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AssurX Resource Center
GENERAL PRODUCT BROCHURES
SOLUTION DATASHEETS
Assurx Analytics
Utilize real-time live data, so you are always analyzing the current data, rather than time-late warehoused information.
Audit Management
Manage any type of audit activities, data, and processes while significantly reducing time and effort to support audit-readiness.
Calibration Management
Build confidence and trust in measurement reliability with calibration management solution.
Change Management
Orchestrate, track and document change across all functional areas of an organization.
Complaint Management
Manage postmarket adverse events and OOS while improving compliance, product safety and product innovation.
Corrective and Preventive Actions (CAPA)
Create a clear path to resolution and prevention through root cause analysis of nonconformances, system, or process failures.
Design Control
Ensures medical devices designed and manufactured meet specified compliance requirements and necessary design control phases are addressed.
Deviation ManagemenT
Efficiently find root cause and apply corrective actions to minimize the risk of problem recurrence.
EHS Incident Management
Elevate your quality and safety standards with systematic and detailed investigations.
ELECTRONIC MEDICAL DEVICE REPORTING (eMDR)
Overview of the AssurX automated electronic medical device reporting solution.
EU MIR SUBMISSION
AssurX electronic reporting solution automates the EU Manufacturer Incident Reporting (MIR).
Quality Management Review
Conduct through and standardized evaluations of QMS suitability and effectiveness.
PATCH COMPLIANCE MANAGEMENT
Patch Compliance Management helps manage critical infrastructure protection as part of a defense in depth strategy.
Risk Management
AssurX Risk Management software facilitates risk scoring, identification, assessment, remediation, and prevention.
VALIDATION BROCHURES
SERVICES
WHITE PAPERS
HOW TO RESPOND TO FDA FORM 483 AND AVOID A WARNING LETTER
Receiving an FDA Warning Letter can have devastating consequences, including the negative impact on the company’s regulatory standing, operations, revenue and brand reputation.
VALIDATING QUALITY MANAGEMENT SYSTEMS: BEST PRACTICES FOR COMPLIANCE SUCCESS
Neglecting compliance can result in costly delays, recalls, or unfavorable audit outcomes, potentially damaging your business’s reputation and bottom line.
HOW TO SAFEGUARD YOUR CAPA PROCESS FROM STAKEHOLDER FAILURES
Where CAPA programs often fail are in stakeholder engagement and accountability.
BRIDGING THE QUALITY MANAGEMENT DIGITAL DIVIDE
High-performing manufacturers can bridge the gap in real-time, with immediate access to actionable insights from a QMS.
SYSTEM INTEGRATION WHITE PAPER
This System Integration white paper details and compares methods for enterprise quality system integration.
21 CFR PART 11 COMPLIANCE BULLETIN
This AssurX System Integration white paper details and compares methods for enterprise quality system integration.
DISPELLING COMMON MISCONCEPTIONS ABOUT SOFTWARE VALIDATION
This solution brief addresses common myths and misconceptions about computer system validation.
6 ELEMENTS OF A MODERN CHANGE MANAGEMENT SYSTEM
Learn the requirements for a Modern Change Management System.
Stay Informed with Content from our Experts
AssurX Unveils the Next Generation of ECOS-GRC: A Comprehensive Governance, Risk, and Compliance Solution for the Energy, Utility, and Critical Infrastructure Industry
Reno, NV April 8, 2025 – AssurX, a leading provider of quality and compliance management software s [...]
Understanding the Differences Between Deviation vs. Nonconformance
The pharmaceutical industry and the medical device industry have unique ways of defining terms like [...]
How to Use a Risk Matrix to Ensure Effective Risk Management
In manufacturing and in life, we can never completely eliminate risk. What matters is how you manag [...]
3Analytics Partners With AssurX to Revolutionize IMDRF Coding Using AI
The IMDRF Coding solution integrates seamlessly into AssurX EQMS, ensuring compliance with EU MDR a [...]
AssurX: Quality & Compliance Systems for Every Enterprise
The quality and compliance journey can be an obstacle course of changing regulations and standards in a dynamic global market. The AssurX enterprise quality management system (EQMS) and the AssurX Energy Compliance System (ECOS) help guide organizations through the complexities of any regulatory landscape.
Our dynamic, connected quality and compliance management solutions help guide your journey by automating processes to streamline event management, minimize risk, measure performance and facilitate change. The result is a proactive system that improves efficiency, compliance readiness, product quality, and customer satisfaction.
One Platform. Every Solution.
Easily integrate all your quality management and regulatory compliance processes into a single quality software system with AssurX. AssurX provides all core quality and compliance processes within the software system. This removes the need to budget for and install individual quality “modules.” Pre-configured workflows are available to you from day one with our quality management software.
Benefit from pre-configured workflows right from the start, ensuring a smooth transition to digital quality management. AssurX is an exceptional platform that facilitates transitioning from a labor-intensive, paper-based process to a streamlined electronic system. By adopting AssurX, you can embrace the enhanced organization that comes with digitizing documents and files.
With AssurX, enjoy the convenience of easily searchable data, allowing for quick retrieval and efficient information management, and saving valuable time. AssurX stands out as a user-friendly platform that allows for easy deployment, configuration, and integration with other software solutions.
First, implement the solutions you need now, then seamlessly connect more as you are ready. No other quality management system is easier to deploy, configure, and modify. Integrations with other software solutions make AssurX invaluable. Bid farewell to data silos and welcome a unified system for maximum efficiency.