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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

Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.

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 Supported
iPad Supported
Android Supported
Chromebook Not Supported

Audience

Medical Device Manufacturers that need an advanced Calibration Management solution

Audience

Life science companies

Support

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

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Not Supported
Free Trial Supported

Pricing

$25,000 / 1st year
25k for first year with a 5 license minimum
Free Version Not Supported
Free Trial Not Supported

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

Reviews/Ratings

Overall 4.5 / 5
ease 4.5 / 5
features 5.0 / 5
design 4.5 / 5
support 4.5 / 5

Pros & Cons from Real Users

Pros

  • Documents,training and quality all link up together. Has the ability to create custom web forms to meet the specific needs of the company. It enables business process workflow.
  • - The best feature is definitely the fact that this is a web based tool that stores everything in the cloud and has no system dependency.

Cons

  • Such function is good but simple searches can turn up too many unnecessary results.
  • The UI can definitely be further simplified to remove unnecessary buttons that might confuse the uninitiated. Currently, it's also a bit difficult to get help information from the UI.

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

MasterControl
Founded: 1994
United States
www.mastercontrol.com

Alternatives

Alternatives

SBS Quality Management Software

SBS Quality Management Software

Sunday Business Systems
Propel

Propel

Propel Software
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
CAQ.Net

CAQ.Net

CAQ AG Factory Systems

Categories

Categories

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

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

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

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

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

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 Supported
Root Cause Analysis Not Supported
Training Management Supported

Change Management Features

Approval Workflow Supported
Audit Trail Supported
Automated Notifications Not Supported
Change Calendar Not Supported
Change Planning Supported
Compliance Management 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 Supported
Forms Management 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 Supported
Audit Trail Supported
Commenting / Notes Supported
Document Check-in / Check-out Supported
For Engineering Documents Supported
Revision History Supported
Version Comparison Supported
Version Rollback 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

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Not Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Supported
Incident Management Not Supported
ISO Compliance Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Supported

Document Control Features

Archiving & Retention Supported
Automated Routing Supported
Change Management Supported
Compliance Management Supported
Electronic Signature Supported
Escalation Management Supported
Periodic Review Supported
Version Control Supported

Document Management Features

Access Controls Supported
Archiving & Retention Supported
Collaboration Tools Supported
Compliance Tracking Supported
Document Archiving Supported
Document Assembly Supported
Document Capture Not Supported
Document Conversion Supported
Document Delivery Supported
Document Indexing Supported
Document Retention Supported
Electronic Signature Supported
Email Management Supported
File Recovery Supported
File Type Conversion Supported
Forms Management Supported
Full Text Search Supported
Offline Access Supported
Optical Character Recognition Supported
Print Management Supported
Version Control Supported

Risk Management Features

Alerts/Notifications Supported
Auditing Supported
Business Process Control Supported
Compliance Management Supported
Corrective Actions (CAPA) Supported
Dashboard Supported
Exceptions Management Not Supported
Internal Controls Management Supported
IT Risk Management Not Supported
Legal Risk Management Not Supported
Mobile Access Supported
Operational Risk Management Supported
Predictive Analytics Supported
Reputation Risk Management Not Supported
Response Management Supported
Risk Assessment Supported

SPC Features

Corrective Actions (CAPA) Supported
Data Entry Not Supported
Data Linking Not Supported
Data Management Not Supported
Excel Loader Not Supported
Job Management Not Supported
OPC Data Collection Not Supported
Performance Metrics Not Supported
Point-of-Production Analysis Not Supported
Real Time Data Collection Not Supported
Regulatory Compliance Supported

Work Instructions Features

Branding & Style Sheets Not Supported
Content Management System Not Supported
Drag and Drop Not Supported
Dynamic Tags Not Supported
Employee Feedback Not Supported
Guide Approval Workflows Not Supported
Media Editor Not Supported
Multi-Brand Publishing Not Supported
Rich Text Editor Not Supported
SSO (SAML) Not Supported
Translations Not Supported
User Management Not Supported
Version Control Supported

Integrations

Inspired eLearning HR & Compliance Not Supported
Microsoft Excel Not Supported
Microsoft PowerPoint Not Supported
Microsoft Word Not Supported
Res_Q Not Supported
SAP Business ByDesign Not Supported
Showpad Coach Not Supported
VIPRE Security Awareness Not Supported

Integrations

Inspired eLearning HR & Compliance Supported
Microsoft Excel Supported
Microsoft PowerPoint Supported
Microsoft Word Supported
Res_Q Supported
SAP Business ByDesign Supported
Showpad Coach Supported
VIPRE Security Awareness Supported
Claim Grand Avenue Software and update features and information
Claim Grand Avenue Software and update features and information
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Claim MasterControl and update features and information