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Compliance with FDA 21 CFR Part 11

LabSolutions PPSQ software provides compliance with FDA 21 CFR Part 11 guidelines and enables
™
compliance with the security, user management, and audit trail requirements speci ed by FDA 21
CFR Part 11.

1 Security 2 User Management
Users are managed on the basis of groups, with each user being recognized by LabSolutions’ user administration comprises the setting of rights groups and
means of a username and password. Unique groups can be created by assignment of rights to users just as in Windows. Access rights required for
including persons having different access privileges. Clearly de ning each each user can be set by assigning various levels of access to each user. This
user’s access privileges prevents unauthorized changes to settings, instrument helps achieve effective user administration and more ef cient laboratory
operation, and data access. operations.

3 Audit Trail 4 Software Validation
Logins and logouts to the system, changes in users and groups, and the start The integrity of the programs that comprise the system and the raw data
and completion of acquisition, together with the username and the time, are acquired by instruments can be checked, ensuring the reliability of the system
all recorded. The recorded operational log can be registered in the database to and data.
provide traceability. The results of these alteration checks can be managed as printouts.

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