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GENERAL PRODUCT BROCHURES
SOLUTION DATASHEETS
Audit Management
Manage any type of audit activities, data, and processes while significantly reducing time and effort to support audit-readiness.
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.
Deviation ManagemenT
Efficiently find root cause and apply corrective actions to minimize the risk of problem recurrence.
EHS Incident Management
Overview of the AssurX automated electronic medical device reporting solution.
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
AssurX electronic reporting solution automates the EU Manufacturer Incident Reporting (MIR).
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
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.
AssurX: Quality & Compliance Systems for Every Enterprise
When you choose AssurX, you’re choosing more than two decades of expertise in regulated environments and continuous innovation in quality management. Our unwavering focus on quality management means you’re getting a best-of-class solution, not a scaled down or inflexible software solution.






One Platform. Every Solution.
Seamlessly integrate all quality and compliance processes with one software system. Start by using just the solutions you need now, then easily add more as you are ready. No other system is easier to deploy, configure, and modify.