New audit trail
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Prerequisites
- SoftExpert Suite environment contracted in the Cloud Regulated modality.
- Audit trail configured in the Configuration > Audit trail (CM012) menu.
- Access to the Configuration > Framework > Audit trail (CM003) menu.
Introduction
The new audit trail records the changes committed to the SoftExpert Suite database, regardless of where they originated, according to the audit trail configurations. It was developed to meet strict regulatory requirements, such as the FDA 21 CFR Part 11 standard, which requires a complete, segregated audit trail protected against changes.
This article presents the availability of the new audit trail, its advantages over the current audit trail, the configurations that affect how it works, and how to view the records in the Audit trail (CM003) menu.
Availability
The new audit trail is available exclusively for environments in the Cloud Regulated modality. It was built on a regional, standardized cloud platform and has no version for local installation.
The other environments continue to use the current audit trail:
- environments in the other Cloud modalities
- on-premise environments (installed on the customer's own infrastructure)
The new audit trail is only compatible with the PostgreSQL database. The current audit trail continues to support Microsoft SQL Server, PostgreSQL, and Oracle databases.
Advantages of the new audit trail
The new audit trail changes the way changes are captured and stored. See the main advantages:
| Advantage | Description |
| Complete coverage | Records the changes committed to the database regardless of their source: system screens, integrations, scripts, or changes made directly in the database. |
| Segregated storage | Audit records are stored separately from the system database. Thus, not even users with write access to the database can edit or erase the audit evidence. |
| Protected records | Records cannot be edited after they are saved, and the date and time of each event cannot be manipulated. This ensures the reliability of the trail in audits and regulatory inspections. |
| Grouping by operation | Changes made in the same operation are grouped together. It is not necessary to manually relate isolated records by the time they occurred. |
| Operation context | Each operation performed through the system informs who performed the action, where it was performed, and the reason, when provided. For changes made directly in the database, the user and the reason are not recorded, since this information is provided by the system at the time of the operation. |
| Readable information | Related records are displayed in an understandable way, such as the user name, instead of internal system codes. |
| Lower performance impact | Changes are captured separately from write operations. Therefore, auditing does not overload system use. |
| Report export | Audit records can be exported to PDF and XLSX. |
Configurations that affect the new audit trail
The configurations set in the Configuration > Audit trail (CM012) menu also apply to the new audit trail and define how it handles events. See the main effects:
| Configuration | Effect on the new audit trail |
| Enable audit trail | Defines the level of detail of the recorded events. With the Enable partially option, the trail records only the table in which the change occurred. With the Enable fully option, the trail records the complete transaction, including the changes to the fields. |
| Keep logs during _ day(s) | Defines for how many days the events remain available for viewing. |
Comparison between the audit trails
The table below summarizes the differences between the current audit trail and the new audit trail:
| Characteristic | Current audit trail | New audit trail |
| Modality | Cloud and on-premise. | Cloud Regulated only. |
| Viewing menu | Audit trail (CM002). | Audit trail (CM003). |
| Database | Microsoft SQL Server, PostgreSQL, and Oracle. | PostgreSQL. |
| Recorded operations | Add, edit, delete, view, and confirmation. | Add, edit, and delete. |
| Source of recorded changes | Operations performed through the system. | Any change committed to the database, including those made directly in the database. |
| Storage | In the same database as the system. | Separate from the system database. |
| Organization of records | Each change generates an isolated record. | Changes are grouped by operation. |
| Conformity with FDA 21 CFR Part 11 | Does not fully comply. | Complies. |
The new audit trail does not record view operations. Only operations that change data (add, edit, and delete) are audited.
Viewing the new audit trail
1. Access the Configuration > Framework > Audit trail (CM003) menu.
2. Click on the Filters button and select the filters to be used in the search. Next, see the options available for selection:
Available filters
When clicking on the Filters button, the list of available options is displayed. The most frequently used filters appear in the Most recent group, and the menu search field allows finding a filter by name.
- User: filters the records by the user who performed the operation.
- User type: filters the records by the type of user who performed the operation, such as Internal.
- Date: filters the records by the period in which the operation was performed.
- Object: filters the records by the system record or resource in which the operation was performed.
- Operation: filters the records by operation type (add, edit, or delete).
- IP address: filters the records by the IP address of the device that requested the operation.
- Domain: filters the records by the domain that requested the operation.
- Component: filters the records by the SoftExpert Suite component involved in the operation.
- Reason: filters the records by the reason provided when performing the operation.
3. Enter the values of the selected filters.
4. Click on the Search button to display the audit records.
5. View the information of each operation in the list of records. If necessary, click on the arrow next to the record to view the details of the operation.
By default, the search already presents the User type and Date (last 7 days) filters filled out. Adjust or remove them as needed. To remove all filters at once, click on the Clear filters button.
Record information
Each record in the list presents the information below:
| Information | Description |
| Operation | Type of operation performed (add, edit, or delete). |
| Object | System record or resource in which the operation was performed, such as the item, asset, or input record. |
| Date | Date and time when the operation was performed. |
| Record | Data that identifies the record affected by the operation, such as the ID # and the name. |
| User | User who performed the operation. It is not displayed for changes made directly in the database. |
| Component | SoftExpert Suite component involved in the operation. |
| Reason | Reason provided by the user when performing the operation. When no reason was provided, the Not filled out message is displayed. |
Screen resources
| Resource | Description |
| Save search | Saves the applied filters to reuse them in future searches, without having to fill them out again. |
| Saved searches | Side panel that lists the saved searches. Click on a search to apply the corresponding filters. To edit or delete searches, click on Manage searches. |
| Reports | Exports the audit records resulting from the search to PDF or XLSX. |
Conclusion
Thus, environments in the Cloud Regulated modality have a complete, segregated audit trail protected against changes, whose records are viewed in the Audit trail (CM003) menu. The level of detail and the retention period of the events continue to be defined in the Audit trail (CM012) menu. The other environments continue with the current audit trail, viewed in the Audit trail (CM002) menu.