Interface software CONFORMITY

editingaccess controlmedical

CONFORMITY administration interface in medical technology Validated 100% inspection Full documentation CONFORMITY: Administration interface for the demands of 21 CFR Part II FDA The CONFORMITY software provides and access and administration interface for the SAPHIR measurement and analysis software from Dr. Heinrich Schneider Messtechnik GmbH that guarantees compliance with the high quality-relevant demands on a software system in the manufacturing industry. GMP-relevant factors in the functional area Access control: A controlled access management system provides protection from unauthorised users. The use of a user name plus password ensures clear identification of the operator; the settings for password and user name can be configured by the system owner above the security level defined by the manufacturer. Updating of relevant data sets, measurement programmes and system files in order to be able to trace the history at all times. Definition of procedures and their sequence (controlled workflows) to satisfy quality assurance processes. Audit trail: In line with the demands on quality management and quality assurance, all quality-relevant operations on data sets (creating, editing and deleting of data) are automatically recorded with time stamp and operator and documented separately in an audit trail. Editing and deleting of electronic data does not generally overwrite the current data sets; a new version of the data set is created and the previous versions remain available. Released measurement programmes can only be used by authorised employees – this is ensured by CONFORMITY.