Audit trails play a crucial role in ensuring data integrity, traceability and compliance with Good Manufacturing Practice (GMP) regulations. Under the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-16), Annex 11 outlines specific requirements for computerised systems, emphasising the need for audit trail reviews. However, organisations often face challenges in effectively implementing this process and in the landscape of Industry 4.0, 5.0 and the growth of data generation this challenge is becoming more critical.
Many companies SeerPharma work with are currently reviewing audit trails every 6 or 12 months. This is time-consuming and ineffective as, by the time the audit trails are reviewed, the batch has already been released. This article discusses these challenges and highlights a risk-based approach - conducting computerised system audit trail reviews before each batch is released - to maintain compliance and operational efficiency.
Challenges and Regulatory Requirements
Volume and Complexity of Data
Modern pharmaceutical manufacturing and quality systems generate vast amounts of audit trail records, making it difficult to identify critical changes amidst routine entries. Reviewing every entry across multiple systems, each with their own audit trail format, is overwhelming. Many audit trail reviews rely on manual examination of logs, which is time-consuming and prone to human error. The absence of validated automated filtering and analysis tools can make it difficult to detect anomalies effectively.
Lack of Standardised Review Processes
Inconsistent approaches across teams or sites can lead to gaps in compliance. Some organisations review audit trails infrequently, increasing the risk of missing critical data modifications or unauthorised changes. Additionally, PIC/S Guide to GMP Annex 11 mandates that audit trails be available, reviewed and retained. However, the regulation does not specify the frequency of review, leading to varied interpretations and potentially inadequate oversight.
Human Readability Requirement
Both PIC/S Annex 11 and 21 CFR Part 11 require audit trails to be intelligible and human readable. It is crucial for compliance that organisations review and interpret audit trail data effectively. The ability for a human to review audit trails ensures that anomalies can be detected, understood and investigated appropriately, reinforcing the importance of well-structured and accessible audit trail records.
A Risk-Based Approach to Audit Trail Review
To overcome these challenges, a best practice is to review the audit trail immediately before each batch release. This risk-based approach aligns with GMP principles by ensuring that any deviations, unauthorised changes, or system anomalies are detected and addressed promptly. Efficiency is facilitated because of the reduced volume of data review, being only records relating to the time of production or scope of the current batch.
Further efficiency is gained with an audit trail system that includes a validated exception report, meaning organisations can adopt a review-by-exception approach, focusing on flagged or high-risk entries rather than manually reviewing all records.
Critically, the audit trail review for a batch may require reviewing data from multiple computerised systems, ensuring a comprehensive assessment of compliance and data integrity.
Benefits of This Approach
- Enhances Patient Safety, Data Integrity and Compliance
- Ensures that discrepancies are resolved before product gets to market with a more robust and justified review process.
- Reduces Workload Burden and Risk of Error
- Frequent reviews break down the audit trail into manageable portions, minimising the risk of overlooked entries.
- Improves Investigation and Corrective Action
- Timely review allows for quicker root cause analysis and corrective actions, preventing systemic failures.
- Facilitates Real-Time Monitoring
- Automated tools can streamline the review process by flagging anomalies and integrating with batch release workflows.
Implementing an Efficient Audit Trail Review Process
To successfully implement batch-based audit trail reviews, organisations should consider the following steps:
- Develop a Standard Operating Procedure (SOP)
- Define clear roles, responsibilities and review criteria, incorporating risk assessment principles to focus on high-impact areas.
- Utilise Automated Tools
- Leverage audit trail analysis software to implement risk-based filtering & flagging of relevant records and integrate alerts…and validate it.
- Train Personnel
- Ensure that operators, quality assurance personnel and IT teams understand audit trail requirements and emphasise risk-based thinking.
- Maintain Documentation and Audit Readiness
- Ensure proper documentation of reviews, maintain a well-organised archive and establish a risk-based escalation process for critical findings.
Conclusion
An effective audit trail review process is essential for maintaining compliance with PIC/S GMP Annex 11. Implementing a risk-based approach by reviewing audit trails before each batch release enhances data integrity, reduces compliance risks and improves operational efficiency. By leveraging automation, risk prioritisation and clear review protocols—including a review-by-exception approach when audit trails are validated—organisations can ensure robust compliance while minimising manual effort and regulatory exposure.
SeerPharma can assist your organisation with defining a process for this streamlined approach. If you would like more information or support in implementing an efficient audit trail review process, please contact us.
