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The Pitfalls of Manual Audit Trail Reviews in GxP Systems…And How To Avoid Them.

In the highly regulated Pharmaceutical and Biotech industry, adherence to Good Manufacturing Practice (GxP) guidelines is paramount to ensure product quality, patient safety, and regulatory compliance. Audit Trail reviews of the GxP systems involved in the process is a fundamental activity for all regulated organisations.

Traditionally, audit trail reviews of GxP systems have been performed manually, requiring personnel to sift through vast amounts of data to identify deviations, anomalies, or potential compliance issues. While this approach has been the norm for years, it is not without its challenges and limitations, which can undermine the effectiveness of compliance efforts.

Human Error and Oversight:

Manual audit trail reviews are inherently prone to human error. Reviewers may miss critical information due to overload, oversight or fatigue, leading to incomplete assessments of system activities. Additionally, subjective interpretation of audit trail data can vary among reviewers, resulting in inconsistencies and discrepancies in identifying non-compliance issues.

Time-Consuming and Resource-Intensive:

Manual review processes require significant time and resources to execute effectively. Personnel must dedicate substantial hours to comb through audit trail data, diverting attention from other critical tasks. Moreover, as data volumes continue to increase with the digitalization of GxP systems, manual reviews become increasingly laborious and impractical.

Limited Scalability and Flexibility:

Manual audit trail reviews struggle to scale with the growing complexity and volume of data generated by modern GxP systems. As organisations expand their operations or adopt new technologies, the manual review process may become overwhelmed, leading to delays in identifying compliance issues. Furthermore, manual processes lack the agility to adapt to evolving regulatory requirements and organisational changes efficiently.

Risk of Inconsistencies and Inaccuracies:

Without standardised procedures and automated tools, manual audit trail reviews are susceptible to inconsistencies and inaccuracies in data interpretation and analysis. Different reviewers may apply varying criteria or thresholds when assessing audit trail data, leading to disparate outcomes and misalignment in compliance determinations. Moreover, manual data entry and documentation processes increase the risk of transcription errors and data manipulation, undermining the integrity of audit trail records.

Regulatory Scrutiny and Compliance Concerns:

Regulatory authorities, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), place a strong emphasis on the integrity and reliability of audit trails in GxP systems. Manual audit trail reviews may not meet regulatory expectations for thoroughness, accuracy, and timeliness, potentially exposing organisations to compliance risks, enforcement actions, and reputational damage.

Addressing the Challenges

To mitigate the problems associated with manual audit trail reviews, Odyssey VC has recently launched ATReview – A cloud based system enabling you to transform manual periodic reviews into real time audit trail management.

The implementation of automated tools like ATReview allows organisations to finally streamline audit trail reviews, enhance data accuracy, and identify patterns or anomalies indicative of non-compliance.

Using ATReview for GxP system audit trail management reduces the burden on human reviewers and allows for standardized procedures and validation protocols for audit trail reviews to ensure consistency, reproducibility, and compliance with regulatory requirements.

With configurable parameters, ATReview has enabled organisation to define clear criteria and thresholds for identifying deviations or discrepancies in audit trail data and automated, real time auditing removed many of the pitfalls associated with periodic delays.

Conclusion:

Manual audit trail reviews present significant challenges and limitations in ensuring GxP compliance within regulated industries. By embracing automation, organizations can enhance the effectiveness, efficiency, and reliability of audit trail review processes, thereby safeguarding product quality, patient safety, and regulatory compliance in an increasingly complex and dynamic regulatory landscape. You can find out more about ATReview by contacting one of our experts.