Nonconformance Management

The Nonconformance Management Software supports life science organizations in streamlining quality event management, specifically focusing on nonconformances. It offers a comprehensive document template package that aligns with life science requirements, allowing documents to be linked to relevant regulatory chapters and setting up workflows with clear responsibilities and reminders.

This module integrates seamlessly within a full quality management system that includes essential modules like training, CAPA, supplier management, audit, and document control. With this software, users can effortlessly identify, analyze, and oversee nonconformances. The software facilitates document creation and management through preconfigured workflows and allows nonconformance escalation to CAPA with ease. It provides visibility into document details such as department, issue handlers, and key deadlines through its metadata card feature.

Tasks and periodic evaluations can be scheduled to check the effectiveness of corrective actions, supplemented by automatic reminders before due dates. The software's monitoring capabilities allow users to track nonconformances by product, process, or supplier, offering customizable views and a detailed audit trail for all actions and document changes.

To maintain compliance with life science regulations, all documents reside in a centralized cloud-based system, searchable by title or content. It supports compliance with post-market surveillance requirements, including necessary reporting to authorities, and allows for electronic signing compliant with FDA 21 CFR Part 11 and EU Annex 11.

The solution integrates all customer management and quality processes into one unified system, utilizing closed-loop workflows to manage nonconformities across modules such as CAPA and change control. Nonconformance escalations can easily trigger CAPA processes and subsequent document updates, with automatic training notifications dispatched when needed. Additionally, this software can be integrated with existing systems like CRM, ERP, LMS, MES, and PLM to ensure a comprehensive product lifecycle management.