The Role of Empower Chromatography Data System in Assisting with Electronic Records Regulation Compliance

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Heather Longden
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White Papers

Regulated pharmaceutical and biotech laboratories are currently striving to meet compliance with 21 CFR Part 11, the U.S. Food and Drug Administration's (FDA) rule governing electronic records and electronic signatures.

Meeting Part 11 compliance remains challenging; however, e-record regulations will eventually be viewed as a significant driver to move companies from a paper-records environment to a more efficient electronic-records environment. Although it is understood that merely purchasing a chromatography data software package that incorporates Part 11 technical controls does not make one fully compliant, technical controls should be inherent in any system used in a regulated environment. A suite of technical controls for 21 CFR Part 11 compliance are built into Empower 3 Software to simplify administration and allow laboratories to meet the U.S. and European regulations.

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