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Qualcy Systems

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5 reviews
  • 3 profiles
  • 3 categories
Average star rating
4.7
Serving customers since
2014
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Qualcy Enterprise Quality Management System (EQMS)

5 reviews

Qualcy provides complete solution for Enterprise Quality Management System (commonly known as EQMS). Qualcy eQMS complies with 21CFR part11 requirements. Qualcy eQMS has been designed and developed by experienced professionals who understand the requirement of the Bio-Med and Life science companies, customers, suppliers and above all the regulatory requirements. Qualcy eQMS help the life science companies comply with 21CFR 820, 21 CFR210/211 requirements. We will take you through the smooth implementation of the systems and provide ongoing supports as needed. We provide complete documentation for the system operation and configuration. There is no additional programming needed. We provide user on boarding training for smooth roll out including IOQ validation reports. Our solutions include- Design Control, Risk Management Document Management and Change Control CAPA, Internal Audits, NC Management, Complaint Management Training system Management Eqp. Calibration and PM Management Supplier Quality Management, and others

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Qualcy CMMS

0 reviews

Qualcy CAL/PM Solutions is a solution that 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. It also helps manage the records PM, OOT.

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QMS Audit Management System

0 reviews

We provide complete solution for Audit Management. This includes option for managing Internal Audits, Supplier Audits, 3rd Party Audits.

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Qualcy Systems Reviews

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TG
Tamala G.
06/27/2025
Validated Reviewer
Verified Current User
Review source: Organic

Qualcy means quality!

The Qualcy team provides outstanding customer support. They are consistently responsive, thorough, and patient. Whenever I encounter a challenge within the system, I feel fully supported—with timely responses and the option to work through solutions via Zoom meetings. Sanjay, in particular, has been instrumental in getting me back on track quickly and effectively.
Verified User in Medical Devices
CM
Verified User in Medical Devices
06/05/2025
Validated Reviewer
Verified Current User
Review source: Organic

Qualcy is good for medical devices!

We really like the ability to do traceability between requirements docs within the eQMS. And the system is very comprehensive.
Ayan Y.
AY
Ayan Y.
08/15/2023
Validated Reviewer
Review source: Organic

Was a good experience

Mitigating Risks and Ensuring Compliance: The system's focus on risk assessment and compliance management is a crucial feature. Qualçy EQMS assists in identifying potential risks, implementing preventive measures, and ensuring adherence to industry regulations, mitigating risks to the business. Enhanced Collaboration and Communication: The platform's capability to foster collaboration across teams is highly beneficial. Qualçy EQMS breaks down communication barriers, enabling seamless information sharing and collective contribution to quality initiatives.

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HQ Location:
San Diego, US

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@QualcySystems

What is Qualcy Systems?

Qualcy Systems is a company specializing in providing quality management software solutions for life sciences industries, such as pharmaceutical and medical device companies. They offer a range of software products designed to support compliance with regulatory standards, including Good Manufacturing Practices (GMP), ISO 13485, and FDA requirements. Their software solutions help streamline processes related to document management, training management, non-conformance reporting, corrective and preventive actions (CAPA), and change management. Qualcy Systems focuses on improving efficiency and ensuring the integrity and traceability of critical quality processes in highly regulated environments.

Details

Year Founded
2014