Corrective and Preventive Actions (CAPA)
Corrective Action and Preventive Action (CAPA) management is one of the most daunting tasks of any quality-minded organization. FDA, ISO, EMEA, and other regulations and standards mandate a systematic approach to managing corrective and preventive actions.
While all organizations hope to avoid the root causes that necessitate corrective actions, reality dictates otherwise. Because defects, deviations, or any other gaps that trigger the need for a CAPA can come from a myriad of sources (documents, training, products, etc.), CAPA management has become the core process of a well-established compliance and quality program.
The eQCM CAPA™ module is an integral part of the eQCM quality management suite. It may be used as a stand-alone module in small organizations or integrated with other processes such as nonconformances, audits, training, complaints and others. The eQCM CAPA™ module allows organizations to create a single configurable workflow to handle the entire lifecycle of the CAPA from the triggers that can auto-launch the corrective action to the final sign-off. If your company prefers, multiple workflows can be developed also – without vendor or IT support.
Business Applications
- Corrective Action Management (for all types of sources including documents, products, services, supplier products, equipment, instruments, etc.)
- Preventive Action Management
- Suggestion and Enhancement Requests
- Problem management
- Anomalies management
- Change management
- General Action item tracking
eQCM CAPA™ Value Proposition
- Identifies the current state of the situation and flags bottlenecks (# critical problem)
- Enables problem reporting in a uniform and quick manner
- Categorizes actions and sources in order to generate business intelligence
- Increases follow-up efficiency
- Assists in identifying improvement opportunities
- Controls and reduces recurrence by allowing root cause analysis and verification in the process
- Diminishes number of rejects
- Decreases production costs
- Increases collaboration with appropriate configurable review and approval cycles within the process.
- Increases the satisfaction of your customers
- Capability to create simple or complex CAPA processes with user-defined forms and fields.
- Capability to create your own fields and add them to the field library.
- Configurable report functionality allows the “slicing and dicing” of data for your particular needs.
- Capability to create ad-hoc action plans or choose from a library of action plans.
- Intelligent workflows can adjust responsibles and/or forms depending upon data entry.
- Configurable escalating notifications possible based on multiple types of triggers.
- Possibility to have review and approval of information prior to proceeding to the next step.
- Ability to document root cause analyses.
- Capability to see the source of the CAPA and the related items (documents, products, equipment, etc.)
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 (+)
