Average Ratings 1 Rating

Total
ease
features
design
support

Average Ratings 0 Ratings

Total
ease
features
design
support

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

Write a Review

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 

Screenshots View All

Screenshots View All

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 

Alternatives

Total Lean Management (TLM) Software Reviews

Total Lean Management (TLM) Software

Lean & Mean Business Systems

Alternatives

Xybion LIMS Reviews

Xybion LIMS

Xybion
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
SoftExpert EQM Reviews

SoftExpert EQM

SoftExpert