Effectively managed CAPAs can benefit a company in its quest to remain compliant. However, they can also be made overly complex, be allowed to remain open for too long, or be too complex for staff to understand. We look at how a robust and compliant CAPA system can benefit a company and we provide useful tips on ensuring that your CAPA system performs for your company.
Are you effectively managing your CAPAs?
Pharma biotech companies around the globe are struggling to juggle numerous priorities and challenges. One of their biggest struggles is to effectively manage CAPAs.
Let’s begin by using this 5-step checklist:
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Do you use a scored risk assessment process to determine the need for an investigation and CAPA?
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Do fewer than 10 percent of your investigations conclude human error as the root cause?
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Do you maintain and use metrics on how your CAPA system is performing?
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Do you perform effectiveness checks that include objective and measurable criteria?
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Do fewer than 25 percent of your CAPAs need extensions?
Unless you answered YES to all the questions, your CAPA system may not be as robust and compliant as you think.
