The Rise of Data Integrity Audits: Are You Ready?

Data integrity is no longer just a compliance checkbox—it’s a top priority for regulators worldwide. The FDA, EMA, MHRA, and WHO have ramped up enforcement, issuing a growing number of 483s and warning letters for failures in data governance.

📌 Why the Surge in Scrutiny?🔹 Increased reliance on electronic records and automation🔹 Risk of data falsification, deletion, or manipulation🔹 Greater outsourcing to CMOs/CDMOs with varying compliance standards

🚨 Are You at Risk?If your data integrity controls are weak, your organization could face:✅ Regulatory sanctions✅ Product recalls✅ Costly remediation efforts✅ Loss of market trust

🔍 Key Areas to Strengthen for Audit Readiness:✔️ Robust ALCOA+ principles: Ensure data is Attributable, Legible, Contemporaneous, Original, and Accurate (+Complete, Consistent, Enduring, Available)✔️ Audit trails: Track every action in your electronic systems✔️ Access controls: Prevent unauthorized edits to critical data✔️ Training: Equip employees with data integrity best practices✔️ Vendor oversight: Hold CMOs/CDMOs accountable for compliance

With regulators setting the bar higher than ever, companies that fail to prioritize data integrity are exposing themselves to major risks. Is your company audit-ready?

Let’s discuss—what are your biggest challenges in maintaining data integrity compliance? 👇

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