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© 2023 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
May 01, 2003
On 20 February 2003, the US Food and Drug Administration (FDA) published a new draft guidance relating to 21 CFR Part 11. The new guidance mainly affects the compliance requirements of systems with a low risk and low impact on product quality; however, systems with a high risk and high impact on product quality, such as chromatography data systems or laboratory information management systems (LIMS), remain unaffected, as this article describes.