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Medical Devices / QSR

UL White Paper Outlines Steps to Ensure Data Integrity Compliance

Sept. 30, 2016
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Underwriters Laboratories released a white paper as a guide to ensuring that every computerized data system complies with FDA regulations and international standards.

Data integrity, involving the recording, collection, reporting and protection of traceable information, is essential for offering proof to the FDA and other investigators that a company is abiding by good manufacturing practices. In addition to proving that the information is organized and specific, it must also accurate, and the system must be secure.

The paper states that the goal is for the FDA to know how organizations obtained and recorded their data and that companies should use a system known as ALCOA, meaning the data should be attributable, legible, contemporaneous, original, and accurate.

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