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| home > epc > summer 2003 > the impact of the new 21 cfr part 11 guidance on data systems and networks in gxp environments |
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European Pharmaceutical Contractor
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| In February 2003, the FDA published a new draft guidance on 21 CFR Part 11 that reduces compliance efforts on systems with low risk for product quality (1). Part 11 remains in effect for systems used for regulated activities with a high risk impact on product quality, such as chromatography data systems (CDS) or laboratory information management systems (LIMS). Background information on 21 CFR Part 11, the rule for electronic records and signatures, and its impact on the GxP regulated environment was discussed in the Spring 2003 issue of EPC (2, 3). Since then, the FDA has announced the re-examination of Part 11 (1). In the light of a new cGMP initiative launched in August 2002 (4), FDA published a new draft guidance and withdrew previous guidance documents (5-10). Neither Part 11 nor the previous guidance differentiated between systems with high risk on product quality and safety like chromatographic data systems used for QC analysis of final drugs, and low risk systems like word processors used to generate an SOP. The Gap between Original Intent (1997) and Reality (2003) Part 11 was originally intended to protect public health while enabling the use of new technology. Since Part 11 itself only defines the framework, it was difficult for the industry to find the correct balance between doing just enough and doing too much (11). In some cases, companies decided against the use of new technologies and kept paper-based systems just to avoid Part 11. |
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