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
- Reduced Disruptions
- Decreased Product Quality Costs
- Improved Consistency and Quality
- Optimized Quality Control and NonConformance Management
- Increased Enterprise Collaboration
- Rapid Deployment
- Decreased Regulatory Risk
- Ready to Validate
- Configurable workflows that enable the creation of many types of processes, including OOS ,
deviations, incidents, and nonconformance processes. - Extensible configuration of reactive events directly from configurable templates
- Easy development, without programming knowledge, of a configurable form for
each step of the NC workflow with granular field-level security - Capability to set auto triggers to start a corrective action workflow.
- Capability to view parent-child relationships.
- Large existing field library to build forms or capability to add your own fields.
- Compliance with 21 CFR Part 11
- Configurable drop-down lists
- Integration with all eQCM modules
- Advanced analysis and reporting
Report. Analyze. Monitor.
The eQCM Compliance Intelligence module empowers users to make more informed decisions by providing timely, relevant, and accurate answers to their business questions. The eQCM® Compliance Intelligence offers easy-to-configure dashboards and reports to facilitate compliance monitoring and reporting against all key compliance performance indicators (+)
