SmartISO

SmartISO

ODACITY LLC
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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

About

SmartISO is a cloud-based compliance and quality management platform for organizations managing ISO systems internally. It brings document control, internal audits, corrective and preventive actions (CAPA), risk management, training records, management review, supplier evaluation, and quality dashboards into one workspace. Teams can coordinate quality, environmental, and occupational health and safety activities, with workflows aligned to ISO requirements. AI-assisted features support document drafting and analysis, with generated content available for user review. SmartISO is intended for quality and HSE managers, compliance teams, and ISO consultants at small and mid-sized organizations. Plans vary by standards, storage, AI allowances, and other included features; a 14-day free trial is available.

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

Small and growing businesses in Life Sciences & Healthcare

Audience

Quality managers, HSE managers, compliance officers and ISO consultants at small and mid-sized organizations

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

No images available

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

Pricing

$39/month/user
Starter is $39 per user per month and includes ISO 9001, 5 GB storage, 50 AI calls per month, 10 client portal users, 2 external auditors, and email support. The site advertises 20% savings on annual billing. Professional is $79/user/month; Business is $119/user/month. All plans include a 14-day free trial; no credit card is required to start.
Free Version Not Supported
Free Trial Supported

Reviews/Ratings

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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Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported

Training

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

Company Information

Qualio
Founded: 2010
United States
www.qualio.com

Company Information

ODACITY LLC
Founded: 2024
United States
smartiso.io/

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QT9 QMS

QT9 QMS

QT9 Software
QT9 QMS

QT9 QMS

QT9 Software

Categories

Categories

ISO Compliance Supported

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

Azure AI Anomaly Detector Supported
Azure AI Document Intelligence Supported
Azure DevOps Labs Supported
Azure DevOps Server Supported
ComplianceWire Supported
Dynamics 365 Customer Service Supported
Essenvia Supported
GitHub Supported
GitHub Advanced Security Supported
GitHub Desktop Supported
GitLab Duo Supported
HubSpot CRM Supported
Intercom Supported
Microsoft 365 Supported
Microsoft Dynamics 365 Supported
Microsoft OneDrive Supported
RegDesk Supported
SSOJet Supported
Salesforce Supported
TestRail Supported

Integrations

Azure AI Anomaly Detector Not Supported
Azure AI Document Intelligence Not Supported
Azure DevOps Labs Not Supported
Azure DevOps Server Not Supported
ComplianceWire Not Supported
Dynamics 365 Customer Service Not Supported
Essenvia Not Supported
GitHub Not Supported
GitHub Advanced Security Not Supported
GitHub Desktop Not Supported
GitLab Duo Not Supported
HubSpot CRM Not Supported
Intercom Not Supported
Microsoft 365 Not Supported
Microsoft Dynamics 365 Not Supported
Microsoft OneDrive Not Supported
RegDesk Not Supported
SSOJet Not Supported
Salesforce Not Supported
TestRail Not Supported
Claim SmartISO and update features and information
Claim SmartISO and update features and information