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Learning from mistakes with deviation and capa management

by cyb2025
E. Lowe
auditing
CAPA
Corrective Action Preventive Action
drug development
gcp
GVP
pharma
PHARMACOVIGILANCE

HELEN LOWE
Auditing and Quality Assurance Director, Arriello, Ireland

ABSTRACT

Pharma companies may make mistakes during drug development but if they apply only a temporary solution to the problem, this can just lead to the error being repeated. So how can we work more effectively and ensure we are not repeating the mistakes of the past? Helen Lowe at Arriello outlines a best-practice approach, showing how Corrective Action Preventive Action (CAPA) management provides a structure to uncover the root causes of problems, solve them and build solutions, as well as look for potential problems that might arise in the future. Effectiveness checks then allow for the review of such preventive measures to ensure that what you have put in place works for the long-term benefit of the company.

If a company wants to improve performance and outcomes, it also has to recognise and understand its failures. But this entails more than just making a bit more effort – it needs a change of mindset so that failures cease to be seen as problematic but are instead viewed as an opportunity to correct areas that need improvement.

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