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GENERAL PRODUCT BROCHURES
Manage any type of audit activities, data, and processes while significantly reducing time and effort to support audit-readiness.
Build confidence and trust in measurement reliability with calibration management solution.
Orchestrate, track and document change across all functional areas of an organization.
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.
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.
AssurX Risk Management software facilitates risk scoring, identification, assessment, remediation, and prevention.
Supplier Quality Management
Manage suppliers, vendors, contract manufacturers, and service providers with one solution to enforce your quality and compliance goals.
RISK-BASED VALIDATION SOLUTION
Customized validation services based on a critical thinking approach that supports the GAMP 5 Model.
Training catalog with options for virtual classroom, onsite and e-learning with course descriptions.
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.
GMP AUDITS: MOVING FROM ADVERSARIAL TO COOPERATIVE
Regulated companies need audits to establish both compliance and performance, which go hand in hand.
Stay Informed with Content from our Experts
Linking Design Controls and Risk Management in the QMS
Design controls are a frequent citation in 483 observations [...]
Complaint Management for Life Sciences with an Automated QMS
Effective complaint handling is fundamental to life science [...]
AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)
AssurX will be exhibiting at this year’s ASQ World Confere [...]
Update: EU Medical Device Regulation Deadlines Extended
European Union (EU) Medical Device Regulation (MDR) and In- [...]
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 and compliance management processes with one software system. First, implement the solutions you need now, then easily connect more as you are ready. No other system is easier to deploy, configure, and modify.