EtQ's QMS for Life Sciences is an integrated quality management and FDA Compliance Software system that exceeds GMP standards, including ISO 13485, ISO 14971 and 21 CFR Part 11 compliance requirements. EtQ's unique modular approach provides unparalleled flexibility and automation. These modules are tightly integrated to deliver a best-in-class GMP Compliance Software solution that will improve compliance and quality for your industry.
A QUALITY MANAGEMENT SYSTEM IS A FORMALIZED SYSTEM THAT DOCUMENTS THE POLICIES, PROCEDURES, DOCUMENTATION REQUIREMENTS, AND PROCESSES THAT MEDICAL DEVICE COMPANIES USE TO ENSURE THAT THEIR PRODUCTS ARE BOTH SAFE AND EFFECTIVE FOR THE END USER.