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What is the Butterworth Laboratories stance with regards to computer compliance and, in particular, 21CFR Pt11?

April 26, 2017butterworth compliance Computer laboratories particular regards stance

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What is the Butterworth Laboratories stance with regards to computer compliance and, in particular, 21CFR Pt11?

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We have a commitment to attaining the highest level of computerised system validation and compliance to quality regulations. As part of this commitment, each new analytical system is specifically selected to meet current and predicted future requirements. Existing systems have been assessed using a GAP analysis, which identified areas for improvement. These areas are being actively addressed.