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 Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

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 Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

$799 per month
Free Version Supported
Free Trial Supported

Pricing

ZenQMS does not charge per seat license, allowing you to grow without sacrificing compliance. Our pricing is simple and transparent, and is based on the complexity of the account and initial migration/configuration activity. Contact ZenQMS today for more details.
Free Version Not Supported
Free Trial Not Supported

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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Pros & Cons from Real Users

Pros

  • Simple and easy to manage the document change controls. Integrated training module automates the training records. The QMS package comes with calibration and asset management module, which is a big plus.

Cons

  • It took us little longer than expected to get started. It has been a good experience so far.

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

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

Company Information

ZenQMS
Founded: 2010
United States
www.zenqms.com

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Categories

Categories

Quality Management Features

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

Calibration Management Features

Calibration Instructions Supported
Calibration Schedules Supported
Compliance Management Supported
Device History Not Supported
Due Date Tracking Supported
Gage Management Supported
Label Printing Supported
Measurement Readings Not Supported
Multi-Station Management Not Supported
Out-of-Tolerance Notification Not Supported
Statistical Data Reporting Not Supported

Quality Management Features

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

Integrations

Microsoft Azure Supported
AWS Backup Supported
AWS Cloud9 Supported
Gmail Supported
Microsoft 365 Supported
Microsoft Outlook Supported
Okta Not Supported
Res_Q Not Supported
SAP Analytics Cloud Supported

Integrations

Microsoft Azure Supported
AWS Backup Not Supported
AWS Cloud9 Not Supported
Gmail Not Supported
Microsoft 365 Not Supported
Microsoft Outlook Not Supported
Okta Supported
Res_Q Supported
SAP Analytics Cloud Not Supported
Claim Qualcy QMS and update features and information
Claim Qualcy QMS and update features and information
Claim ZenQMS and update features and information
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