CONFORMITY Description
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.
Traceability of the measurement results in combination with the use of the releases of the measuring programmes. It records which employee performed the measurements as well as when and with which release.
An approval procedure for relevant routines requires a signature of a responsible person which confirms the effectiveness.
In CONFORMITY, the user is authorised to call up the SAPHIR measurement and analysis software with his specific access rights, and the measurement programmes to be used are managed and updated here.
