aligned elements

aligned elements

Aligned AG
+
+

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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

Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity. The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle. Aligned products, designed for collaboration between quality, regulatory, R&D, and management teams, combines a complete electronic Quality Management System with deep Design Control functionality in one fully integrated environment. Design inputs, outputs, verification, validation, risk management, and change control are natively connected to the QMS, ensuring end to end traceability that stands up to audits and inspections.

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 Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

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

Audience

Medical Device Manufacturers looking for a design control management solution

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not 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

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Version Not Supported
Free Trial 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 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

  • 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

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Company Information

Greenlight Guru
Founded: 2013
United States
greenlight.guru

Company Information

Aligned AG
Founded: 2007
Switzerland
www.aligned.ch/

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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

Application Lifecycle Management Features

Administrator Level Control Supported
Defect Tracking Supported
Iteration Planning Not Supported
Project Management Not Supported
Release Management Supported
Requirements Review Supported
Task Management Supported
Test Case Tracking Supported
User Level Management Supported
Version Control Supported

Requirements Management Features

Automated Functional Sizing Not Supported
Automated Requirements QA Supported
Automated Test Generation Supported
Automated Use Case Modeling Not Supported
Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Supported
Traceability Supported
User Defined Attributes Supported

Integrations

GitHub Supported
Apache Subversion Not Supported
Azure DevOps Server Not Supported
GitLab Not Supported
Google Drive Supported
Jira Supported
Jira Align Not Supported
Microsoft 365 Supported
Redmine Not Supported

Integrations

GitHub Supported
Apache Subversion Supported
Azure DevOps Server Supported
GitLab Supported
Google Drive Not Supported
Jira Not Supported
Jira Align Supported
Microsoft 365 Not Supported
Redmine Supported
Claim Greenlight Guru and update features and information
Claim Greenlight Guru and update features and information
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Claim aligned elements and update features and information