Data integrity – maintaining and assuring the accuracy and consistency of data over its entire life-cycle – is critically important in the biopharma industry. First and foremost, public health must be protected. Breaches in data integrity can also interrupt product supply, depriving patients of needed treatments and posing a threat to business.
Unlike many other industries, pharmaceutical quality issues are difficult to detect, and often cannot be visually identified, increasing dependence on product data. False data on product identity, quality, purity or potency – entered accidentally or maliciously – has serious implications. This may cause patient injury, drug shortages, damage to corporate reputation, lost profits, and both civil and criminal liability. More challenging to quantify is the impact of lost trust in a company among customers, patients and regulators. This can be difficult if not impossible to rebuild.