Average Ratings 13 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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

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 
Microsoft Teams No 
SAP ERP No 
Teamcenter 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 
Microsoft Teams Yes 
SAP ERP Yes 
Teamcenter 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.
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 

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