Audit Trail and Electronic Records and Signatures (ERES)

21 CFR Part 11 Compliant
Ensure audit trail and data traceability with ComplianceQuest and streamline your compliance requirements.

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At ComplianceQuest we understand why maintaining an audit trail for all electronic records is crucial to ensuring accuracy, data integrity and compliance with regulatory requirements. That’s why the CQ platform includes robust audit trail functionality and electronic signatures, enabling our customers to track and monitor all activities that happen within CQ solutions and maintain compliance with 21 CFR Part 11.

Key Components of an Audit Trail

An audit trail is a chronological record of all activities performed within a system, including who performed the activity, what was done, when it was done, and why it was done.

An audit trail provides a complete picture of system activity, activities such as the creation, modification, and deletion of electronic records to help identify potential issues and investigate incidents.

Why Is an Audit Trail Important?

Maintaining an audit trail is especially important in highly regulated industries such as healthcare or life sciences, as it establishes trust in data and safeguards the integrity of electronic records.

More Importantly, audit trails are essential for regulatory compliance. The FDA's 21 CFR Part 11 regulation, which pertains to electronic records and electronic signatures, requires organizations to maintain accurate and complete records of all electronic activities, including changes, deletions, and additions to electronic records. In addition to regulatory compliance, an audit trail can also help organizations identify and address security breaches and fraudulent activity.

Requirements of 21 CFR part 11

According to the regulations set by the FDA, companies are required to maintain all their documentation in electronic format. If a business uses a closed system for record-keeping, it must adhere to the guidelines outlined in 21 CFR Part 11.10. Specifically, businesses using a closed system must implement protocols and safeguards to ensure the electronic records' authenticity, integrity, and confidentiality are maintained.

Validate the system to ensure the security and integrity of data records.
Implement an audit trail to track the development of a process, ensuring transparency and accountability.
Enforce restricted access to enhance security control and limit access to authorized personnel only.
Ensure that all system users receive the necessary training to perform their daily tasks.
Generate records with search and indexing functionality for easy retrieval and access.
Implement quality procedures to establish operational control over people and processes within the development cycle.
Use digital signatures organization-wide to streamline and expedite the approval process.

Complete Audit Trail Functionality with ComplianceQuest

The ComplianceQuest platform includes built-in robust audit trail functionality, enabling our customers to track and monitor all activities within the system. The CQ Audit Trail is used in all CQ EQMS products in order to support 21 CFR Part 11 and other compliance requirements in relation to e-signatures and record activities. Field Tracking can be setup for each CQ product as needed, supporting 60 to 100 fields per object, to capture all activities performed within the system, including changes to data, configuration settings, and user activities.

Enabling eSignatures with ComplianceQuest

With ComplianceQuest’s eSig settings you can rest assured your organization is protected and fully compliant with regulatory requirements, including 21 CFR Part 11. eSignatures can be enabled for various user transactions in CQ records, including Secondary Signature, Date and Time Stamp, and Password requirements for full compliance.

CQ eSig settings are available in all ComplianceQuest products in accordance with the 21 CFR Part 11 requirements and can be configured based on your specific business needs.