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What is Qualcy QMS?

Qualcy Biomed's quality management system (QMS) software is tailored specifically for biomedical enterprises, such as those in biotechnology and pharmaceuticals, to effectively handle QMS documentation in line with FDA and ISO 13485 standards. It ensures adherence to 21 CFR Part 820 and incorporates essential features like electronic signatures, audit trails, and compliance with 21 CFR Part 11. Additionally, the software facilitates the management of document change control, complaint handling, audits, corrective and preventive actions (CAPA), non-conformance records, and training records, among other critical functions, ensuring a comprehensive solution for quality management. This robust platform ultimately supports organizations in maintaining high standards of compliance and operational efficiency in their quality processes.

What is CompliantPro?

CompliantPro's Quality Management System Software acts as an all-in-one solution that integrates a company's quality assurance requirements into a unified platform, successfully eliminating the complications caused by separate point solutions. This software enables organizations to effectively manage their compliance and regulatory responsibilities, offering features that go far beyond simple document management. Key areas of concentration include Environmental Health & Safety, Enterprise Risk Management, employee Training & Qualifications, Auditing processes, and the oversight of customer and supplier interactions. By harnessing the power of CompliantPro, businesses can optimize their workflows and significantly improve overall productivity. Furthermore, this software fosters a culture of continuous improvement, ensuring that quality assurance becomes an integral part of the organization's operations.

Media

Media

Integrations Supported

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

Integrations Supported

CommissionTrac

API Availability

API Availability

Pricing Information

$799 per month
Free Version
Free Trial Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Android
iPhone
iPad
Windows

Supported Platforms

SaaS
Windows

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
On-Site Training

Company Facts

Organization Name

Qualcy Systems

Date Founded

2014

Company Location

United States

Company Website

www.qualcy.com

Company Facts

Organization Name

Siemens

Date Founded

1847

Company Location

Germany

Company Website

siemens.com

Categories and Features

Calibration Management

Calibration Instructions
Calibration Schedules
Compliance Management
Due Date Tracking
Gage Management
Label Printing

Quality Management

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

Categories and Features

Calibration Management

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

Compliance

Archiving & Retention
Audit Management
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Version Control

EHS Management

Audit Management
Corrective / Preventive Actions
Environmental Management
Environmental Risk Assessment
Incident Management
Injury Reporting
Inspection Management
MSDS
OSHA Recordkeeping
Occupational Health Management
Safety Risk Assessment
Training Management
Waste Management

Quality Management

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

Risk Management

Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Internal Controls Management
Response Management
Risk Assessment

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