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About

OpenSourcePV is a company founded by Lionel Van Holle in 2019 with the ambition to make use of free & open source technologies to raise the standards of pharmacovigilance and provide an affordable & competitive alternative to expensive software specialized in pharmacovigilance. To meet their regulatory obligations, pharma companies need to monitor the safety of their products. When they start to have a strong pipeline and multiple products on the market, the amount of data to be reviewed is soon too large to be reviewed manually. To benefit from quantitative analysis, they currently have two options: either they use an expensive suite of tools or they try to build something on their own. With OpenSourcePV, we accompany their journey in quantitative signal detection allowing them to benefit from pre-built modules and building something customized to their specific needs and data sources.

About

Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health. With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems. What Qualio delivers: ✔️ Audit ready in weeks ✔️ Inspection ready anytime — no fire drills ✔️ Faster market entry ✔️ Lower total cost of compliance ✔️ Confident, risk-managed scaling

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Healthcare and pharmaceutical enterprises in search of a solution to monitor product safety and perform quantitative signal detection

Audience

Small and growing businesses in Life Sciences & Healthcare

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

Free
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

OpenSourcePV
Founded: 2019
United States
www.opensourcepv.com

Company Information

Qualio
Founded: 2010
United States
www.qualio.com

Alternatives

Alternatives

Propel

Propel

Propel Software
Fusion eClinical Suite

Fusion eClinical Suite

Axiom Real-Time Metrics
isoTracker Quality Management

isoTracker Quality Management

isoTracker Solutions Ltd
PvEdge

PvEdge

Sarjen Systems
QT9 QMS

QT9 QMS

QT9 Software

Categories

Categories

Compliance Features

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Policy Management Features

Approval Process Control
Attestation
Audit Trails
Policy Creation
Policy Library
Policy Metadata Management
Policy Training
Reporting / Analytics
Version Control
Workflow Management

Quality Management Features

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

Integrations

Asana
Auth0
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure-AD-External-Identities
ComplianceWire
Essenvia
GitHub
HubSpot CRM
Jira
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
Okta
RegDesk
Salesforce
TestRail
Zephyr

Integrations

Asana
Auth0
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure-AD-External-Identities
ComplianceWire
Essenvia
GitHub
HubSpot CRM
Jira
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
Okta
RegDesk
Salesforce
TestRail
Zephyr
Claim OpenSourcePV and update features and information
Claim OpenSourcePV and update features and information