Automate Investigations to Maximize Patient Safety
Proactively Manage Risk and Potential Quality Impact
Deviation Management Software for Regulated Companies
AssurX Deviation Management Software provides an automated solution to capture, investigate, and disposition planned and unplanned deviations and nonconformances. Fully configurable, best practices workflows speed the identification of the deviation source anywhere in the quality value chain. Track and manage a wide range of deviations from initiation, through investigation and root cause analysis, to CAPAs and resulting change controls.
Understand and control process deviations and product nonconformances to avoid regulatory action and financial losses that can compromise to your brand. Maintain compliance with regulations and standards for deviations and nonconformances including, but not limited to:
AssurX provides a single source of truth to capture, investigate, and disposition planned and unplanned deviations. Improve time to resolution and gain insights to help continually improve processes and produce higher quality products.
Comprehensive Deviation Management Features and Functionality
AssurX enables rigorous and timely management of deviations with configurable workflows that align with your business needs. As a result, deviation investigations follow a pre-defined process that improves time to resolution and compliance posture, as well as gain insights that enable you to continually improve processes and product quality. Streamline the deviation management process, minimize errors, and facilitate compliance.
Integrate deviation management software with external enterprise applications including ERP, MES, batch release systems, and other systems with a robust, open interface. Exchange information bi-directionally with suppliers, development, and other departments.
PLATFORM
AssurX core quality processes are available to you from day one. This allows your organization to build out and integrate processes as your quality plan expands or as change requires.
CONFIGURABILITY
Highly configurable, zero-code process workflows provide an environment that is scalable and flexible to meet changing business needs.
EFFICIENCY
Automated alerts, escalations, dashboard functionality, and extensive reporting capabilities keep the process moving on-time with enterprise-wide visibility.
ACCOUNTABILITY
Integrated tasks, assignments, signatures, and audit trails keep your users accountable and in compliance with regulatory guidelines.
STANDARDIZATION
Decrease the likelihood of repeat errors with the help of built-in decision trees and drill-down selections for multi-level investigations and root cause analysis.
FMEA–ROOT CAUSE ANALYSIS
A process-driven, step-by-step failure mode and effects analysis (FMEA) is available within AssurX to identify all potential causes of a deviation.
RISK CONTROLS
Data entered into the deviation record generates a risk priority number (RPN) based on your designated risk factors that include severity, occurrence, and other factors.
VISIBILITY
Configurable dashboards, reports and analytical data provide clear insights in the status of open deviations, trends, and the effectiveness of risk management.
Watch a 6 Minute Video of the AssurX Deviation Management Solution Now
See how the AssurX Deviation Management Solution provides a single source of truth to capture, investigate, and correct deviations, regardless of source or type. Workflows are also highly configurable to adapt to the specific needs of your organization.
Benefits of AssurX Deviation Management Software
TRUSTED BY GLOBAL COMPANIES FOR OVER 20 YEARS
AssurX: Connected Quality and Validated Compliance
AssurX provides expert technical and program management oversight for customer installs around the globe. We use a proven implementation process that provides a consistent method for architecture design.
Data Migration
Our experts are experienced with a host of different methods for performing migrations, from direct migration using AssurX import tools, to building data warehouses that used for robust reporting.
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.
