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 ICH Q10 Pharmaceutical Quality System

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.

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.

• 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.