CAPA (Corrective Actions & Preventive Actions)
Maintain Regulatory Compliance Through Integrated Corrective Action Preventive Action with LIMS
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 actions 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. 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.
Increased Compliance Through LIMS with Integrated CAPA
Realizing those challenges, LABVANTAGE CAPA was developed to help customers 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. LABVANTAGE CAPA is completely integrated with the extensive capabilities of the LABVANTAGE LIMS platform, in order to enable enterprises to monitor, record, investigate, and quickly react to both planned and unplanned incidents, deviations, and other non-conformities occurring in their processes.
LABVANTAGE CAPA provides the ability to identify, investigate, disposition, and report incidents occurring throughout laboratory operations. Within LABVANTAGE CAPA, 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. 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.
Accelerate Safe Product Release Through Expedited Issue Remediation
LABVANTAGE CAPA helps companies identify hazards early, determine errors, and mitigate problems by managing and executing corrective actions or investigation plans to help minimize potential loss. The solution facilitates the execution of actions with complex tasks and approvals, aids in discovery of the root causes of an incident, and assists in developing preventive actions to prevent recurrence. LABVANTAGE CAPA provides real-time visibility into the all laboratory and business operations, creating a responsive laboratory environment that facilitates and accelerates the delivery of quality products.
- Record and manage both planned and unplanned incidents
- Record findings and results of an investigation for determination of action plans
- Define action plans in accordance with an incident or investigation finding
- Create work orders to track the completion progress of action plans
- Record and track ad hoc incidents
- Define triggers that automatically create incidents when a violation is detected
†An 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.