Learn More

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 919 Ratings

Description

1factory's Manufacturing Quality is a versatile quality control software designed for manufacturing businesses of various scales, available in both cloud-based and on-premises formats. This robust and dependable solution offers a comprehensive suite of features, including first article inspections, factory monitoring, quality control plans, as well as in-process and final inspections. Furthermore, it also covers incoming inspections, inspection management, corrective and preventive actions (CAPAs), and non-conformance tracking, among others. Additional noteworthy functionalities comprise the ability to perform metrics calculations for Process Performance (Pp, Ppk) and Process Capability (Cp, Cpk), along with managing variation and SPC control, as well as monitoring defect risks effectively. By integrating these capabilities, 1factory’s Manufacturing Quality ensures that manufacturers maintain high standards of quality throughout their operations.

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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Arena PLM Yes 
Azure AI Anomaly Detector No 
Azure AI Document Intelligence No 
Azure DevOps No 
Azure-AD-External-Identities No 
Essenvia No 
GitHub Advanced Security No 
GitLab No 
Google Cloud Operations Suite No 
HubSpot CRM No 
Intercom No 
Microsoft 365 No 
Microsoft Dynamics 365 No 
Okta No 
RegDesk No 
SSOJet No 
Salesforce No 
TestRail No 
Zendesk No 
Zephyr No 

Integrations

Arena PLM No 
Azure AI Anomaly Detector Yes 
Azure AI Document Intelligence Yes 
Azure DevOps Yes 
Azure-AD-External-Identities Yes 
Essenvia Yes 
GitHub Advanced Security Yes 
GitLab Yes 
Google Cloud Operations Suite Yes 
HubSpot CRM Yes 
Intercom Yes 
Microsoft 365 Yes 
Microsoft Dynamics 365 Yes 
Okta Yes 
RegDesk Yes 
SSOJet Yes 
Salesforce Yes 
TestRail Yes 
Zendesk Yes 
Zephyr Yes 

Pricing Details

Starts at $40 per user, per month
Free Trial Yes 
Free Version Yes 

Pricing Details

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 Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

1factory

Founded

2011

Country

United States

Website

www.1factory.com

Vendor Details

Company Name

Qualio

Founded

2010

Country

United States

Website

www.qualio.com

Product Features

Quality Management

Audit Management No 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
Supplier Quality Control Yes 
Training Management No 

Product Features

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) Yes 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing Yes 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance Yes 
ISO Compliance Yes 
Incident Management Yes 
OSHA Compliance No 
Risk Management Yes 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control Yes 
Workflow / Process Automation Yes 

Policy Management

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

Quality Management

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

Alternatives

Harrington Quality Management Software (HQMS) Reviews

Harrington Quality Management Software (HQMS)

Harrington Group International

Alternatives

Propel Reviews

Propel

Propel Software
SoftExpert EQM Reviews

SoftExpert EQM

SoftExpert
QT9 QMS Reviews

QT9 QMS

QT9 Software
isoTracker Quality Management Reviews

isoTracker Quality Management

isoTracker Solutions Ltd