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Elements of CAPA
November 1, 2004
1 Min Read
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Originally Published MX November/December 2004
INFORMATION TECHNOLOGIES
To help ensure product quality and traceability, EMS providers must find ways to integrate their corrective and preventive action (CAPA) systems with similar systems used by their OEM customers. Each EMS factory should have a process for identifying and fixing problems. Following are key steps involved in operating an FDA-compliant CAPA system, as recommended by industry association AdvaMed (Washington, DC).
Investigate the cause.
Report to FDA if required.
Correct the problem (corrective action) and prevent recurrence(preventive action).
Check effectiveness of corrective action.
Approve and implement preventive action.
Monitor long-term (as necessary).
The annual meeting of the Regulatory Affairs Professionals Society (RAPS) is a good place to find out about FDA's current thinking and where the agency is going with issues facing industry. The meeting takes place every October, typically in Washington, DC, or in Baltimore, MD. For additional information about RAPS, visit the association's Web site at www.raps.org.
Copyright ©2004 MX
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