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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
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Medical Device, Quality Management, QMS, Product Development, Quality, Regulatory

Audience

Life science companies

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

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
Free Trial

Pricing

$25,000 / 1st year
25k for first year with a 5 license minimum
Free Version
Free Trial

Reviews/Ratings

Overall 4.3 / 5
ease 4.4 / 5
features 4.4 / 5
design 4.3 / 5
support 4.3 / 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

  • 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
  • Easy UI. Great theme; professional. Very well structured. Easy to navigate. Great reminder feature.
  • Very helpful, easy to use, valuable experience, and definitely worth the investment. Helpful, useful, easy to use, and worth the investment.
  • Greenlight Guru takes a lot of the manual stress out of maintaining a DHF and QMS, and it makes audits noticeably easier to prepare for and get through. The structure it enforces around documentation is genuinely useful, especially compared to more ad hoc systems.

Cons

  • 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.
  • Would love an AI summary feature to quickly summarize long documents when feasible
  • No major issues found so far; overall experience has been positive and satisfying.No major issues experienced so far.
  • As someone who joined a company with an already well-established QMS in Greenlight Guru, I found the sheer volume of files a bit daunting to navigate at first. The system relies heavily on filters and groupings that someone else has already set up, so if you don't already know what you're looking for, it can be hard to find your way around. A more traditional tiered/folder-style view would have made it much easier to explore and orient myself, especially as a newer user.

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
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

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
CAQ.Net

CAQ.Net

CAQ AG Factory Systems
Greenlight Guru Clinical

Greenlight Guru Clinical

Greenlight Guru
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences

Categories

Categories

Quality Management Features

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

Quality Management Features

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

CAPA Features

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

Change Management Features

Approval Workflow
Audit Trail
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Release Management
Task Management
Tracking & Reporting
Training Management

Complaint Management Features

Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Self Service Portal
Social Media Monitoring
Survey Management

Compliance Features

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control Features

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

Document Management Features

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

Document Version Control Features

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

Risk Management Features

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
Internal Controls Management
IT Risk Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

SPC Features

Corrective Actions (CAPA)
Data Entry
Data Linking
Data Management
Excel Loader
Job Management
OPC Data Collection
Performance Metrics
Point-of-Production Analysis
Real Time Data Collection
Regulatory Compliance

Work Instructions Features

Branding & Style Sheets
Content Management System
Drag and Drop
Dynamic Tags
Employee Feedback
Guide Approval Workflows
Media Editor
Multi-Brand Publishing
Rich Text Editor
SSO (SAML)
Translations
User Management
Version Control

Integrations

GitHub
Google Drive
Inspired eLearning HR & Compliance
Jira
Microsoft 365
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
Res_Q
SAP Business ByDesign
Showpad Coach
VIPRE Security Awareness

Integrations

GitHub
Google Drive
Inspired eLearning HR & Compliance
Jira
Microsoft 365
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
Res_Q
SAP Business ByDesign
Showpad Coach
VIPRE Security Awareness
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