Resources
Brochures | Data Sheets | WHITE PAPERS
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AssurX Resource Center
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.
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.
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
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
Top 3 Most Violated NERC CIP Standards
According to the North American Electric Reliability Corpor [...]
Aligning Incident Management with ISO 45001 Requirements
The number of ISO 45001 certificates is growing fast, jumpi [...]
EHS Incident Management and Root Cause Analysis
Workplace safety incidents are a key driver of risk in manu [...]
Risk Management in ISO 13485
In December 2023, the U.S. Food and Drug Administration (FD [...]
AssurX: Quality & Compliance Systems for Every Enterprise
When you choose AssurX, you’re choosing decades of expertise in regulatory environments and 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 management and regulatory compliance management processes with one software system. AssurX provides all core quality and compliance processes within the software system, eliminating the need to budget for and install individual quality “modules.” Pre-configured workflows are available to you from day one.
First, implement the solutions you need now, then seamlessly connect more as you are ready. No other system is easier to deploy, configure, and modify.