Average Ratings 12 Ratings
Average Ratings 2 Ratings
Description
Over 1,000 medical device manufacturers rely on Greenlight Guru, a quality management system purpose-built for medtech. The platform is designed around the regulatory environment your industry operates in, 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 configured later.
Implementation takes weeks, not quarters. With 80+ audit-tested templates and medtech-expert support, you avoid the lengthy validation project and launch faster.
Greenlight Guru uses AI-powered automation to eliminate manual administrative work while preserving the audit trail and documentation standards your compliance requires.
With 15 years in medical device quality systems, Greenlight Guru helps you pass audits, get to market faster, and sustain long-term success.
Description
SCIIL eLPA digitizes the complete Layered Process Audit process in manufacturing—from maintaining audit catalogs and scheduling audits to mobile execution, corrective actions and cross-plant reporting. Audit plans for operational layers can be generated automatically using frequencies, calendars, areas, shifts and auditor availability. Invitations, reminders and escalation messages help keep recurring LPAs and open actions on schedule. Auditors work on smartphones, tablets or PCs and can continue offline in production areas with unstable network coverage. They record OK/NOK answers, findings, descriptions and photos while consulting current work instructions and reference documents. Central audit standards can be distributed across multiple plants while allowing local sub-questions and translations. Findings and actions remain linked to their audits, with structured 4D and optional 8D processing, due dates and effectiveness checks. Dashboards, scheduled reports and Power BI integration give plant and corporate quality teams real-time visibility. Active Directory integration and role-based administration support enterprise deployment.
API Access
Has API
API Access
Has API
Integrations
Microsoft 365
Active Directory
GitHub
Google Drive
Jira
Microsoft Entra ID
Microsoft Outlook
Microsoft Power Automate
Microsoft Power BI
Microsoft SharePoint
Integrations
Microsoft 365
Active Directory
GitHub
Google Drive
Jira
Microsoft Entra ID
Microsoft Outlook
Microsoft Power Automate
Microsoft Power BI
Microsoft SharePoint
Pricing Details
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.
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 Trial
Free Version
Pricing Details
Contact us for pricing
Pricing is based on the number of manufacturing locations and the required system configuration. Standard and project-specific integrations are available. Please contact SCIIL for an individual quotation.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Greenlight Guru
Founded
2013
Country
United States
Website
greenlight.guru
Vendor Details
Company Name
SCIIL AG
Founded
2002
Country
Germany
Website
sciil.com/en/portfolio/layered-process-audits-software/
Product Features
Quality Management
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
Product Features
Quality Management
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