Manage Manufacturing Deviations and Investigations with Precision


Home|Manufacturing Deviations and Investigations Software

AssurX Manufacturing Deviation and Investigation Management software solution helps enterprises streamline and automate the tracking, documenting, and resolution of manufacturing-related quality incidents, such as nonconformances, OOS, defects, failures, and exceptions.

Deviations management software from AssurX efficiently automates the processing of quality issues from detection through investigation, disposition, corrective actions, and change control in a single system.

With AssurX management software, you can ensure quality issues from any source are logged, and root causes are investigated across operations. Even into the supply chain, corrective actions and dynamic changes are automatically launched, documented, and implemented.

Regardless of where an issue originates or how many departments it touches, the AssurX system lets you control the process with efficiency and consistency.

Benefits of Using AssurX Manufacturing Deviations and Investigation Management Software

Foster Risk-Based Thinking

Align with ISO 9001 risk-based thinking by making it part of your nonconformance quality management process. Proactively focus on using risk to make better decisions instead of approaching risk as a siloed activity. Activate risk assessment tools such as FMEA, decision tree, and 5 Whys.

A Fully Integrated Platform

Conduct manufacturing nonconformance investigations and link to powerful CAPA management and change control solutions. A centralized platform makes every investigative action transparent and trackable throughout the quality chain.

A Proactive Approach

Automated nonconformance management accelerates the efficiency for controlling incidents, implementing corrective measures, helping avoid their recurrence, and for taking a proactive approach to continuous quality improvement.

The AssurX Manufacturing Deviations and Investigations Management solution logs any quality incident and efficiently manages its evaluation, investigation, corrective action, and required systematic changes.

Highline Warren, a $1B manufacturer with over 24,000 products is leveraging powerful processes to build a quality management system to increase accountability, generate meaningful data, and drive continuous improvement.

AssurX: Connected Quality and Validated Compliance


Capture all relevant data within a single repository. Use powerful analytics, trending, and reporting features to deliver insights into the entire quality management process.


Automatically link processes, issues, actions, and information throughout your operations. The result is a truly holistic approach to quality management that is more effective and efficient.


With AssurX software’s built-in compliance features, you can be assured your operations will stay in line with FDA, ISO, GxP, EMEA, HACCP, and others.


Increase yields and reduce time to market with consistent, efficient issue management.


Facilitate continuous improvement, reduce problems, and prevent recurring issues by consistently addressing root causes.


The software integrates seamlessly with other systems like ERP, PLM, CRM, LIMS, and MES to connect all manufacturing and quality-related processes.

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.

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