System Sustainability

Abstract:Changing any significant component of a system commonly necessitates changes to the organizational culture. This is illustrated for a pharmaceutical facility, where production changes to improve quality required expansive quality system modifications to ensure lasting success and regulatory compliance. The need and benefits of any change must be understood and accepted by all, from top management levels throughout the workforce. A quality unit should be responsible for identifying problems and for proposing and overseeing change, examining all affected subsystems, and focusing on compliance and sustainability without regard to costs. Change must go beyond operational adjustments and training. A culture of compliance is key to supporting and maintaining necessary …

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