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About

Trusted by over 1,000 medical device manufacturers, Greenlight Guru is a quality management system built for the medtech industry. The platform is architected around regulatory reality, not generic enterprise frameworks. FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 11 are aligned at the foundation, not added later. Implementation takes weeks, not quarters. With 80+ audit-tested templates and medtech-expert support, you skip the separate validation project and go live faster. Greenlight Guru integrates AI-powered automation to reduce manual work while maintaining the audit trail and documentation rigor your business requires. With 15 years in medical device QMS, Greenlight Guru helps you pass inspections, accelerate time-to-market, and sustain commercial success.

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, Quality Management, QMS, Product Development, Quality, Regulatory

Audience

Life science companies

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

Modules:
Document Management
Change Management
Training Management
Supplier Management
Design Controls
Risk Management
Parts Management
Quality Events
Software Parts
Software Release Management
SBOM Management
Software Test Automations

Pricing is custom scoped.
Free Version Not Supported
Free Trial Not 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 4.4 / 5
ease 4.5 / 5
features 4.5 / 5
design 4.4 / 5
support 4.4 / 5

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

  • What I like most about Greenlight Guru is how organized and user-friendly the platform is. It makes it much easier to manage documentation, keep track of processes, and maintain everything in one place. The workflow is straightforward, and having everything centralized saves a lot of time compared to managing things manually.
  • Easy-to-use interface for managing quality and compliance documentation. Strong traceability between requirements, risks, tests, and design controls. Centralized document management improves team collaboration and audit preparedness. Helpful customer support and onboarding experience. Saves time by streamlining regulatory and quality management processes.
  • Easy to search, easy to navigate, like that is accessed via web. The pricepoint is competitive compared to other platforms. It is ISO 13485 compliant
  • Greenlight Guru provides a well-organized platform for managing quality processes and documentation. The interface is straightforward, and having quality-related information in one centralized location makes collaboration and document management much easier.
  • Easy UI. Great theme; professional. Very well structured. Easy to navigate. Great reminder feature.

Cons

  • The platform can take some time to get used to when you first start using it, especially with all of the features and options available. Some areas could also be a little more intuitive, but once you become familiar with the system, it is fairly easy to navigate.
  • Some areas of the platform can occasionally feel slow when working with large datasets. Reporting and workflow customization options could be more flexible. Initial setup and configuration may require time for new users.
  • CO process is very complicated, the uploading process and the "checking out" of the documents is very complicated. there is no collaboration workflow. It requires word documents for some aspects of the CO, but PDFs for other. Very hard to get it right without the intervention of documents control. Should include an option to allow user to see redlines from the documents page, rather than having to download the CO packet.
  • Some workflows can take time to learn, especially for new users. Certain areas of the interface could also be more intuitive, and additional flexibility or customization would make everyday tasks easier.
  • Would love an AI summary feature to quickly summarize long documents when feasible

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

Greenlight Guru
Founded: 2013
United States
greenlight.guru

Company Information

MasterControl
Founded: 1994
United States
www.mastercontrol.com

Alternatives

Alternatives

Propel

Propel

Propel Software
Propel

Propel

Propel Software
Jama Connect

Jama Connect

Jama Software
Greenlight Guru Clinical

Greenlight Guru Clinical

Greenlight Guru
CAQ.Net

CAQ.Net

CAQ AG Factory Systems

Categories

Categories

Quality Management Features

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

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

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

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

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

GitHub Supported
Google Drive Supported
Inspired eLearning HR & Compliance Not Supported
Jira Supported
Microsoft 365 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

GitHub Not Supported
Google Drive Not Supported
Inspired eLearning HR & Compliance Supported
Jira Not Supported
Microsoft 365 Not 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 Greenlight Guru and update features and information
Claim Greenlight Guru and update features and information
Claim MasterControl and update features and information
Claim MasterControl and update features and information