventory Not Supported
Vendor Performance Rating Not Supported
Vendor Qualification Tracking Supported

Quality Management Features

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

Integrations

No info available.

Integrations

No info available.
Claim Grand Avenue Software and update features and information
Claim Grand Avenue Software and update features and information
Claim RealityCharting and update features and information
Claim RealityCharting and update features and information