Audit trails are crucial in Quality Control (QC) for tracking changes, identifying who made those changes, and ensuring compliance with regulations like FDA's 21 CFR Part 11 or EMA's Annex 11. Here's why CSV might fail during audit trail checks in a QC environment and what can be done to mitigate these risks:
Causes of CSV Failure in Audit Trail Checks
1. Insufficient Documentation: Failure to maintain detailed records of validation processes, including test scripts, user requirements, and validation plans, can lead to CSV failure during audit trail checks.
2. Improper Configuration of Audit Trails: Audit trails must be configured to capture relevant data, including changes to records, the identity of users making changes, and timestamps. Incorrect configuration can lead to incomplete audit trails.
3. Lack of Access Controls: If unauthorized personnel have access to systems with audit trails, there's a higher risk of data tampering, leading to CSV failure.
4. Failure to Meet Regulatory Requirements: Non-compliance with industry regulations like 21 CFR Part 11 can cause CSV to fail during audit trail checks. These regulations mandate specific audit trail features and record-keeping practices.
5. Inadequate Testing: Validation testing should cover all scenarios, including boundary cases and edge cases. Inadequate testing might miss critical audit trail failures.
6. Poor Change Management: Without a robust change management process, alterations to systems or audit trail configurations can lead to CSV failure due to unintended consequences or undocumented changes.
7. Data Integrity Issues: Problems like data corruption, accidental deletions, or undetected changes can compromise the integrity of audit trails, leading to CSV failure.
#gmp
#CSVpharmaceutical
#csvfailure
#audit trial
Cutting-Edge Tech Enthusiast | AI Advocate | Lifelong Learner | Public Speaker | Industry Evangelist | Shaping the Future | Honeywell
9moContinuous monitoring is a great idea! What are your thoughts on CSA? Inverting the documentation piramid to focus more on intended use and risk seems like a good next step 💡!