Compliance with FDA 21 CFR Part 11

Users are managed on the basis of groups, with each user being recognized by means of a username and password. Unique groups can be created by including persons having different access privileges. Clearly defining each user’s access privileges prevents unauthorized changes to settings, instrument operation, and data access.

LabSolutions’ user administration comprises the setting of rights groups and assignment of rights to users just as in Windows. Access rights required for each user can be set by assigning various levels of access to each user. This helps achieve effective user administration and more efficient laboratory operations.  

Logins and logouts to the system, changes in users and groups, and the start and completion of acquisition, together with the username and the time, are all recorded. The recorded operational log can be registered in the database to provide traceability.  

The integrity of the programs that comprise the system and the raw data acquired by instruments can be checked, ensuring the reliability of the system and data. The results of these alteration checks can be managed as printouts.