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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 Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

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 Not Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

Free
Free Version Supported
Free Trial Not Supported

Pricing

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 Version Not Supported
Free Trial Not Supported

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 Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported

Company Information

OpenSourcePV
Founded: 2019
United States
www.opensourcepv.com

Company Information

Qualio
Founded: 2010
United States
www.qualio.com

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QT9 QMS

QT9 QMS

QT9 Software

Categories

Pharmacovigilance Supported

Categories

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Supported
Incident Management Supported
ISO Compliance Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Supported

Policy Management Features

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

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Integrations

Asana Not Supported
Auth0 Not Supported
Azure AI Anomaly Detector Not Supported
Azure DevOps Server Not Supported
Azure-AD-External-Identities Not Supported
ComplianceWire Not Supported
Dynamics 365 Customer Service Not Supported
GitHub Not Supported
GitLab Not Supported
Google Cloud Operations Suite Not Supported
Intercom Not Supported
Jira Not Supported
Microsoft 365 Not Supported
Microsoft Dynamics 365 Not Supported
Okta Not Supported
RegDesk Not Supported
Salesforce Not Supported
TestRail Not Supported
Xray Not Supported
Zendesk Not Supported

Integrations

Asana Supported
Auth0 Supported
Azure AI Anomaly Detector Supported
Azure DevOps Server Supported
Azure-AD-External-Identities Supported
ComplianceWire Supported
Dynamics 365 Customer Service Supported
GitHub Supported
GitLab Supported
Google Cloud Operations Suite Supported
Intercom Supported
Jira Supported
Microsoft 365 Supported
Microsoft Dynamics 365 Supported
Okta Supported
RegDesk Supported
Salesforce Supported
TestRail Supported
Xray Supported
Zendesk Supported
Claim OpenSourcePV and update features and information
Claim OpenSourcePV and update features and information