Qualcy QMS

Qualcy QMS

Qualcy Systems
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About

Qualcy Bio-Med QMS Software has been designed for Bio-Medical companies (including Biotech, Pharma and Medical Device) to manage QMS records for ISO13485 and FDA requirements. * Designed for meeting the requirements for 21 CFR Part 820 * Has built in features for E-sign, audit trails and complies with 21 CFR part 11 requirements. This software helps manage the records for Doc. change control, complaints, audits, CAPA, NC Records, Training Records and more.

About

ZenQMS is an AI-enabled electronic Quality Management System (eQMS) built for life sciences and GxP-regulated organizations, including biotech, pharma, CROs, and CMO/CDMO companies. The cloud-based, fully validated platform supports document control, training management, audits, supplier management, CAPA management, quality data intelligence, and compliance with FDA 21 CFR Part 11 and ISO standards. Unlike legacy systems, ZenQMS is designed for companies of all sizes to be easier to use, quicker to validate, and more effective at managing GxP activities. ZenQMS supports key quality processes, including: Document management/document control Training management and learning management CAPAs (Corrective and Preventive Actions) Deviations, nonconformances, complaints, issues, and other quality events Change controls Audit management Supplier and vendor management Electronic signatures with 21 CFR Part 11-compliance Risk management Quality metrics tracking and reporting

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Bio-Medical companies (including Biotech, Pharma and Medical Device)

Audience

Life Sciences organizations, such as Biotech, Pharma, CRO, CMO/CDMO, Logistics, Labs, and more

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

$799 per month
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 4.0 / 5
support 5.0 / 5

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

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Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Qualcy Systems
Founded: 2014
United States
www.qualcy.com

Company Information

ZenQMS
Founded: 2010
United States
www.zenqms.com

Alternatives

Alternatives

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Total Lean Management (TLM) Software

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Total Lean Management (TLM) Software

Total Lean Management (TLM) Software

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Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
QT9 QMS

QT9 QMS

QT9 Software
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences

Categories

Categories

Quality Management Features

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

Calibration Management Features

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

Quality Management Features

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

Integrations

Microsoft Azure
AWS Backup
AWS Cloud9
Gmail
Microsoft 365
Microsoft Outlook
Okta
Res_Q
SAP Analytics Cloud

Integrations

Microsoft Azure
AWS Backup
AWS Cloud9
Gmail
Microsoft 365
Microsoft Outlook
Okta
Res_Q
SAP Analytics Cloud
Claim Qualcy QMS and update features and information
Claim Qualcy QMS and update features and information
Claim ZenQMS and update features and information
Claim ZenQMS and update features and information