GLP in Clarity

This section describes how Clarity supports compliance with GLP requirements.

Some measures are mandatory for operating Clarity in a regulated environment, while others depend on specific system configurations or company policies.

Each requirement listed below includes a reference to the relevant section or SOP that provides further guidance and setup details.

Mandatory

• The computer on which Clarity is installed must operate under conditions where every user has their own defined rights - see the chapter "Computer User Rights".
• File overwriting in Clarity must be disabled. Data loss caused by overwriting or similar actions must not be allowed - see the chapter "Computer User Rights".
• Every user who has access to Clarity must have their own user account with unique password and defined access rights specifying which actions they can perform - see the chapter "User Accounts in Clarity".
• Every change in the data must be properly logged - see the chapter "Logging of all changes".
• The reason for each change must be logged, along with the change itself, so that it can be reviewed later - see the chapter "Logging reasons of changes".
• All data must be archived for the period specified by relevant authorities - see the chapter "Archiving the data".

Optional

• When Quality Control or Quality Assessment personnel are present – QA staff should have their own access to the Clarity station, without authorization to modify any data - see the chapter "SOP - User Accounts - QA account setup".
• When user calculations are used, all users must have the same settings in the user calculation columns - see the chapter "Shared desktop file".
• Multistation environment: each user must have an individual account but use the same credentials and access rights on every Clarity station - see the chapter "Multistation environment".