LICENSALE

LICENSALE

Arazy Group
+
+

Related Products

  • Qualio
    919 Ratings
    Visit Website
  • Propel
    212 Ratings
    Visit Website
  • isoTracker Quality Management
    19 Ratings
    Visit Website
  • AlisQI
    108 Ratings
    Visit Website
  • MRPeasy
    252 Ratings
    Visit Website
  • Resource Guru
    1,043 Ratings
    Visit Website
  • Lockbox LIMS
    72 Ratings
    Visit Website
  • Retreat Guru
    134 Ratings
    Visit Website
  • Epicor Connected Process Control
    4 Ratings
    Visit Website
  • Intelex
    180 Ratings
    Visit Website

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

All-in-one global regulatory affairs system, complete with registration management software and worldwide assistance from regulatory experts. The registration system you need to initiate, renew, amend or transfer your medical device or IVD market access approval. LICENSALE®‘s intuitive user interface with real-time data includes complete project management, infographic analytics, an effective collaboration platform, future market access planning and advanced reporting. It puts you in control of your global medtech registration activities. Arazy Group “in-country” regulatory experts review your compliance documents, assisting in the preparation and submission of your applications. They work with authorities until you obtain your desired marketing approvals. LICENSALE® includes submission and compliance requirements specific for your product in over 140 countries as well as regulatory experts to assist with each of these markets.

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

Healthcare providers interested in a global regulatory affairs system to manage their regulatory requirements

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

No information available.
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 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

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.

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

Arazy Group
Canada
arazygroup.com/licensale-2/

Alternatives

Alternatives

Propel

Propel

Propel Software
Regislate

Regislate

Arazy Group
Jama Connect

Jama Connect

Jama Software
Greenlight Guru Clinical

Greenlight Guru Clinical

Greenlight Guru
Rimsys

Rimsys

Rimsys Regulatory Management Software

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

Integrations

GitHub
Google Drive
Jira
Microsoft 365

Integrations

GitHub
Google Drive
Jira
Microsoft 365
Claim Greenlight Guru and update features and information
Claim Greenlight Guru and update features and information
Claim LICENSALE and update features and information
Claim LICENSALE and update features and information