Avoiding CAPA Overload During Regulatory Compliance Efforts

May 5, 2022

The path to regulatory compliance is beset with obstacles that can grind down market efforts to a halt. One major stumbling block for many pharma firms is corrective action/preventive action (CAPA) overload. “Death by CAPA” occurs when companies get overrun with investigations into quality events. In a new Master Control blog, James Jardine explains how developing an effective CAPA management system can help avoid regulatory road blocks.

According to Jardine, “Innovative CAPA management system solutions are helping pharma companies overcome these challenges and enabling them to manage CAPA processes more efficiently and effectively. With a formal, risk-based CAPA process reinforced by purpose-built quality management software, pharma companies can establish what McKinsey & Company life sciences experts are calling a “smart quality” approach. This modern, smarter approach is resulting in dramatic improvements to quality assurance processes in real-world use cases.”

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(Source: Master Control, April 14th, 2022)

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