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Manufacturing Quality Management Software

AssurX Enterprise Quality Management System (EQMS) for Manufacturers

Many fabrication and processing manufacturers have not yet moved away from paper-based and manual processes. Implementing a manufacturing quality management system (QMS) guides adherence to ISO 9001 standards to reduce errors and provide a greater level of quality assurance to consumers and stakeholders.

AssurX manufacturing quality management system automates quality processes within a centralized platform between and quality improvement. It eliminates burdens associated with manual processes through:

All core quality processes exist within the AssurX enterprise quality management system. Start with the solutions you need now, and integrate new processes when you’re ready. No other system is easier to deploy, configure, and modify.

AssurX offers built-in tools to create robust workflows that meet your specific process mapping with no changes to the underlying code.

AssurX replaces paper-based systems that are prone to outdated or missing documentation, unstructured data, and excessive amounts of time to manage.

AssurX analytics and dashboards replace spreadsheets for visibility into real-time data and performance metrics across the organization.

Workflows are formalized to create an unbreakable chain of tasks with controls in place to escalate issues and track them to completion.

AssurX QMS for manufacturing provides cutting-edge analytics and reporting tools to help you identify quality issues throughout the product lifecycle. The system makes data collection and analysis easier to provide clear insights into all your quality processes.

AssurX provides electronic signature capability  that meets FDA 21 CFR Part 11 requirements. In addition, the system automatically captures all changes made to records using a secure, time-stamped audit trail.

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AssurX: Leading Quality Software for the Manufacturing Industry

AssurX is aligned with ISO 9001 standards for quality management systems and uses best practices from 20 years of real-world experience.

The AssurX quality management platform creates a closed-loop system that captures all quality activities. An electronic quality management system (EQMS) is the hub of building and maintaining a quality culture that is focused on preventing errors, ensuring compliance with any applicable regulations and standards, and making improvements throughout the manufacturing cycle.

The AssurX manufacturing quality management platform integrates core quality processes, including customer quality management, CAPA, deviations/investigations,  document control, training management, audit management, and change management. Having a single repository for all quality documents enables users across your organization to quickly find the information they need.

AssurX Manufacturing Quality Management System: Benefits of an Integrated Platform

AssurX is designed to increase efficiency and productivity as well as foster continuous quality improvement. For robust quality control and quality assurance in manufacturing, the system facilitates:

Proactive Quality

Processes are controlled and flexible to implement a risk-based approach to quality, which can identity, track, and often prevent quality issues that could potentially impact quality of product and public reputation.

Supplier Management

Create a structured process for supplier quality management to respond to any disruptions quickly. Visualize supplier performance metrics, respond to issues faster, and perform supplier audits when necessary. Integrate with document management and training management to further enforce your quality and compliance guidelines.

Document Control

Manage the entire document control lifecycle seamlessly with the help of robust routing, revision, escalation, and approval features. Initiate training when documentation is created or updated. All information (qualification, audits, deviations, SCARs, etc.) will be stored in a centralized repository for easy tracking and retrieval.

Training and Testing

Employee competency and skills can be measured and documented and used to identify areas for improvement. Proper training helps users avoid errors, the most common cause of deviations and nonconformances. Demonstrate competency and training compliance during audits and inspections.

Risk Management

Use the data to identify and mitigate supplier risks, including evaluation of supplier performance and pinpointing quality issues.

Faster Path to Root Cause Analysis

The failure modes and effects analysis (FMEA) process is applied within the system to help determine root causes for defects. Use FMEA to find likely failure points to investigate and assess whether existing controls for are effective at addressing root causes of problems.

Maximize the Value of Your Enterprise Data

Much of the data you need may reside in legacy systems or other enterprise applications. AssurX is designed to enable you to maximize data value within the platform for even greater economy of scale.

Data Migration

Migrate and leverage existing data with automated tools to extract the data from your legacy system(s) and import virtually any type of data. Your data types are properly converted and mapped to your operations.

Enterprise System Integration

The AssurX quality management system (QMS) connects with enterprise systems within your business and the extended value-chain. AssurX solutions integrate with enterprise applications such as ERP, MES, CRM, and CMMS.

Connect teams, suppliers, customers, and other stakeholders under a centralized, end-to-end platform for better collaboration and to realize a reduced cost of quality (CoQ).

Resources for Manufacturing Management System

AssurX Partnerships

AssurX Change Control Solution Demo

AssurX Partnerships

AssurX Change Control Data Sheet

AssurX Partnerships

QMS Automaton White Paper Link

AssurX Partnerships

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