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Audit Trails: Your Map to Data Integrity

Audit Trails: Your Map to Data Integrity

November 9, 2020
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Technological advancements in pharma labs are making regulatory compliance increasingly complex. And that means audit trails are also increasing in importance.

What is an audit trail?

Audit trails are a secure, computer-generated, and time-stamped electronic record that allows for the recreation of a course of events. This can involve the creation, modification, or deletion of an electronic record. The purpose? Audit trails can provide much needed context for the creation and management of data. It enables insight into where and when errors were made in the process.

If you’re looking for the answer to who created the data, what was involved in its creation, where it was stored, and beyond, an audit trail will give you the answers. Lab supervisors can identify compliance issues when they know what to look for in audit trails.

Issues with compliance

Regulatory agencies are encouraging manufacturers to establish strategies for ensuring data integrity before even beginning their process.

Some key points that labs should look for on audit trails include:

  1. Account for the types of samples that were analyzed, what equipment was used, and what actions were taken with the samples.
  2. Keep track of time! You need to know when samples were run, but also if the relevant data was moved somewhere else.
  3. Other actions involving data need to be accounted for, such as: downstream processing, archiving, or restoration.
  4. Track human involvement, including human errors i.e. who performed the sample processing, what were the system administration updates including password changes, user additions and new access and permission.

How to approach compliance with lab staff

When it comes to compliance issues that are directly related to employees, the most useful approach is increasing education and training. Audits can be a useful educational tool because they provide insights to lab staff on blind spots.

It’s important to understand that humans make mistakes, whether from lapses in judgement or simple misunderstandings. Adequate training is necessary for providing staff with the context they need to perform their roles accordingly. There’s a demand for employees to perform as both scientists as well as data managers, which can lead to overwhelming responsibility.

With this in mind, many labs are pivoting to work with third-party consultants that can provide valuable recommendations with regard to compliance and data integrity. This can ease the burden on staff and prevent the toll and costs of non-compliance.

For more on the importance of audit trails, as well as their role in data integrity, read our white paper.

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