AssurX Quality Management Review

Quality management review (QMR) is a process within itself. It serves as a way for top management to review and evaluate the effectiveness of a quality management system (QMS) in order to determine its continued suitability and effectiveness. Furthermore, it facilitates changes to policy, objectives and other elements to further improve quality found during the review. When quality system health is taken seriously, better decisions are made and put into practice. Quality Management Review for Continuous Improvement AssurX Quality Management Review software helps guide the QMR process for any company, notably, regulated companies and those that adhere to ISO standards, including:

• FDA 21 CFR Part 820 for medical device firms
• International Conference on Harmonisation (ICH) Q10 guidance for pharmaceutical companies
• ISO 13485 for medical device firms
• ISO 9001 for ISO quality management standards AssurX software provides significant benefits in addition to satisfying external quality management review audit requirements. Beyond compliance, QMRs are opportunities to facilitate continuous quality improvement. With AssurX, automated workflows guide the review of outputs to confirm that the right processes are in place to optimize the quality value chain. Furthermore, management can review inputs and data and make improvements that align with corporate quality objectives.

Benefits

AssurX Quality Management Review software provides an automated process for conducting reviews and managing changes that may result from findings.

Compliance

Provide evidence of a formal QMR process for compliance with standards and regulations.

Centralize

Collect QMR data from across the organization in a single repository.

Process Automation

Increase accountability and efficiency through automated facilitation of all QMR tasks.

Control

A robust system provides unlimited KPIs and reporting needed for effective QMRs.

Flexibility

Integrate with other systems for full cycle visibility and collaboration.

Minimize Risk

Better manage risk by routing review outputs by criticality.

Continual Improvement

Establish a consistent, repeatable QMR process to identify and close quality gaps.

Visibility

Equip your team with robust dashboards that provide drill-down visibility into KPIs.

AssurX Quality Management Reviews Helps Organizations

• Substantiate that the quality management system is effectively updated, fit for purpose, and capable of adjusting to change.
• Plan a proactive quality management review schedule to keep the process on track.
• End information silos by connecting people, tasks, and processes with a closed-loop system for greater collaboration.
• Launch ad-hoc tasks when required.
• Request and capture signatures required for proper closure of QMR tasks.
• Integrate with CAPA, audit management, and other AssurX quality solutions for a turnkey system.

AssurX: Quality & Compliance Systems for Every Enterprise

The quality and compliance journey can be an obstacle course of changing regulations and standards in a dynamic global market. The AssurX enterprise quality management system (EQMS) and the AssurX Energy Compliance System (ECOS) help guide organizations through the complexities of any regulatory landscape. Our dynamic, connected quality and compliance management solutions help guide your journey by automating processes to streamline event management, minimize risk, measure performance and facilitate change. The result is a proactive system that improves efficiency, compliance readiness, product quality, and customer satisfaction.