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Average Ratings 858 Ratings

Description

Cloud-first ERP solutions are specifically designed to meet the needs of life science companies. Merit for Life Science is a cloud-first ERP system that has been expertly crafted for manufacturers in the biotech, pharmaceutical, and medical device sectors. It enhances Dynamics 365 finance and operations, providing a seamless connection across your entire organization. This system effectively aligns resource qualifications with production needs, while also overseeing vendor relationships in procurement to ensure compliance with quality standards during manufacturing. By offering your life science organization enhanced visibility and transparency, it supports the delivery of safe and innovative products, among other benefits. Recognizing that each organization has its own distinct requirements, we are committed to understanding those needs. Explore the comprehensive solutions we provide, which are tailored to satisfy the stringent demands of the pharma, biotech, and medical device industries. Additionally, our system aids in refining your decision-making processes through dependable and auditable accounting practices, while also establishing robust financial reporting standards for acquired entities or preparing your organization for acquisition, ensuring you are always ready for the next step in your growth journey.

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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Microsoft Dynamics 365
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
GitHub Advanced Security
GitHub Desktop
GitLab
GitLab Duo
Google Cloud Operations Suite
HubSpot CRM
Intercom
Jira
Okta
RegDesk
TestRail
Zephyr

Integrations

Microsoft Dynamics 365
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
GitHub Advanced Security
GitHub Desktop
GitLab
GitLab Duo
Google Cloud Operations Suite
HubSpot CRM
Intercom
Jira
Okta
RegDesk
TestRail
Zephyr

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
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

Merit Solutions

Country

United States

Website

meritsolutions.com/merit-solutions-for-life-science/

Vendor Details

Company Name

Qualio

Founded

2010

Country

United States

Website

www.qualio.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

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