Related Products
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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.
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About
Batch records, cleaning, environmental monitoring & inventory management. Optimize advanced therapy production with software designed for GMP. It’s one more way to align your workforce for ‘right-first-time manufacturing’. Get rid of fragmented paperwork
with one software that everyone can use for data collection, review & approval workflows, reporting, and analytics. Ensure your team follows the
correct steps in due time to enable the right manufacturing with interactive work instructions. 21 CFR part 11 and EU Vol 4 annex 11 compliant for your peace of mind. Make logging information intuitive with bar code scanning, built-in data integrity checks, and automated calculations. Highlighting out of specs and review by approval comes built-in. Know where your samples are in the testing process. Organize sample plans and automate trending. Know where your samples are in the testing process. Manage tasks to keep cleanrooms clean and track any production process.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Medical Device, Quality Management, QMS, Product Development, Quality, Regulatory
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Audience
Biopharmaceutical companies seeking a tool to improve the digitalization of their regulated laboratory and cleanroom workflows
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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PricingModules:
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
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Pros & Cons from Real UsersPros
Cons
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationGreenlight Guru
Founded: 2013
United States
greenlight.guru
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Company InformationMyCellHub
Founded: 2019
Belgium
www.mycellhub.com
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Categories |
Categories |
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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
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Integrations
GitHub
Google Drive
Jira
Microsoft 365
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