An important part of conducting audits is the review of audit observations and Corrective Actions and Preventive Actions (CAPA)
For an organization’s ethics and compliance initiatives to be truly successful, uncovering and resolving the root causes of compliance issues is critically important. Organizations need to ensure that they have a system that focuses on prevention, quality, root cause analysis and governance which is central to an effective, closed-loop, continuous improvement process.
ClinAudits can help review CAPA and formulate, with our clients, a remediation plan that manages follow-up tasks as a result of investigative outcomes. Remediation and preventative tactics can be created, assigned and tracked to prevent similar incidents from reoccurring in the future. Responsive tactics can also be correlated to specific involved parties to track remedial action such as coaching, termination, training or other activities.
A key requirement of planning for efficient and effective CAPA is that compliance leaders have actionable information – essential to uncovering the causes of incidents and issues – and a way to actively measure their CAPA efforts, analyze resolution and outcomes, and get greater visibility of the progress of remediation activities along with systems development. It is important to provide insight so the enterprise can be apprised and remain vigilant.