Average Ratings 0 Ratings
Average Ratings 919 Ratings
Description
Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance solution includes an extensive set of off-the-shelf ready eQMS and compliance pre-configured processes, enabling customers to deploy quickly and cost effectively. Dot Compliance ready to use solutions include full project validation services and product validation packages. Dot Compliance offers the industry’s most cost-effective quality and compliance management solution available, allowing users to quickly deploy flexible and scalable solutions. Automate core quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, Supplier Quality, and more. Our solution is fully configurable and offers seamless integration abilities, with easy adaptation and implementation of customer’s specific requirements.
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.
API Access
Has API
Yes
API Access
Has API
No
Integrations
Salesforce
Yes
Auth0
No
Azure AI Anomaly Detector
No
Azure AI Document Intelligence
No
Azure DevOps Labs
No
Azure-AD-External-Identities
No
ComplianceWire
No
Dynamics 365 Customer Service
No
GitHub
No
GitHub Advanced Security
No
Integrations
Salesforce
Yes
Auth0
Yes
Azure AI Anomaly Detector
Yes
Azure AI Document Intelligence
Yes
Azure DevOps Labs
Yes
Azure-AD-External-Identities
Yes
ComplianceWire
Yes
Dynamics 365 Customer Service
Yes
GitHub
Yes
GitHub Advanced Security
Yes
Pricing Details
$10,000 / Annually
Starting at just 10,000$ a year
(validation included)
(validation included)
Free Trial
Yes
Free Version
No
Pricing Details
Qualio offers transparent, subscription-based pricing that scales with your users and needs. No hidden fees or per-module charges. Growth-stage companies benefit from fast time-to-value and significantly lower total cost of ownership than legacy platforms or consultant-heavy implementations. Contact us for a custom quote.n.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
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
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
No
Vendor Details
Company Name
QMS for Life Sciences
Founded
2007
Country
United States
Website
www.dotcompliance.com
Vendor Details
Company Name
Qualio
Founded
2010
Country
United States
Website
www.qualio.com
Product Features
Audit
Alerts / Notifications
Yes
Audit Planning
Yes
Compliance Management
Yes
Dashboard
Yes
Exceptions Management
Yes
Forms Management
Yes
Issue Management
Yes
Mobile Access
Yes
Multi-Year Planning
Yes
Risk Assessment
Yes
Workflow Management
Yes
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
Yes
Training Management
Yes
Change Management
Approval Workflow
Yes
Audit Trail
Yes
Automated Notifications
No
Change Calendar
Yes
Change Planning
No
Compliance Management
Yes
Prioritization
Yes
Release Management
Yes
Task Management
Yes
Tracking & Reporting
No
Training Management
Yes
Complaint Management
Case Management
Yes
Complaint Classification
Yes
Corrective Actions (CAPA)
Yes
Customer Complaint Tracking
Yes
Feedback Management
Yes
Forms Management
Yes
Issue Tracking
Yes
Quality Assurance Management
Yes
Routing
Yes
Self Service Portal
No
Social Media Monitoring
No
Survey Management
Yes
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
Yes
Environmental Compliance
No
FDA Compliance
Yes
HIPAA Compliance
No
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
Yes
Version Control
Yes
Workflow / Process Automation
Yes
Document Control
Archiving & Retention
Yes
Automated Routing
Yes
Change Management
Yes
Compliance Management
Yes
Electronic Signature
Yes
Escalation Management
Yes
Periodic Review
Yes
Version Control
Yes
Document Management
Access Controls
Yes
Archiving & Retention
Yes
Collaboration Tools
Yes
Compliance Tracking
Yes
Document Archiving
Yes
Document Assembly
Yes
Document Capture
Yes
Document Conversion
Yes
Document Delivery
Yes
Document Indexing
Yes
Document Retention
Yes
Electronic Signature
Yes
Email Management
No
File Recovery
Yes
File Type Conversion
Yes
Forms Management
Yes
Full Text Search
No
Offline Access
Yes
Optical Character Recognition
No
Print Management
Yes
Version Control
Yes
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
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Risk Management
Alerts/Notifications
Yes
Auditing
Yes
Business Process Control
Yes
Compliance Management
Yes
Corrective Actions (CAPA)
Yes
Dashboard
Yes
Exceptions Management
Yes
IT Risk Management
Yes
Internal Controls Management
Yes
Legal Risk Management
Yes
Mobile Access
Yes
Operational Risk Management
Yes
Predictive Analytics
Yes
Reputation Risk Management
Yes
Response Management
Yes
Risk Assessment
Yes
SPC
Corrective Actions (CAPA)
No
Data Entry
No
Data Linking
No
Data Management
No
Excel Loader
No
Job Management
No
OPC Data Collection
No
Performance Metrics
No
Point-of-Production Analysis
No
Real Time Data Collection
No
Regulatory Compliance
No
Product Features
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
Yes
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
Yes
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
Yes
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
Yes
Policy Management
Approval Process Control
Yes
Attestation
Yes
Audit Trails
Yes
Policy Creation
Yes
Policy Library
Yes
Policy Metadata Management
Yes
Policy Training
Yes
Reporting / Analytics
Yes
Version Control
Yes
Workflow Management
Yes
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
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes