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BSI_CAPA_WhitePaper_9. 23. 13 CAPA data must be easy to access and analyze, while having a continuous feedback loop Automating forms-based processes like CAPA, facilitates compliance and saves companies’ time and resources; with automation, the concerns of regulators, auditors, and other stakeholders may be easily addressed
DEVELOPING AND IMPLEMENTING CORRECTIVE AND PREVENTIVE ACTION . . . Introduction The purpose of this educational tool is to establish a standardized process for identifying, documenting, and addressing deviations, noncompliance, and unexpected events in research through Corrective and Preventive Action (CAPA) plans
Incident and Corrective Action Report - Yale University Describe planned changes to reduce the likelihood of a similar incident in the future, and or mitigate its impact, and or speed response In order of preference, risks should be managed by: eliminating the hazard; substituting a safer material or process; engineering controls (e g , ventilation); administrative controls (e g , SOPs, rules, training); or the use of personal protective equipment
Microsoft PowerPoint - CorrectiveandPreventiveActions24Feb04 Subpart J – CAPA cont (1) “Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product” “identify existing and potential causes of nonconforming product, or other quality problems” ”statistical methodology shall be employed to detect recurring quality
CAPA Best Practices: - Boston University Medical Campus When do we need a CAPA? Depth of CAPA investigation and implementation should match the risk Is the quality of the data and or the safety of subjects potentially adversely impacted?
Corrective And Preventive Action Plan (CAPA) Guidance Corrective And Preventive Action Plan (CAPA) Guidance While conducting research, even the most experienced and diligent research teams may deviate from the approved protocol or experience unexpected events Research teams must identify, evaluate, and respond to these deviations and unexpected events to protect the rights, safety, and welfare of participants and others and the integrity of the