Risk-Based Approach to Reviewing Data and Audit Trails in Empower 3

Audit trail data is essential for compliance, and it has operational benefits. Regulators, including the FDA and European regulators, publish guidance that outline the parameters for maintaining audit trail data. Systems like Empower 3 provide the required functionality.

How to operate within the parameters set out by regulators is up to each individual pharmaceutical organization. It’s also up to you how you use the functionality provided by Empower 3.

One area that can often be optimized is the work of reviewers. By taking a risk-based approach to reviewing data and audit trails in Empower 3, you can significantly enhance the efficiency of your operations while maintaining data integrity and ensuring compliance.

Benefits of a Risk-Based Approach to Reviewing Data and Audit Trails in Empower 3

Operational Efficiency

A risk-based approach ensures reviewers focus on high-impact GxP data. This concentrates your lab resources where they are needed most, reducing the burden of carrying out time-consuming checks on data that is less GxP critical.

Regulatory Compliance

Regulators, including the FDA in the US and European regulators, encourage compliance strategies that are risk-based. Regulators want pharmaceutical organizations to focus their resources and processes on data that poses the highest levels of risk to data integrity, product quality, and patient safety.

Data Integrity

High-impact data integrity issues are those where the data is GxP critical. Focusing review efforts on data that is GxP critical helps to identify, mitigate, and prevent high-impact data integrity issues from occurring.

How to Implement a Risk-Based Approach to Reviewing Data and Audit Trails in Empower 3

1. Align Empower 3 Workflows with Business Processes

Start by clearly defining your Empower workflows to reflect your lab’s operational and compliance needs. This requires an understanding of the steps analysts follow during data acquisition and result generation. Examples include:

• Points of data creation and modification
• System interactions involved in processing and reporting
• Areas where manual intervention occurs

By documenting and analyzing these activities, you can identify areas of concern, evaluate both technical and procedural controls, and pinpoint potential risks. This risk assessment should then inform the structure of your reviewer workflows, helping reviewers focus on high-risk areas during their evaluations.

2. Ensure SOPs Are Practical and Enforceable

You should ensure your procedures and policies are both compliant and practical. Importantly, avoid implementing controls that are overly burdensome or unrealistic for routine execution. When Standard Operating Procedures (SOPs) are reasonable and aligned with actual workflows, reviewers will be more able to complete tasks consistently and effectively.

3. Educate Analysts and Reviewers

Well-trained personnel are key to reliable, risk-based decision-making. Therefore, provide comprehensive training to both analysts and reviewers on your risk-based approach. Training tips include:

• Educate analysts and reviewers on workflow steps and Empower 3 functionality.
• Emphasize the specific risks reviewers should focus on during data reviews.
• Ensure reviewers can confidently assess data accuracy, traceability, and level of compliance according to expectations.
• Reinforce the importance of data interpretation as a critical skill.

4. Enhance Automation to Reduce Risk

Wherever possible, automate calculations and data handling to reduce your laboratory’s reliance on manual processes as manual processes are prone to human error. Transcription is one example where automation is particularly effective at eliminating mistakes.

As well as eliminating mistakes, automation also:

• Enhances operational efficiency
• Ensures consistency in results generation
• Improves the accuracy, reliability, and quality of reporting

Summary: Implementing a Risk-Based Approach to Data Review

A structured, risk-based strategy for data review, alongside empowered reviewers, practical SOPs, and thoughtful system design, ensures compliance and data integrity. It also enhances product quality and patient safety, while fostering a culture of accountability and data integrity within your laboratory.

Recommendations for Optimizing Data Review SOPs in Empower 3

To ensure data integrity and compliance, the following recommendations should be considered when developing or refining a data review SOP for Empower 3:

Prioritize Reviewing Within the Application

Where possible, electronic data reviews should always be conducted directly within the Empower 3 application. At a minimum, this should be the case during peer-level reviews.

Conducting reviews within the application allows reviewers to examine the original source data and metadata in its native format. This is a better approach than relying solely on printed reports or PDFs, as they may lack the full context and/or traceability capabilities.

Eliminate Redundant Review Efforts

To optimize efficiency, avoid unnecessary duplication of effort by clearly defining whether reviews should occur within the system or via generated reports. Reviews should not be conducted on both.

