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What is Sercle QMS?

Implementing Quality Management Software is vital for adhering to various ISO standards, such as ISO 9001, ISO 13485, ISO 17025, as well as FDA, GMP, and BRC regulations. This Enterprise Quality Management Software (EQMS) is adopted by numerous sectors, each possessing unique ISO demands, all aimed at elevating product quality and maintaining high standards. While certain EQMS solutions are designed primarily for large organizations, there are others specifically crafted for small to medium enterprises, yet they all encompass essential characteristics that exemplify the top quality management systems available. Businesses can incorporate methodologies like CAPA (Corrective Action Preventative Action) within their EQMS, and it is significant to recognize that the execution of these methodologies can greatly differ among companies, even those in the same sector. The ability to tailor workflows, forms, and layouts according to a company's specific needs is essential for achieving smooth integration of the system. Moreover, this customization not only supports compliance but also encourages a mindset of continuous improvement throughout the entire organization, ultimately enhancing overall operational efficiency. As organizations increasingly prioritize quality management, the role of adaptable software becomes more critical in navigating complex regulatory landscapes.

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.

Media

Media

Integrations Supported

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

Integrations Supported

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

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

$799 per month
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

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
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Sercle

Company Location

United States

Company Website

www.serclesoftware.com/quality-management-software/

Company Facts

Organization Name

Qualcy Systems

Date Founded

2014

Company Location

United States

Company Website

www.qualcy.com

Categories and Features

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

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

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