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Determining Part 11 and Annex 11 Applicability SOP

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Description

This SOP lays out seven individual steps necessary to assess any computerized system to determine if it needs data integrity controls under FDA 21 CFR § 11 or EU cGMP Annex 11. The SOP also includes a form-based decision-tree to be filled out for each system to document the applicability decision and logic. Complies with FDA, EMA (as well as Health Canada and MHRA) expectations. This SOP is ready to be used and requires only a small amount of site-specific modification.