Let us help assess and improve your current CAPA process and procedures
ELIQUENT Life Sciences (formerly Oriel STAT A MATRIX) consultants can conduct an independent review of your corrective and preventive action system that will uncover the areas in need of improvement. We can help you create and implement an action plan based on this assessment to ensure that your CAPA system is effective and efficient. We’ve been training and advising medical device companies on CAPA for decades, so we know how to apply best practices to your organization.
Ensuring you meet ISO and FDA CAPA quality requirements
Effective CAPA procedures can improve operational efficiency and product quality. As experienced medical device QA/RA consultants, we understand that maintaining regulatory compliance is also a key focus of CAPA. With this in mind, we can help you:
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Comply with ISO 13485 requirements (sections 8.5.2 and 8.5.3) and all applicable regulations (such as 21 CFR Part 820 and the EU MDR/IVDR).
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Reassure regulatory agencies that your company is capable of identifying and resolving issues.
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Generate objective evidence for regulators that your organization has corrected problems.
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Identify quality problems early in the cycle, before they lead to major nonconformities or compliance violations (such as a FDA 483 observation).
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Bring you back into compliance if a regulator or Notified Body audit leads to major findings.
Our team can conduct CAPA investigations for you
Many firms lack the time, resources, or internal skill sets to conduct effective CAPA investigations. ELIQUENT's experts can plan and complete your CAPA investigations, so that your company obtains the results it needs to understand the root cause of a problem, take the needed corrective action(s), and ensure actions are effective with appropriate statistical methodologies. We will ensure that updated processes are validated and that all personnel impacted by those processes will be properly trained to maintain the improvements.
Contact us today to learn how we can help you improve your medical device CAPA process.