“The benefits of AssurX have included easy implementation and a quick learning curve, as well as the visibility for all locations within the company. This has allowed for a new level of communication and trending that Spartech has not seen with our old processes.”

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Global Control of Quality for the High Tech Manufacturing Industry

High tech manufacturers are challenged with shorter product lifecycles, globalization of operations, and demand to move more complex products to market faster while maintaining the highest quality standards. The key to success is not just producing better products faster and more efficiently, the first time around. It also depends on controlling a multitude of complex processes with precision as you adapt to ever-changing requirements. These competitive times demand an easy to use solution to centrally monitor and manage quality-related operations across the enterprise with a streamlined, paperless system. AssurX is a flexible system of quality management software solutions that connects and automates quality related activities throughout the organization. The system enables issues that affect quality 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 poor quality, easily adapt and implement change, and drive operational excellence. The AssurX system is designed to support continuous improvement and compliance with cGxP, ISO 9000 for quality management systems and ISO 14000 for environmental management in manufacturing industries. (Also ISO 13485 and 14791 for medical device manufacturers). By identifying and resolving quality issues quickly—no matter where they arise—it reduces downtime and scrap and helps exceed customer expectations and continually improve product quality.

One Integrated System to Control Complex Operations With Exquisite Precision

FEATURES

The AssurX platform for global control of quality for manufacturing delivers fast,
efficient, cost-effective management.

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.

Control Across Operations

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

Improved Supplier Quality

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

The Right Information, Right Now

Instant enterprise-wide intelligence. 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.

Increase Customer Satisfaction

Quickly identifying and resolving product quality issues reported by customers consistently, including field service events, incoming calls, and product returns.

Ensured Compliance

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

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ASSURX QUALITY MANAGEMENT SYSTEM FOR HIGH TECH MANUFACTURERS

With AssurX, high tech manufacturers can gain integrated control.

Corrective and Preventive Action (CAPA)

AssurX automates and streamlines the CAPA process across operations. Issues initiated from any department are investigated, root causes identified, corrective/preventive actions planned and implemented across operations, and then evaluated for effectiveness. Control costs and improve products with 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.

Supplier Quality Management

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, the software lets you quickly detect, inspect, track and contain supplier related quality issues quickly and correct them before they become bigger issues.

Change Management

AssurX Change Management is a flexible, central system that orchestrates tracks and documents changes across all functional areas of a business. It creates a consistent, compliant, closed-loop method to process any type of 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 assigned and tracked; and then approved changes are released and implemented across operations. With easy, full integration to other quality related processes, it keeps coordinated control over changes across the organization.

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.

Document Management

AssurX’s solution provides built-in, easy and effective management of the controlled content life cycle from change orders through release approval, dissemination and training. Get rapid, secure access to current and accurate documents at all times. The system allows businesses to improve the global visibility of process changes and reduce the risk and labor costs associated with the use of erroneous and outdated procedures.

Customer Quality Management

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

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 and corrective action. It features proven best practice matrixes, management dashboards and strong audit trail reports and controls.

Audit Management

AssurX’s solution delivers a comprehensive audit management process and adheres to current best practices for closed-loop findings; closure, task assignments and escalation. Audits are conducted after being planned, findings are classified and follow-up is assigned to the right area managers. After follow-up actions are addressed, final reports are issued and routed for complete closure.

Compliance Management

Manage compliance for an array of requirements—from internal policies, to ISO, GMP, and customer mandated quality standards. By centrally monitoring, and coordinating activities, policies, procedures and documents, the software can consistently measure compliance status, and helps control risks associated with noncompliance, across all operations. Automated notification, escalation and remediation procedures proactively identify and resolve compliance gaps quickly. Dashboards provide a detailed real-time view into compliance status and trends.

AssurX OnDemand Solutions

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