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| CAPA |
| Corrective Action Preventive Action |
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According to International Standards Organization (ISO; Geneva) 8402, a corrective action is one undertaken to eliminate the causes of an existing non-conformity, defect or other undesirable situation in order to prevent recurrence. A preventive action, again as per ISO 8402, is an action undertaken to eliminate the cause of a potential non-conformity, defect or other undesirable situation in order to prevent its occurrence.
Corrective and preventive actions (CAPA), the regulatory mainstays for multiple industries, are developed to investigate and correct incidents and nonconformities throughout operational processes in order to remediate problems and prevent recurrence. A complete CAPA solution helps maintain compliance with internal standards and government regulations, including FDA, ICH, and ISO guidelines, to enhance the quality and safety of products and improve operational efficiency in a cost-effective manner. As laboratories in regulated environments are confronted with hurdles to maintain quality control and assurance, they seek to automate their manual CAPA process or update their legacy CAPA systems.
Traditionally, CAPA systems are stand-alone solutions, lacking the capability of integrating quality assurance/quality control (QA/QC) into laboratory processes, and they are isolated from other business processes of the enterprise. Without the capability of investigating laboratory processes, companies lack the ability to determine the actual root causes of incidents, responding with superficial preventive actions. Realizing those challenges, enterprises are searching for a CAPA system integrated with their laboratories and the enterprise, to monitor, record, investigate, and react to both planned and unplanned incidents¹, deviations, and other non-conformities.
The CAPA Module, developed for the SAPPHIRE Laboratory Information Management Suite (LIMS), provides complete functionality to ensure the process of identifying, investigating, dispositioning, and reporting incidents occurring throughout laboratory operations. Within SAPPHIRE, both planned and unplanned incidents are automatically recorded, and investigation steps can be created to conduct further research. Based on the research findings, action plans can be defined to carry out a sequence of tasks to perform root cause analysis and risk mitigation. For action plans with specific tasks requiring work-orders, optional approval steps or types can be added to fully track the completion status of each individual task.
SAPPHIRE helps companies identify a hazard early, determine errors, and mitigate problems, by managing and executing corrective actions or investigation plans, in order to minimize the potential loss. Moreover, the solution ensures the execution of actions with complex tasks and approvals, facilitating discovery of true root causes of an incident, and assisting in developing preventive actions to prevent its recurrence. SAPPHIRE provides real-time visibility into the entire laboratory and business operations, constructing a responsive laboratory environment to facilitate and accelerate the delivery of quality products.
Through SAPPHIRE Enterprise Connector, SAPPHIRE has achieved Powered by SAP Netweaver status and can be seamlessly integrated with SAP ERP. This integration enables SAPPHIRE's CAPA Module to be implemented at various stages of the quality/materials control process within SAP ERP. SAPPHIRE's CAPA Module enables businesses to have a broad overview on their entire business and laboratory operations and promptly respond to unpredicted issues in a cohesive operation environment.
¹An incident is an event that is not part of the standard operation of a service, such as a project, experiment, or test, and may affect the quality of that service. |
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