The AssurX Platform: Enterprise Quality Management and Regulatory Compliance for Every Enterprise

One flexible system of integrated QMS solutions handles any quality or compliance process, making quality management and regulatory compliance tasks simple, transparent, and automated. Utilize actionable data and trending for continuous improvement of your quality management system.
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QUALITY MANAGEMENT SOFTWARE IN A SINGLE, RELIABLE PLATFORM

The AssurX platform is a versatile software solution for quality management and regulatory compliance to reliably communicate and coordinate information, documentation, and activities across the enterprise. AssurX allows regulated businesses to quickly identify and control risk exposure and avoid quality or noncompliance problems while improving workflow.

 

AssurX quality management software is uniquely configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. Begin with just the solutions and functionality you need now, then implement what you like whenever you’re ready. No other system is easier to deploy, configure, and modify.

“AssurX is a highly configurable enterprise Quality Management System (QMS) which allows us to bring all of our Quality System processes under one enterprise solution. “

– Manager, Quality Operations

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A CONFIGURABLE, SCALABLE EQMS THAT ENABLES CONTINUOUS
QUALITY IMPROVEMENT

The robust AssurX Platform is rich in features and that make critical quality management and regulatory compliance tasks simple, transparent, and automated.

Single Platform

One seamlessly connected solution to improve quality, ensure compliance, manage risk, and streamline workflow.

EFFORTLESS STABILITY

Simple to deploy, configure, use, and modify.

Streamlined Activities

Automatically orchestrate and track activities, share data, and communicate information to the appropriate parties.

COMPLETE ANALYTICS

Powerful real-time trending and analytical tools.

A PROACTIVE APPROACH TO QUALITY

Identify and resolve issues quickly using risk-based approach. Drive continuous improvement using findings and actionable intelligence.

EFFICIENT MANAGEMENT

Manage operations while detecting, correcting, and preventing potential issues.

COMPLETE TRANSPARENCY

Dashboards provide live, clear views of coordinated activities and information across all areas of the business.

SERVICE OPTIONS

Available in the AssurX Cloud or as a server-based on-premise solution.

ENTERPRISE SYSTEMS INTEGRATION

Integrate with unlimited enterprise applications such as ERP, PLM, MES, LIMS, CRM, and others.

Control activities and data with complete visibility.
Know immediately when an issue arises. Evaluate and resolve problems quickly.

ONE QUALITY MANAGEMENT SYSTEM HANDLES EVERY PROCESS

AUDIT MANAGEMENT

Maintain controlled and efficient audits while automatically recording information for easy retrieval, trend tracking, and identification.

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COMPLIANCE MANAGEMENT

Automate, track, and manage all compliance-related activities—from documentation to mitigation and reporting.

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DOCUMENT MANAGEMENT

Manage your entire document lifecycle—from creation and revision to training—in one central repository.

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RISK MANAGEMENT

Identify and evaluate risks associated with business objectives. Manage controls, testing, and mitigation activities to increase visibility, prioritize, and limit risk exposure.

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TRAINING MANAGEMENT

Automatically ensure proper training compliance in complex, fluid environments.

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CHANGE MANAGEMENT

Process any proposed change and efficiently manage its evaluation, planning, implementation, and documentation across every part of your operation.

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CORRECTIVE & PREVENTIVE ACTION (CAPA)

Capture issues or incidents from any source and efficiently manages their resolution across every part of your operation—from detection through the closure and trend analysis.

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SUPPLIER QUALITY MANAGEMENT

Monitor and audit your supplier base, track and resolve issues with purchased goods in receiving, production, and the field to improve supplied product quality and supplier performance.

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DEVIATION MANAGMENT

Manage deviation/non-conformance process throughout the product lifecycle as required for Good Manufacturing Processes (GMP) and other regulatory and business requirements.

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COMPLAINT MANAGEMENT

Efficiently process complaints across operations from intake to investigation, reporting assessment, root cause analysis, corrective action and regulatory reporting.

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CUSTOMER QUALITY MANAGEMENT

Efficiently manage the processing of customer reported quality issues from intake through resolution.

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MANUFACTURING QUALITY MANAGEMENT

Process quality incidents from detection through investigation, disposition, corrective actions and change control.

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PATCH COMPLIANCE MANAGEMENT

AssurX Patch Compliance Management is a configurable software solution that solves the security challenge of managing asset patching across IT, OT, and IoT infrastructures.

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CALIBRATION MANAGEMENT

AssurX Calibration Management allows manufacturers to quantify, control, and demonstrate acceptable device measurements in one centralized location.

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