“The training was comprehensive, the support has been exceptional and the product has proven to be robust and flexible. We are extremely pleased with the success of this implementation”
Global QMS Software for the High Tech Manufacturing Industry
High tech manufacturers are challenged with shorter product life-cycles, globalization of operations, and demand to move 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.
AssurX is a flexible, easy-to-deploy 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 low quality, quickly 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, and ISO 13485 and 14791 for medical device manufacturers.
Automation reduces downtime by identifying and resolving quality issues without manual intervention. Exceed customer expectations, speed time to market, and continually improve product quality
One Integrated System to Control Complex Operations With Exquisite Precision
AssurX Quality Management System Features
The AssurX QMS platform for high tech manufacturing global quality control delivers powerful, cost-effective process management.
Fully Integrated CAPA
Centrally track, resolve, and document all product issues 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 change—process, product design, documentation -is processed from planning to global rollout 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. Live quality data shared instantly creates greater efficiency and gets your products to market faster and more predictably by reducing errors regardless of organizational complexity.
Increase Customer Satisfaction
Quickly identify and resolve product quality issues reported by customers consistently, including field service events, incoming calls, and product returns.
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.
Customer Case Study: Semiconductor Manufacturer
Learn how AssurX Cloud-Based FRACAS Solution Accelerates Root Cause Analysis and Improves Output for a US-based microelectronics manufacturer in the highly competitive semiconductor industry.
With AssurX Quality Management Software, 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 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 and correct them before becoming more significant issues.
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 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 control over the organization’s changes.
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.
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 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 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.
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 robust audit trail reports and controls.
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.
Manage compliance for various 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 of compliance status and trends.