The CFR 21 part 11 compliance module, available on the ViGIE platform, enables organisations to achieve compliance with that standard.

ViGIE platform provides compliance with the standard through a set of functionalities regarding login and password, user event logging and Audit options.

When the FDA CFR 21 part 11 compliance module is activated, the following requirements and functionalities are added to the platform.

Login and password:

• Increased complexity in passwords, forcing them to contain at least 8 characters, including 1 uppercase letter, 1 lowercase letter, 1 number and 1 symbol.

• Password reutilisation policy, preventing users from reusing the last 3 passwords.

• Possibility to define the validity of the password (in number of days), forcing users to change the password according to the defined periodicity.

• Possibility of blocking a user's access to the platform.

User event logging:

• Register of changes made by users of the platform, namely the addition, deletion or change of a user and/or their permissions.

• Register of events carried out by each user such as login, logout and password changes.

• Need for user validation when the user makes changes in the system configurations.

Audit Options:

• History of all changes made to the system.

All these functionalities allow compliance with the FDA CFR 21 part 11 standard, facilitating the control of accesses and changes made to the platform and providing an increase in the system's security.

Find out how to activate the FDA CFR 21 part 11 compliance module by checking the link below.

How to enable the CFR 21 part 11 compliance module?