After nearly 20 years helping the biopharmaceutical industry to regulatory enforcement by implementing an operational and sustainable quality management system, I have come to the conclusion—at the most fundamental level—that there are three quintessential elements required for success. I call them the quality management triad.

Quality governance

Quality governance is the first element. This is the body that provides:
• Vision. The aspirational view of the future, and how quality management is integral to the business strategy.
• Leadership. The top business unit and functional heads who motivate, align, plan, and engage the organization toward its quality goals.
• Standards. The policies and standards that are endorsed by leadership that establish the quality requirements.
• Oversight. The communication channels and forums that provide leadership with direct visibility of product quality, and compliance risks and trends, to make effective data-driven decisions.

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