Corrective and Preventive Actions (CAPA) Audit Trail in Lyons Quality Audit Tracking System (LQATS)

Here’s what you need to know to with regards Corrective and Preventive Actions (CAPA), specifically focusing on electronic event tracking in Lyons Quality Audit Tracking System (LQATS) related to suppliers.

  1. Audit Trail Definition:

    • According to the FDA’s guidance for industry, an audit trail is defined as: “A secure, computer-generated, time-stamped electronic record that allows reconstruction of the course of events relating to the creation, modification, and deletion of an electronic record.”
    • In simpler terms, an audit trail is the history of all actions performed in a document. It includes details such as who performed the action, when it occurred, which action was taken, and any other relevant information.
    • Audit trails enable tracking the time-sequence development of documents to ensure they haven’t been altered in a way that compromises accuracy or reliability.

  2. 21 CFR Part 11 Audit Trail Requirements:

    • The FDA 21 CFR Part 11 regulation mandates that systems managing electronic records provide a secure, computer-generated, and time-stamped audit trail.
    • The purpose of this audit trail is to accurately record changes made to documents.
    • Key requirements outlined in 21 CFR Part 11 section 11.10 include:
      • Ensure Audit Trail Security: Only authorized individuals should have access to the system for making changes and signing off documents.
      • Record All Activities: The audit trail must capture all relevant activities related to document creation, modification, and deletion.
      • Traceability: It allows for the reconstruction of events if an investigation is required.
      • Accuracy and Reliability: The audit trail ensures that electronic records remain intact and unaltered.

  3. Benefits of Implementing Audit Trails:

    • Transparency: Audit trails provide transparency into document changes and actions taken.
    • Compliance: They are crucial for regulatory compliance (such as 21 CFR Part 11).
    • Accountability: Authorized users are accountable for their actions.
    • Forensic Investigation: In case of discrepancies or issues, audit trails facilitate thorough investigations.
    • Quality Assurance: Ensuring the accuracy and reliability of electronic records.

Remember that an efficient electronic CAPA system enhances collaboration, accountability, and overall quality management. By embracing technology, organizations can proactively address issues and continuously improve processes.