Enterprise Quality Management System Software for Pharma and Biotech

AssurX quality management software system is designed to support requirements and standards for FDA regulated industries. The solutions seamlessly integrate, creating an ironclad closed-loop system to identify, track, resolve, document, and report all quality and compliance issues across every part of operations—even into the supply chain.

Using AssurX’s closed-loop quality management software, you not only know immediately when an issue arises (from any source: customer, supplier, internal), all relevant areas of your organization share the information needed to contain, evaluate and quickly resolve the problem. By utilizing powerful, real-time analytical tools, the software helps companies identify, assess, and remediate risk exposure, perform the detailed trend analysis needed to prevent quality and compliance problems, and continually improve operations. AssurX boasts mature compliance management capabilities with extensive audit trails, security controls, and electronic signature and records functionality that meets or exceeds rigorous standards of regulatory requirements.

Not only fully compliant with 21 CFR Part 11 and Part 820, but it is also flexible enough to keep you in compliance with changing cGXP requirements. AssurX’s preconfigured closed-loop solutions deliver fully FDA-compliant processes to manage audits, deviations, risk management, supplier quality, document control, corrective and preventive action (CAPA), change control, and more. In contrast, a state of control and proof of compliance is maintained continuously in one central, securely accessible system.

The AssurX software is validated and comes with IQ/OQ validation templates. Each preconfigured solution comes with a PQ based on industry best practices and the latest regulatory guidelines.