For example, if a reviewer has already conducted a thorough review within Empower 3, it is inefficient to repeat the entire process through a report-based review. Your data review SOP should clarify the primary review method to ensure reviewers focus their time effectively.

Define a Clear and Risk-Based Review Workflow

Your data review SOP should include a structured review sequence that is tailored to your lab’s workflows and identified risk areas. For example, begin by reviewing reported results, then work backward through the data trail, including sample sets, processing methods, and injections.

It’s also important to pay close attention to predefined risk indicators. Examples include:

• Manual or repeated integrations
• Changes to sample information after data acquisition
• Unprocessed injections
• Results that narrowly meet specification criteria

Summary: Optimizing Data Review SOPs in Empower 3

Best practices for optimizing a risk-based data review SOP in Empower 3 include:

• Ensure reviews within Empower 3 are the priority.
• Where reviews via generated reports are necessary, make sure there is no duplication of effort.
• Define a clear data review workflow in the SOP, including working backward through the data trail while focusing on predefined risk indicators.

By incorporating a risk-based approach into the data review SOP, labs can ensure reviewers maintain focus on areas that are most likely to impact data quality and regulatory compliance.

High-Level Empower 3 Data Review Pyramid

The Empower Data Review Pyramid provides a structured, top-down approach to reviewing data, aligning the roles of both analysts and reviewers to ensure compliance and efficiency.

Analyst Workflow (Right Side – Ascending Path)

The workflow of analysts is represented on the right-hand side of the pyramid. This side of the workflow begins with the selection of the appropriate system and project. It then progresses through to data acquisition, processing, and result generation. Throughout the workflow, analysts perform a series of interactions within the Empower 3 system to reach the point of Review and Sign-Off.

Reviewer Workflow (Left Side – Descending Path)

In contrast, the reviewer’s workflow begins at the top of the pyramid with the final, signed-off results. From there, the reviewer works backward through the data trail, verifying that:

• All activities leading to the result were appropriate
• Methods and processing parameters were applied correctly
• Audit trails reflect legitimate, justified actions
• No unapproved or unexplained changes were made

This top-down review ensures the reported result is fully traceable and compliant with both internal procedures and regulatory expectations.

The Importance of System Controls and Access Management

Effective control of project and system access is essential to reducing unnecessary audit trail entries. System controls and access management are also essential for maintaining data integrity. Key elements include:

• Defining and managing user privileges via a User Privilege Matrix
• Controlled access to projects and system functions
• Ensuring strict procedural guidance for method creation and modification
• Limiting who can perform data modifications

With the risk of unauthorized changes and irrelevant audit trail entries minimized, reviewers can focus their attention on GxP critical elements. This includes:

• Are integration adjustments justified and appropriate?
• Are there signs of orphaned or unexplained data entries?

By controlling analyst access and enforcing procedural discipline, the volume of audit trail data also becomes more manageable. This further helps reviewers concentrate on assessing the quality and authenticity of data, rather than chasing preventable issues.

Conclusion: A Risk-Based Approach to Reviewing Data in Empower 3

A risk-based approach to reviewing data in Empower 3 is beneficial for operational efficiency, regulatory compliance, and data integrity.

Best practices for implementing a risk-based approach include aligning Empower 3 workflows with business processes while ensuring SOPs are practical and enforceable. Training both analysts and reviewers is also important, as is maximizing automation to reduce human error.

Creating effective SOPs is a crucial part of moving to a risk-based data review approach in Empower 3. The best advice when developing your SOP is to prioritize reviewing within the Empower 3 application while ensuring there is no duplication of effort when this is not possible, i.e., when reviewing generated reports is part of the workflow, don’t also review the same data within the system.

The workflow of your data review SOP should also be clear and aligned with the needs of your lab. Empower’s Data Review Pyramid provides a template for creating both analyst and reviewer workflows.

Putting in place robust access management and system control processes is also important.

At Westbourne, we can provide strategic, practical, and ongoing support in all the above areas, helping you transition to a risk-based approach for reviewing data in Empower 3. Get in touch to arrange a consultation.

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