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Global Control of Quality for Manufacturing Industries

Manufacturers are challenged with increased competition, globalization of operations, and demand to quickly market products while maintaining the highest quality standards.

The key to success is producing better products faster and more efficiently, the first time around. These competitive times demand an easy to use solution to centrally monitor and manage quality across operations with a streamlined, paperless system.

AssurX Manufacturing QMS Software provides a system that connects and automates quality-related activities throughout the organization. The system enables quality issues to be quickly identified and resolved centrally—even across global operations and into the supplier network.

It helps manufacturers efficiently meet the highest quality standards for delivered goods, reduce costs associated with low quality, and drive operational excellence.

By identifying and resolving quality issues quickly—no matter where they arise—reduces downtime and scrap, helps exceed customer expectations, and continually improves product quality.

The AssurX Manufacturing QMS software system is designed to support continuous improvement and compliance with ISO 9000 for quality management systems and ISO 14000 for environmental management in manufacturing industries. (Also ISO 13485 and 14791 for medical device manufacturers, and ISO 22000 for food manufacturers).

AssurX Quality Management System Software Features

Fully Integrated CAPA

Automatically track, resolve, and document all product issues—initiated from any source, across all operations/functional areas—before they become costly problems. Reduce quality incidents and prevent recurrences. Control costs and make a better product the first time around.

Speed Time to Market

Speed time to market and reduce downtime by ensuring that any change—process, product design, documentation, etc.—is processed from planning to a global rollout in a consistent, closed-loop manner.

Ensured Compliance

A closed-loop, integrated system ensures issues are discovered, resolved, and documented entirely and quickly. Conduct internal audits, perform practical gap analysis, root cause analysis, and improve your ISO, Six Sigma, and Lean Manufacturing programs.

Improved Supplier Quality

Control quality with proactive, automated quality assurance among your vendors, suppliers, and contract partners. Identify and track supplier issues. Rate and rank performance using scorecards, launch CAPAs, and collaborate with them to resolve issues.

Global Efficiency & Oversight

Relevant, live quality data shared instantly creates greater efficiency and gets your products to market faster and more predictably by reducing errors—whether it’s a single shop or across large global operations.

Real-time Intelligence

Get real-time trending, analytics, and track KPIs using dashboards that deliver instant business intelligence. Monitor key performance indicators across all processes and drill down to the underlying data from any chart or report—in real-time, all the time—to improve compliance, customer satisfaction, risk exposure, and boost the bottom line.

AssurX Quality Management System for Manufacturing

Corrective and Preventive Actions (CAPA)

AssurX automates and streamlines the CAPA process across operations. Issues initiated from any department/source are investigated, root causes identified, corrective/preventive actions planned and implemented across operations, and evaluated for effectiveness. Control costs and improve your products while meeting requirements for closed-loop quality management. Because it’s fully integrated with other quality-related processes such as audits, nonconformance, customer complaints, change management, etc., no matter where an issue originates or how many departments the problem touches, the system can effectively manage its resolution.

Manufacturing Quality Management

Globally document, track, and resolve manufacturing related quality issues such as nonconformance, deviations, defects, incidents, exceptions, and change requests, from initiation through disposition, corrective action, and change execution. This closed-loop system is fully integrated with other quality and compliance processes and follows ISO and GMP standards for best practices. Track trends, cycle times, and costs to facilitate root cause analysis and improve efficiency.

Supplier Quality Management (SQM)

The AssurX solution offers instant collaboration and visibility across your supplier network to vastly improve product quality. No matter the number or location of your suppliers and contract manufacturers, SQM lets you quickly detect, inspect, track, and contain supplier-related quality issues and correct them before becoming more significant issues.

Customer Quality Management

Improve customer satisfaction and retention rates by quickly resolving product quality issues reported by customers in a consistent, predictable manner. Quality issues from customer-related sources are logged and investigated, and returns are processed. Root causes are identified, and corrective/preventive actions are launched across operations and then checked for effectiveness. The system includes management of complaints, issues arising from field service events, incoming calls, and product returns.

Document Management

Creates a central library where critical documents are stored and manages the document lifecycle, including change requests, redlining; approval routing; release, notification, and training. Get rapid, secure access to current and accurate documents at all times. The solution is fully integrated with quality and audit-related processes. The system allows businesses to improve the global visibility of process changes, reduce risk and labor costs associated with erroneous and outdated procedures, and meet ISO documentation requirements.

Change Management

One central system orchestrates, tracks, and documents changes across all functional areas of your business. AssurX creates a consistent, compliant closed-loop method to process any change (e.g., business process, product design, documentation, etc.). Proposed changes initiated from any department are evaluated; change plans are mapped out; tasks, reviews, and approvals are assigned and tracked; then approved changes are released and implemented across operations. With easy, full integration to other quality-related processes, it keeps coordinated, compliant control over the organization’s changes.

Complaints Management

The AssurX Complaints Management system provides a best practices process for managing the entire event lifecycle from event intake through investigation, root cause analysis. It features proven best practice matrixes, management dashboards, and robust audit trail reports and controls.

Audit Management

AssurX’s solution delivers a comprehensive audit management process and adheres to best practices and current ISO requirements. Plan, schedule, and manage internal quality and compliance audits, end-to-end, in a closed-loop workflow. Automatically log/classify audit findings, assign follow-up activities, manage responses, and launch corrective actions.

Risk Management

Determine, assess, prioritize, and manage enterprise risk to meet compliance objectives and drive operational excellence. Perform evaluations of financial, brand, operational, and compliance impact; and plan and monitor risk mitigation activities. Real-time graphical dashboards deliver risk and activity status, threat heat maps, and detailed trending and analysis metrics. The system seamlessly integrates with corrective action and change management software to automatically launch and track the resolution of any issues—preventing avoidable threats and reducing overall risks.

Training Management

Take charge of all training requirements, activities, materials/courses, and histories throughout your organization. Quickly identify “who-needs-what” training even in complex, changing environments. The AssurX solution ensures your personnel is always effectively trained for the job, all training is documented correctly, and training histories are accessible and auditable.