CAPA investigates, understands and corrects deviations and nonconformities, addressing the immediate impact and minimizing recurrence, with plans scoped and deepened in proportion to what is at risk for patients, product quality and the integrity of data; incidents related to GxP configuration items are reported as deviations and investigated for impact, and CAPAs are created from the investigation. The process covers assessment of impact, planning corrective action that deals with the impact, including isolating the issue, invoking recovery or restoration and reinstating services, root cause analysis by relevant experts, preventive action to minimize recurrence through enhancements, fixes, training, procedure updates, security or monitoring, monitoring of completion against targets with reminders and escalation, extensions reviewed and approved by the process and system owners under quality unit oversight and CAPA status reviewed in periodic reviews and audits, effectiveness checks confirming the root cause is addressed, and trending at organizational, process or system level with learning fed into system risk assessments. CAPAs are usually managed in an electronic quality system, actions are assigned to appropriate experts including IT and engineering and are proportionate to risk, the quality unit establishes and oversees the process, process and system owners review, approve and monitor CAPAs for their systems, and plans are approved by process owners, system owners and action owners.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.