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