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Average Ratings 858 Ratings

Description

Stay informed about the latest regulations regarding substances and efficiently address customer inquiries by utilizing BOMcheck tools to create Regulatory Compliance Declarations (RCD) and Full Materials Declarations (FMD). The centralized blockchain database significantly reduces both time and costs for suppliers striving to remain compliant with global substance regulations. Suppliers can securely manage their information within the database and easily download declarations in various industry-standard formats, including IPC 1752A XML, IPC 1752B XML, PDF, or Excel. Establishing a Manufacturer Account is free, provided your company is willing to participate in a pilot program with a select group of suppliers; upon successful completion of the pilot to your satisfaction, you can then invite your suppliers to join BOMcheck at your discretion. This streamlined process not only fosters compliance but also enhances collaboration among suppliers in the industry.

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

Asana
Azure AI Anomaly Detector
Azure DevOps
Azure DevOps Labs
Azure-AD-External-Identities
ComplianceWire
Dynamics 365 Customer Service
Essenvia
GitHub
GitHub Advanced Security
GitHub Desktop
GitLab
GitLab Duo
Google Cloud Operations Suite
HubSpot CRM
Intercom
Microsoft 365
Microsoft OneDrive
Okta
Xray

Integrations

Asana
Azure AI Anomaly Detector
Azure DevOps
Azure DevOps Labs
Azure-AD-External-Identities
ComplianceWire
Dynamics 365 Customer Service
Essenvia
GitHub
GitHub Advanced Security
GitHub Desktop
GitLab
GitLab Duo
Google Cloud Operations Suite
HubSpot CRM
Intercom
Microsoft 365
Microsoft OneDrive
Okta
Xray

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

BOMcheck

Website

www.bomcheck.net/en

Vendor Details

Company Name

Qualio

Founded

2010

Country

United States

Website

www.qualio.com

Product Features

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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