Nonconformance Management

In stringent FDA and ISO environments, materials that do not conform to product quality requirements could lead to costly rework and even product recall. These nonconformities increase the organization’s risk of adverse impacts to business continuity, customer relations, market reputation, or other areas. CGMP, 21 CFR Part 820, ISO standards such as ISO 9001, ISO 13485 and ISO 14001 all require proper disposal of nonconformances. Organizations which pursue continual improvement must address the concerns of nonconformances and develop corrective/preventive actions to prevent the repetition of these occurrences in the future.

The eQCM nonconformance software will enable organizations to manage and automate all steps in a nonconformance process. The management of nonconformances in eQCM provides automated, web-based tools for managing materials, processes, components and products. Whether your organization manages defects, deviations, out-of-spec results or other types of issues, the integrated eQCM nonconformance module can replicate your workflow, recording, recordkeeping, and reporting needs.

Business Applications:

• Nonconformance Management
• Deviations
• Defect management
• Incident Management
• IT incident and problem management
• Out of Spec management
• Exceptions and Issues
• Investigations (including fraud)
• Fraud investigations

eQCM NC Value Proposition: