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Description

Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals. QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations. Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included. Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com

Description

Introducing an eReg platform specifically tailored for study sites, it ensures rapid deployment without imposing rigid workflows, featuring a user-friendly design and functionality. Experience RegDoc eSafe free of charge today! This platform acts as a secure vault for source documents, equipped with tools that facilitate the transfer, redaction, and assignment of role-based, time-limited remote access to sensitive information. RegDoc eSafe boasts fast and flexible configuration options, requires minimal training for intuitive usage, and includes a comprehensive yet efficient validation process. The implementation is streamlined to quickly prepare your clinical study sites for operation. Additionally, regulatory binder templates are readily available within your site for convenient retrieval. The platform allows for user upload and access control settings, along with dedicated training sessions for both administrators and users. MedPoint prioritizes compliance, guiding you through all necessary procedures to validate our software effectively. With a wealth of experience in developing and supporting validated systems, MedPoint undergoes regular audits by study sponsors, ensuring the utmost reliability and quality in our offerings. Our commitment to continuous improvement and user satisfaction sets us apart in the industry.

API Access

Has API Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Microsoft Excel Yes 
Microsoft Outlook Yes 

Integrations

Microsoft Excel No 
Microsoft Outlook No 

Pricing Details

$10,000/year
Includes all 25+ Modules. Unlimited Training and Support Available. Get a quote today.
Free Trial Yes 
Free Version No 

Pricing Details

Contact MedPoint Digital for pricing details.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
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 No 
Live Rep (24/7) No 
Online Support No 

Types of Training

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

Types of Training

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

Vendor Details

Company Name

QT9 Software

Founded

2005

Country

United States

Website

qt9software.com/qms

Vendor Details

Company Name

MedPoint Digital

Country

United States

Website

www.medpt.com/site-services/

Product Features

Calibration Management

Calibration Instructions Yes 
Calibration Schedules Yes 
Compliance Management Yes 
Device History Yes 
Due Date Tracking Yes 
Gage Management Yes 
Label Printing Yes 
Measurement Readings Yes 
Multi-Station Management Yes 
Out-of-Tolerance Notification Yes 
Statistical Data Reporting Yes 

CAPA

Audit Management Yes 
CAPA Planning Yes 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis Yes 
Training Management Yes 

Compliance

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

Document Control

Archiving & Retention Yes 
Automated Routing Yes 
Change Management Yes 
Compliance Management Yes 
Electronic Signature Yes 
Escalation Management Yes 
Periodic Review Yes 
Version Control Yes 

Document Version Control

Access Controls/Permissions Yes 
Approval Process Control Yes 
Archiving & Retention Yes 
Audit Trail Yes 
Commenting / Notes Yes 
Document Check-in / Check-out Yes 
For Engineering Documents Yes 
Revision History Yes 
Version Comparison Yes 
Version Rollback Yes 

Inspection

Appointment Management Yes 
Customer Database Yes 
Dispatch Management Yes 
Equipment Tracking Yes 
Photos In Reports Yes 
Print on Site Yes 
Report Templates Yes 
Speech Recognition No 
Subcontractor 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 

Product Features

Document Control

Archiving & Retention No 
Automated Routing No 
Change Management No 
Compliance Management No 
Electronic Signature No 
Escalation Management No 
Periodic Review No 
Version Control No 

Document Management

Access Controls No 
Archiving & Retention No 
Collaboration Tools No 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly No 
Document Capture No 
Document Conversion No 
Document Delivery No 
Document Indexing No 
Document Retention No 
Electronic Signature No 
Email Management No 
File Recovery No 
File Type Conversion No 
Forms Management No 
Full Text Search No 
Offline Access No 
Optical Character Recognition No 
Print Management No 
Version Control Yes 

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