Rule: At Least One Enabled Trail Presence Requirement
This rule ensures the presence of at least one enabled trail in a specific region.
| Rule | At least one enabled trail should be present in a region |
| Framework | GxP 21 CFR Part 11 |
| Severity | ✔ Low |
Rule Details
Description
As per the GxP 21 CFR Part 11 compliance, at least one enabled trail should be present in a region. This regulation ensures that a comprehensive audit trail is maintained for regulated activities in the specified region.
Purpose
The purpose of this rule is to adhere to the regulatory requirements specified in GxP 21 CFR Part 11, which focuses on electronic records and signatures in the pharmaceutical, biotechnology, and medical device industries. By having at least one enabled trail in a region, organizations can maintain transparent and accountable records of their activities, ensuring compliance and data integrity.
Scope
This rule applies to all organizations operating within the jurisdiction of GxP 21 CFR Part 11 and engaging in regulated activities in a specific region.
Target Audience
The target audience for this rule includes compliance officers, IT administrators, and any individuals responsible for maintaining and ensuring regulatory compliance within an organization.
Troubleshooting Steps (if applicable)
If the organization receives a non-compliance notification related to the absence of an enabled trail in a specific region, the following troubleshooting steps should be followed:
- 1.
Validate the Regional Settings: Ensure that the region in question is correctly configured and aligned with the relevant GxP 21 CFR Part 11 requirements.
- 2.
Check Trail Configuration: Verify if there are any configured audit trails in the specified region. If not, proceed to create one.
- 3.
Evaluate Enabled Status: Confirm if the audit trail in the region is enabled. If it is not, enable it to meet the compliance requirement.
- 4.
Review Permissions and Access Controls: Double-check the permissions and access controls to ensure that authorized personnel have the necessary privileges to enable and maintain audit trails.
- 5.
Document Remediation Steps: Throughout the troubleshooting process, document each step taken to resolve the compliance issue. This documentation will serve as proof of corrective action if required by external auditors.
Necessary Codes (if applicable)
There are no specific codes required for this rule. However, depending on the system or software being used, specific commands or configurations may be necessary to enable audit trails in a given region.
Step-by-Step Guide for Compliance
To ensure compliance with the rule of having at least one enabled trail in a region for GxP 21 CFR Part 11, follow these steps:
- 1.
Identify the Region: Determine the specific region where the compliance violation occurred or might potentially occur.
- 2.
Verify Current Audit Trails: Check if there are any existing audit trails configured in the identified region. If there is at least one existing enabled trail, proceed to step 7.
- 3.
Create an Audit Trail: If no audit trails currently exist in the region, create a new audit trail by following the system-specific or software-specific guidelines. Ensure that the audit trail captures all relevant activities.
- 4.
Enable Audit Trail: If the created audit trail is not enabled, proceed to enable it using the appropriate settings or configurations. Enable the audit trail to start recording the specified activities.
- 5.
Test Audit Trail: Perform a test to ensure that the enabled audit trail is capturing the desired activities correctly. This step is essential to verify that the compliance requirement is being met effectively.
- 6.
Review Access Controls: Confirm that the relevant personnel have adequate permissions and access controls to maintain, monitor, and review the audit trail contents. Adjust permissions if necessary to ensure compliance.
- 7.
Validate Compliance: Once at least one enabled trail exists in the region, verify the compliance status by reviewing the documented regulations for GxP 21 CFR Part 11. Ensure that the audit trail aligns with the required parameters.
- 8.
Monitor and Document: Continuously monitor the audit trail(s) for any irregularities or deviations. Document any changes, updates, or incidents related to the audit trail(s) for future reference and reporting purposes.
By following these steps, organizations can ensure compliance with the requirement of having at least one enabled trail in a region for GxP 21 CFR Part 11.