Average Ratings 0 Ratings
Average Ratings 2 Ratings
Description
A web-based software suite for medical device companies that automates their processes and simplifies regulatory compliance. Modules include Audit Management, CAPA and Complaint Handling. Designed from the start for ISO 13485 compliance and 21 CFR Part 11 compliance.
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
Yes
API Access
Has API
No
Integrations
Active Directory
No
Microsoft 365
No
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
Active Directory
Yes
Microsoft 365
Yes
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
No price information available.
Free Trial
Yes
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)
No
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
Grand Avenue Software
Founded
2002
Country
United States
Website
www.grandavenue.com
Vendor Details
Company Name
SCIIL AG
Founded
2002
Country
Germany
Website
sciil.com/en/portfolio/layered-process-audits-software/
Product Features
Calibration Management
Calibration Instructions
Yes
Calibration Schedules
Yes
Compliance Management
No
Device History
No
Due Date Tracking
Yes
Gage Management
No
Label Printing
No
Measurement Readings
No
Multi-Station Management
No
Out-of-Tolerance Notification
No
Statistical Data Reporting
No
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
No
Root Cause Analysis
No
Training Management
Yes
Change Management
Approval Workflow
Yes
Audit Trail
Yes
Automated Notifications
No
Change Calendar
No
Change Planning
No
Compliance Management
No
Prioritization
No
Release Management
Yes
Task Management
Yes
Tracking & Reporting
No
Training Management
Yes
Complaint Management
Case Management
No
Complaint Classification
Yes
Corrective Actions (CAPA)
Yes
Customer Complaint Tracking
Yes
Feedback Management
No
Forms Management
No
Issue Tracking
Yes
Quality Assurance Management
Yes
Routing
Yes
Self Service Portal
No
Social Media Monitoring
No
Survey Management
No
Document Version Control
Access Controls/Permissions
Yes
Approval Process Control
Yes
Archiving & Retention
No
Audit Trail
Yes
Commenting / Notes
No
Document Check-in / Check-out
No
For Engineering Documents
No
Revision History
Yes
Version Comparison
No
Version Rollback
No
Preventive Maintenance
Condition Monitoring
No
Inspection Management
No
Maintenance Scheduling
Yes
Mobile Access
No
Predictive Maintenance
No
Purchasing
No
Reminders
Yes
To-Do List
No
Vendor Management
No
Work Order Management
No
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Vendor Management
Audit Management
Yes
Contact Management
No
Customer Database
No
Self Service Portal
No
Supplier Master Data
No
Transaction History
No
Vendor Maintained Profiles
No
Vendor Managed Inventory
No
Vendor Performance Rating
No
Vendor Qualification Tracking
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