Qualcy Systems
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All Products & Services
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
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.
We provide complete solution for Audit Management. This includes option for managing Internal Audits, Supplier Audits, 3rd Party Audits.
Qualcy Systems Reviews
Mark O.
Simple interface and easy to access the documents and records
Damek R.
Great tool for a startup or mid size medical device company.
About
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.