The Value of Audit Trails in a Biobank
Jul 13

The Value of Audit Trails in a Biobank

With biobanks, their raison d’être is to help researchers to make scientific breakthroughs using their tissue samples and the associated data. The value of the tissue samples to researchers, however, depends entirely on their profile, condition and the supporting evidence. In other words, the data. And lots of that data is built over time in the form of audit trails.

So, if you have a biobank, its effectiveness and value to an extent, depends on audit trails.

Think about compliance and external auditors

Data is required to evidence legislative compliance such as HTA and MHRA. Using a system that automatically maintains an audit trail of data changes can also evidence compliance with your Standard Operating Practices (SOPs). What’s more if that system is fully automated then it saves a lot of time. External auditors especially love that level of data being provided automatically. They will carry out spot-checks to confirm to themselves that the audit trails are complete and effective. This gives them confidence wherever else you’re producing those audit trails. It saves a lot of time during such audits and having happy auditors can make your lab staff much more relaxed and so the external audit becomes less stressful.

But what about non-compliances?

Well, having detailed audit trails can highlight poor practice as well as good, but this isn’t a bad thing. Once you know that something’s amiss with processes not being followed then you can address it, whether that’s by retraining or producing clearer instructions. It could be that it’s highlighted an issue with the process itself and then you can amend your process and your lab is better for it. Audit trails are brilliant.

And what about researchers?

Another brilliant feature of audit trails is that they aren’t just for you and your auditors. They are also very valuable to researchers. For a researcher to have confidence that your samples are the right ones for their research they need evidence of suitability and viability, for example, temperature logs and freeze/thaw cycle counts.

Having such an audit trail for samples makes those samples far more valuable to a researcher from a scientific perspective and therefore more valuable to your biobank in terms of cost recovery.

How to keep data manageable

You also need to think about the manageability of all this automatically generated data, though. Even if you forget about it the system keeps generating it. That means that you will need to periodically consider trimming data that’s no longer valuable. For example, how long after a sample has been issued or depleted will you need its full audit history? Maybe until after your next external audit? You could schedule a periodic data cleanse process that scans for depleted samples, an arbitrary number of years ago and automatically delete or archive the associated audit trails. Alternatively you could trigger such a cleardown after a successful external audit.

Even so, your data will continue to grow and that’s when analysis tools designed for processing large data sets come into their own. One great tool is a dashboard. That presents aggregated data in simple graphical charts and is great for identifying patterns in such data.

Final thoughts about the value of audit trails for biobanks

Audit trails are a biobank manager’s friend. They help you with your job, identifying good practice and bad. External auditors love them and they help to make formal audits less stressful. Researchers also value them as they provide confidence in the quality and viability of your samples. Finally, that research confidence makes the samples more valuable which is what biobank funders are looking for. Now, who doesn’t like a good audit trail?



About The Author

Gary Rooksby has over 25 years’ experience implementing and evolving corporate systems including manufacturing and quality systems for a range of major clients such as the MOD. For the last 18 years Gary has specialised in Sample Management Software with emphasis on process optimisation and data management. Gary works in partnership with clients and draws on his wealth of experience to help institutes and their teams to maximise the benefits from new and upgraded systems. Business needs are constantly evolving, and Gary loves the changing challenges. Gary always focuses on delivering value to the users, whether that is financial, scientific or simply easing workloads. He believes that the system is never an end in itself; it is a tool to help the users achieve their goals and that principle is always at the heart of any system or data designs.