Average Ratings 1 Rating
Average Ratings 0 Ratings
Description
Qualcy Biomed QMS Software was designed for Bio-Medical businesses (including Biotech and Pharma) to manage QMS records in accordance with FDA and ISO13485 requirements. * Meets 21 CFR Part 820 requirements * Features include E-sign, audit trails, and compliance with 21 CFR part 11. This software manages Doc. Change control, complaints, audits CAPA, NC Records Training Records and many more.
Description
iPassport is an advanced software solution tailored for healthcare laboratories, aimed at enhancing the digitization, organization, and overall management of quality and compliance on a daily basis. This platform offers a comprehensive array of quality management modules, making it simple to oversee various aspects, from document control to employee training. All controlled documents are conveniently centralized, complete with designated access and editing permissions, alongside thorough revision histories. It encompasses everything necessary to manage both internal and external audits effectively. Users can record and oversee non-conformities, corrective actions, and incidents, while also managing staff training, competencies, tasks, meetings, and leave. Additionally, it features a robust supplier database and auditing tool that includes performance evaluations. The system also allows for efficient management and tracking of assets and inventory, including comprehensive maintenance records for equipment. With iPassport, healthcare laboratories can ensure operational efficiency and compliance with regulatory standards.
API Access
Has API
No
API Access
Has API
No
Integrations
AWS Backup
Yes
AWS Cloud9
Yes
Gmail
Yes
Microsoft 365
Yes
Microsoft Azure
Yes
Microsoft Outlook
Yes
SAP Analytics Cloud
Yes
Integrations
AWS Backup
No
AWS Cloud9
No
Gmail
No
Microsoft 365
No
Microsoft Azure
No
Microsoft Outlook
No
SAP Analytics Cloud
No
Pricing Details
$799 per month
Free Trial
Yes
Free Version
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
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)
Yes
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
Qualcy Systems
Founded
2014
Country
United States
Website
www.qualcy.com
Vendor Details
Company Name
Genial Genetic Solutions
Country
United Kingdom
Website
www.genialcompliance.com/products/ipassport/
Product Features
Calibration Management
Calibration Instructions
Yes
Calibration Schedules
Yes
Compliance Management
Yes
Device History
No
Due Date Tracking
Yes
Gage Management
Yes
Label Printing
Yes
Measurement Readings
No
Multi-Station Management
No
Out-of-Tolerance Notification
No
Statistical Data Reporting
No
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
Medical Lab
Audit Trail
No
Data Analysis Auditing
No
Data Security
No
EMR Interface
No
Fax Management
No
Lab Instrument Interface
No
Multi-Location Printing
No
Online Instrumentation
No
Physician Test Panels
No
Procedure-Based Billing
No
Sample Tracking
No
Quality Management
Audit Management
No
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No