In the U.S., pharmaceutical firms must meet electronic record-keeping regulations set by the Food and Drug Administration (FDA). The regulation is Title 21 CFR Part 11, commonly known as Part 11.
Part 11 requires regulated firms to implement controls for software and systems involved in processing many forms of data as part of business operations and product development.
Enterprise data warehouses are used by the pharmaceutical and medical device industries for storing data covered by Part 11. QuerySurge, the only test tool designed specifically for automating the testing of data warehouses and the ETL process, is the market leader in testing data warehouses used by Part 11-governed companies.
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