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CombiStats contains several features supporting that support its use in a quality-controlled environment: the different protection levels of the calculation sheets, several options for printing the meta-data metadata (e.g. path name, file size) and the unique file identification (hash code) in footnotes. CombiStats offers the required technical control of a compliant system, which, in addition to administrative controls to be put in place by the user, can satisfy the Title 21 CFR Part 11 requirements. More details can be found in the user manual, section 9 (pp. 65-69)For more information, see section 9 of the CombiStats User Manual.