Average Ratings 13 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
No
API Access
Has API
No
Integrations
Microsoft 365
Yes
Active Directory
No
GitHub
Yes
Google Drive
Yes
Jira
Yes
Microsoft Entra ID
No
Microsoft Outlook
No
Microsoft Power Automate
No
Microsoft Power BI
No
Microsoft SharePoint
No
Integrations
Microsoft 365
Yes
Active Directory
Yes
GitHub
No
Google Drive
No
Jira
No
Microsoft Entra ID
Yes
Microsoft Outlook
Yes
Microsoft Power Automate
Yes
Microsoft Power BI
Yes
Microsoft SharePoint
Yes
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
No
Free Version
No
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
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
Yes
iPad App
No
Android App
Yes
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
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
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Product Features
Quality Management
Audit Management
Yes
Complaint Management
No
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
No
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No