GLP – requirements
Some of these requirements are mandatory in order to comply with the GLP, others are required only when some special features in Clarity or special conditions in the company should be satisfied. The steps in the following list are divided into mandatory and optional. Each requirement then links to a corresponding section in the next chapter that includes the general guide for solving the requirement and particular SOP.
Mandatory
- The computer in which Clarity is installed must operate under the 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 this or any similar reason can not be allowed - see Note section in the chapter "Computer User Rights"
- Every user who has access to Clarity must have their own user account with his/her own secret password and access rights defining which actions he/she 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 the change must be logged, along with the change itself, so that the reason for the change can be found later - see the chapter "Logging reasons of changes"
- All data must be archived for the period specified by appropriate authorities - see the chapter "Archiving the data"
Caution:
In order to maintain good Data Integrity the staff who runs Clarity (typically laboratory staff) mustn't have any privileges to change Windows System Time on the computer where Clarity is operated. If this condition is not fulfilled it can easily jeopardize correctness and integrity of the timestamps in Audit Trail because they are recorded as current Windows System Time in the moment of any action performed.
Optional
- When Quality Control/Quality Assessment workers are present – Quality Assurance Personnel should have their own access to the Clarity station, without the authorization to change any data - see the chapter "SOP - User Accounts - setup QA account"
- 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 – when the user (or several users) is supposed to work on several computers, the user accounts for all users (along with stored passwords) should be the same for all users everywhere - see the chapter "Multistation environment"