How A Regulator Observe Data Integrity Of Pharmaceutical Industry Essay

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How a regulator observe Data Integrity in Pharmaceutical Industry Regulatory authorities across the Globe have imparted a lot of learning to the organizations. The Objective of regulatory investigators is to provide assurance of acceptable product quality, purity, safety, identity and effectiveness for intended application by, assessing cGMP ensuring data accuracy and reliability of results. Regulators have always corrected organizations through standardized security control to adhere cGMP requirements and regulations. Regulatory authorities expect the use of compliant instruments/equipment, with security functions for traceability and accountability of operations. Finally, regulators have helped in Strengthening quality standards, Generating high level of assurance/trust in the products as well as the organization. How regulators visualize Data Integrity? Have a look at the following points. • If it’s not written down, It never Happened • In God we trust, all others bring data • Quality means: Doing right When no one is Looking (Henry Ford) • Integrity is telling myself the truth, Honesty is Telling the truth to other People (Spencer Johnso) Let us review some fundamentals about Data Integrity. What is “data integrity”? Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate (ALCOA). This refers to maintaining

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