Laboratory Audit Archives - INTERACTIVE SOFTWARE

The Value of Audit Trails in a Biobank

Gary Rooksby — Tue, 13 Jul 2021 10:00:35 +0000

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. […]

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5 Challenges of Using Spreadsheets to Track Sample Movement

Sharon Williams — Mon, 07 Jun 2021 16:52:49 +0000

Each sample’s journey is a complex one. As a sample moves from initial collection to depletion it passes through the hands of numerous people. Even the simplest journey involves two people where a clinic nurse takes a sample and then a scientist processes it. But it’s usually not quite that simple. What’s more, tracking sample movement isn’t just about recording what’s coming into your lab but what you’re sending out to others to use, store or process. Successful research studies, testing activities and clinical trials require close collaboration between several internal and external teams. So, it’s highly likely that you’ll be moving your samples between different locations and people many times before you finally deplete them. Keeping track of sample movements can be challenging, especially if you’re using a spreadsheet. Why tracking sample movement matters Having full traceability of your samples is essential for any lab. Firstly, it helps you understand each sample’s provenance in order to assess its suitability for your work. Secondly, you know what’s happened to it including who has accessed and worked with it. This helps you assess its viability. Finally, and most importantly, you need to make sure that you – and your collaborators – […]

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Using a LIMS to track and audit sample movement

Sharon Williams — Fri, 20 Nov 2020 10:40:18 +0000

Each sample’s journey is a complex one. A sample may be handled by many people as it moves from initial collection through various states and stages to final depletion. It may travel hundreds of miles. You may freeze and thaw it a couple of times. What’s more, you may split, slice, analyse and process it beyond recognition. So, when it comes to choosing a sample for testing, clinical trials or research are you confident it’s going to be viable? And can you trace everything that you’ve done to it. With Achiever Medical laboratory information management system (LIMS) you can track and manage the movement of every sample. As a result, you know exactly where each sample came from, where it’s been, who’s done what to it, where it is now and, importantly, how you can ethically use it. Do you really know your sample’s origin? Understanding a sample’s provenance can help you assess its viability. Knowing exactly why a sample was taken, where it was taken and how it’s being stored are just the first steps to understanding if you can use it. Then there’s the informed consent. This details a patient’s wishes in how they want you to use […]

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5 Reasons – other than Compliance – why you should be Auditing your Lab Data

Sharon Williams — Fri, 17 Jul 2020 12:13:58 +0000

Being able to evidence where your samples have come from, what’s happened to them and where they are now is important for regulatory compliance. But that’s not the only reason why you should be auditing your lab data. Being able to see when a sample record was created and who updated the record last allows you to see how old your samples are and if anyone is using them. Tracking this information in a spreadsheet is difficult. And even if you do manage it, it takes time and the accuracy of the data is questionable. A laboratory information management system (LIMS) takes care of auditing for you. Automatically updating the audit trail as you add or modify data in the system. But auditing is not just limited to tracking creation and changed dates. Your audit data can give you valuable insight to help you improve efficiency and quality. What’s more, it can increase confidence in your results and support your decision making. Even helping you to choose which samples are best to use for which type of work. 1. Improving your productivity Most LIMS will have an audit for when a record is last created or changed and include the […]

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LIMS CAPA Management for Process Quality Control and Improvement

Gary Rooksby — Tue, 14 Apr 2020 08:00:04 +0000

Efficient and standardised business processes are fundamental to the effective running of a lab or biobank. That’s why it’s so important to have clearly documented Standard Operating Procedures (SOPs). Hopefully your SOPs closely match your business requirements and everything’s nice and rosy. But what if they don’t? Or if your business needs change? In that case you need to update your SOPs. This might include documenting the issue or change as well as noting any corrective and preventative actions (CAPA). You want to be able to handle these updates efficiently. After all, you’ve all got your day job to be getting on with. Could a laboratory information management system (LIMS) help you manage such SOP changes along with any associated CAPA? Audits to the rescue So, how do you ensure that your SOPs are still working effectively? Well, an audit works well. But the mere mention of an audit can strike fear into the hearts of many. Done badly they can be really intrusive and disruptive to the normal work processes and that’s counterproductive. If the act of reviewing a process causes that process to change then it’s not capturing a true result. Really effective audits need to be light […]

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Building proactive lab auditing into your daily routine

Gary Rooksby — Thu, 10 Oct 2019 15:51:19 +0000

The thought of a lab audit might be enough to bring you out in a cold sweat. The dread of an audit for some is akin to a phobia. Desensitisation is said to be the most effective cure for a phobia – would this approach work for audits, too? Making lab auditing a part of your daily routine so it becomes habit might sound difficult. If it’s built into your everyday processes – it no longer becomes something extra for you to think about. But where do you start? As the start of the well-known phrase goes ‘little and often…’ If you carry out a little audit work on a regular basis it quickly becomes a part of your weekly or daily routine. And you can do this without a major impact on your workload. You could schedule, say, an hour each Friday afternoon to spot-check your samples and processes carried out during the week. If you then log the results in a formal log, you will quickly build a body of testing evidence to show management and the external auditors when the time comes. It also means that you’ve got a good chance of spotting an error – and […]

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‘Hello Audit!’ – A proactive approach to improving lab and sample quality

Sharon Williams — Thu, 06 Dec 2018 11:29:59 +0000

‘Audit’ – the mere mention of the word can strike fear into the heart of even the most experienced and organised of laboratory managers. You can spend hours – sometimes weeks – preparing for an external audit. You can spend time collating information, formatting documents, and ensuring your teams is ready to handle any questions that may be directed towards them. Thank goodness they only take place every couple of years! But what if you look at audits differently – as a means of improving lab and sample quality? Sample tracking software and laboratory information management system (LIMS) can help you instil quality and traceability into your daily processes. The right software systems implemented with the relevant workflows can help ease some of your administrative burdens around data management for audit compliance. What if you were to go one step further and carry out your own internal audits? The thought of carrying out your own internal audits and quality control checks may bring you out in a cold sweat! You don’t have time to regularly spend hours getting your information together to check its quality. This is where sample tracking software can help – quickly pulling together your information and […]

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Surviving the dreaded audit

Gary Rooksby — Sun, 20 May 2018 16:47:03 +0000

Hands up who loves to be audited! In truth, not many people relish the idea of an upcoming audit. They are often perceived as a looming black cloud and that they get in the way of the day-to-day work or a lab or tissue bank. However, a good audit can really add a shine to your institute’s reputation. With some forethought, and audit management, they can become much less stressful and largely positive experiences. There’s nothing like the warm glow of reading the conclusions section of an audit report and seeing positive points and approval. Good news also spreads upwards through the management chain. Everyone loves praise! The reality of audits – they’re unavoidable Audits arrive when you least need them so it pays to always be prepared. If you can carry out your own audits periodically that allows you to spot failures in operating procedures, identify process optimisations. And – importantly – this allows your team to validate their designated processes and check that they’re actually adhering to them. It also provides documentary evidence of your lab or tissue bank process review. Auditors just love that! It’s for this reason that Achiever Medical has added the Audit Management module helping […]

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