Average Ratings 858 Ratings
Average Ratings 1 Rating
Description
Qualio is a purpose-built quality and compliance platform for life sciences companies operating in complex, high-stakes regulatory environments. Medical device, SaMD, biotech, and pharma teams use Qualio to replace fragmented eQMS tools, spreadsheets, and consultant-driven audits with a single, validated system that delivers continuous audit and inspection readiness.
Qualio combines a modern eQMS with Compliance Intelligence—an AI-driven layer that continuously evaluates how well real operating data aligns with regulatory requirements. Instead of treating audits as one-off events, teams gain always-on visibility into compliance coverage, risk exposure, and readiness across FDA, ISO, EU MDR, GxP, and software-intensive standards.
Core quality workflows—document control, training, CAPA, change management, supplier quality, and design controls—are directly connected to regulatory obligations and objective evidence. Deep integrations with Jira, Azure DevOps, GitHub, TestRail, and Salesforce automatically capture proof from development and operational systems, eliminating manual evidence gathering and reducing compliance drag on engineering teams.
Compliance Intelligence runs multi-standard gap analysis in under an hour, flags emerging risks before they become findings or 483s, and maps reusable evidence across frameworks to accelerate submissions and market expansion. All insights are explainable and traceable back to specific clauses and internal policies, supporting validation and audit expectations.
The result: audit readiness in weeks instead of months, fewer fire drills, faster launches, and lower long-term compliance cost. Qualio turns compliance from a reactive burden into a predictable, scalable system.
Description
SCIIL eLPA is a specialized software for managing Layered Process Audits, tailored for shopfloor environments in industrial production, which enhances the frequency of audits and boosts operational efficiency.
By transitioning from traditional paper methods to a structured and fully traceable digital solution, it facilitates seamless execution of layered process audits. Key features include mobile audit capabilities, automated planning, management of findings, and comprehensive LPA dashboards that empower quality teams to oversee the entire auditing process while maintaining uniform standards.
The software's robust digital LPA dashboard allows for quick identification of deviations, enabling teams to implement immediate corrective actions. With a role-based access system and a well-organized framework, SCIIL eLPA is adept at meeting the complexities of modern manufacturing settings.
Unlike generic auditing tools, SCIIL eLPA is specifically crafted for the manufacturing sector and shopfloor applications, making it an excellent choice for organizations aiming to digitize their layered process audits, enhance overall performance, and ensure consistency across various locations. Additionally, its user-friendly interface and comprehensive features make it a valuable asset for businesses seeking to optimize their auditing processes.
API Access
Has API
API Access
Has API
Integrations
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure-AD-External-Identities
ComplianceWire
Dynamics 365 Customer Service
GitHub Advanced Security
Google Cloud Operations Suite
HubSpot CRM
Integrations
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure-AD-External-Identities
ComplianceWire
Dynamics 365 Customer Service
GitHub Advanced Security
Google Cloud Operations Suite
HubSpot CRM
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
$25/month/user
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
Qualio
Founded
2010
Country
United States
Website
www.qualio.com
Vendor Details
Company Name
SCIIL AG
Founded
2002
Country
Germany
Website
www.sciil.com
Product Features
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Policy Management
Approval Process Control
Attestation
Audit Trails
Policy Creation
Policy Library
Policy Metadata Management
Policy Training
Reporting / Analytics
Version Control
Workflow Management
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