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:

CGMP Regulations

Pharma/Biological Products

21 CFR Part 11

Electronic Records; Electronic Signatures

ISO 9000

Quality Management Systems


Pharmaceutical Quality System

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.


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.


Highly configurable, zero-code process workflows provide an environment that is scalable and flexible to meet changing business needs.


Automated alerts, escalations, dashboard functionality, and extensive reporting capabilities keep the process moving on-time with enterprise-wide visibility.


Integrated tasks, assignments, signatures, and audit trails keep your users accountable and in compliance with regulatory guidelines.


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.


A process-driven, step-by-step failure mode and effects analysis (FMEA) is available within AssurX to identify all potential causes of a deviation.


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.


Configurable dashboards, reports and analytical data provide clear insights in the status of open deviations, trends, and the effectiveness of risk management.

AssurX Deviation Management Demonstration

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

Demonstrate a structured, repeatable method to identify defects or changes in product quality, as well as activities done to eliminate the issue. Integrate CAPA, effectiveness reviews and process audits in order to drive continual improvement in your quality ecosystem.

AssurX CAPA Management Dashboards and Analytics
  • Keep your quality process integrations seamless and efficient. The AssurX Platform ends delays in manual process models. In addition, the AssurX platform simplifies solution integration. As a result, it’s easy to connect other processes for document management, training management, CAPA, supplier quality management and audit management.

  • AssurX makes it easier for your teams to participate in compliance efforts by incorporating regulatory requirements in your system. Our expertise in regulated industries assures that you are best aligned for regulatory and industry compliance. In fact, our customers consistently report zero audit and inspection findings.

  • By increasing visibility, AssurX helps increase awareness where management decisions are needed during investigations. Furthermore, data collected during the deviation management process facilitates insights that can help drive continuous quality improvement.

  • Utilize a risk-based approach to prioritize deviations and nonconformances based on risk criticality levels that meet your quality requirements.

  • AssurX features speed your time to completion. Time-sensitive tasks, tracking tools, dashboards and notifications keep your process moving foward. Add multiple impact assessments based on the type(s) required. Manage equipment nonconformances, testing discrepancies, complaint-triggered findings, production issues, human error, and more – all from one centralized system.

More than 2,100 personnel-hours saved in reporting defects. Previously, reporting consisted of the defect being logged manually (handwritten) and then entered into Excel spreadsheets.


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.

Enterprise System Integration

AssurX delivers flexible and reliable integration with enterprise applications including MOM, SCM, ERP, PLM, and CRM. In addition, we have extensive experience integrating with SAP, Salesforce, Oracle, PTC/Windchill, and leading MES systems.


AssurX offers CSA validation services based on the FDA’s risk-based approach, which dramatically reduces validation time and cost. AssurX’s risk-based validation model provides tailored validation services based on a critical thinking approach that supports the GAMP 5 Model.

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.

Audit Management

CAPA Management

Calibration Management

Change Management

Complaint Management

Customer Quality Management

Deviation Management

Document Management

EHS Incident Management

Nonconformance Management

Quality Management Review

Risk Management

Supplier Quality Management

Training Management

Validation Management Solution