It is necessary to identify which categories contain critical data for GMP, and consequently they must include the feature- Strong electronic signature (ref. Ref. 21 CFR Part 11 pts 11:50, 11.70 and 11.200 / EU GMP Annex 11 p.to 14) and the Audit Trail registration (Ref. 21 CFR Part 11 p.to 11.10e / EU GMP Annex 11 p.to 9).
Once identified these categories, it will be activated the corresponding flag in the “Configuration Documents tab, as shown below:
ELECTRONIC SIGNATURE
Managing documents belonging to the GMP categories, it will, as mentioned, the strong electronic signature. This means that the button is pressed for the signing of a document, the user will be offered a form for insert the user name and password.
AUDIT TRAIL
Each creating, signing, publishing, reviewing and eliminating operation made on a category GMP will be recorded on the Audit Trail, which consists of a database table can not be modified by the user interface and equipped with tools for the detection of any data modification contained (integrity check).
The Audit Trail of a document is viewable through a special button in the toolbar.
In addition to the reconstruction of the history of operations performed on a document, the Audit Trail allows viewing the status of the document at the time of the operation, being able to display the data and the file version.
The “column Integrity ” will bring a red icon If the data have been edited using external tools to QualiWare.
NOTE In a GMP category is not available the opening, the cancellation of a publication and a review as a superuser.
Access management to the categories GMP
In accordance with 21 CFR Part 11 p.to 11.10g / EU GMP Annex 11 p.to 12 you must define the appropriate access to GMP categories,
partly to bring compliant the process of permissions’s assignment has been developed a special form (downloadable from the forum) by which “the managers of the processes users” may require to the System Adminiatrators to enable other users to a specific category, as well as the creation or disabling users. The same System Administrators may, from the form, do this, (if they will approve the request).
The assisgnment may also be made by the traditional way using ” the Users and permissions form”.
The following operations:
– Creating a new user
– a user’s deletion
– Disabling a user
– Modify the flag “Administrator” and “trust” of a user
– Changing a user’s login
– Changing a user business organizations
– Change with the assignment on a recording
– Change of the assignment on a documentary category
will be recorded in the Audit Trail.
To view the log of the changes made you can use the link “Audit Trail”, you see in the following forms of the web version:
– “Users and permissions”, tab “Users Defining”
– “Users and permissions”, tab “Assignment of the permissions ”
– “Setting Document Management”, next to the button “Permissions defining”
Auxiliary operating for the user
To ensure the correct excecution of the information flow related document, QualiWare provide some additional controls:
a) enabling a special flag of the class configuration, you can force the opening in reading of the file before signing.
b) enabling a special flag in the administration console, you will be advised if the published document is consulting it at the time under review .
Read for more information also the following articles:
QualiWare configuration for use in accordance with GAMP guidelines