Audit Trail and History

The Change Control Suite provides comprehensive tracking of all actions performed within the system, allowing users to review the audit trail of changes, section locks, and unlocks across all modules and sections. This functionality is crucial for maintaining transparency and accountability in the change control process. Below are the key elements of the audit trail and history functionality:

1. Activity Logs (Audit Trail)

In every module of the Change Control Suite, including the main Change Control module, all sections from 1 to 11, and the Task Management module, users can review the complete history of changes made to a record. This includes what was changed, by whom, and when it was done. To view the audit trail for a particular record:

• Open the record in any module or section.
• From the toolbar, click on the Activity icon, which is represented by a clock-shaped icon with a circular arrow around it.
• A detailed history of all changes will be displayed, showing each action along with the corresponding timestamp and user information.

2. Section Lock and Unlock Logs

In specific sections of the Change Control process, the system enforces a locking mechanism to ensure that only authorized users can make further changes. Users can view who locked or unlocked a section and when it occurred through the Section Lock Logs. This is available in the following sections:

• Section 1: When a QA Specialist completes the initial review, they lock the section, and Section 2 is automatically created. The lock/unlock activity is recorded in the Section 1 Lock Logs.
• Section 2: After both managers provide their comments, QA Specialists, QA Managers, and the Quality Director review the change. Any lock or unlock actions for this section are recorded in the Section 2 Lock Logs.
• Section 3: When the QA Director completes the review and locks the section, the system records this activity in the Section 3 Lock Logs. If the "Change Control Committee Review" is required, Section 6 is also created.
• Section 4: The QA Director assesses the need for an effectiveness evaluation and locks the section. This action is captured in the Section 4 Lock Logs.
• Section 6: When the Change Control Committee holds a meeting and approves or rejects the change request, the lock/unlock actions for this section are stored in the Section 6 Lock Logs.

Each log contains details such as the user who locked or unlocked the section and the exact timestamp of the action. This information is easily accessible through the respective submodules for each section.