Average Ratings 12 Ratings

Total
ease
features
design
support

Average Ratings 2 Ratings

Total
ease
features
design
support

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

Screenshots View All

Screenshots View All

Integrations

Microsoft 365
Active Directory
GitHub
Google Drive
Jira
Microsoft Entra ID
Microsoft Outlook
Microsoft Power Automate
Microsoft Power BI
Microsoft SharePoint
Microsoft Teams
SAP ERP
Teamcenter

Integrations

Microsoft 365
Active Directory
GitHub
Google Drive
Jira
Microsoft Entra ID
Microsoft Outlook
Microsoft Power Automate
Microsoft Power BI
Microsoft SharePoint
Microsoft Teams
SAP ERP
Teamcenter

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.
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

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