Human Tissue Act Compliance Archives - INTERACTIVE SOFTWARE

How a LIMS Helps You Manage Quality Control in Your Lab or Biobank

Sharon Williams — Mon, 25 May 2020 08:00:23 +0000

Many labs and Biobanks choose to implement a Laboratory Information Management System (LIMS) to help them meet regulatory compliance. When you’re frantically preparing for the auditor’s visit it’s difficult to remember that the purpose of regulation and compliance is to ensure quality and safety. When using spreadsheets to track your samples and lab processes, it’s often impossible to record everything. And what you do capture may not be consistently recorded. Without accurate and complete data, you may lack confidence in your samples, processes and results. It might also take you longer to find the samples you need to carry out your work. Likewise, if you’re using several separate systems with information diluted or, even worse, duplicated across your labs. A LIMS system is designed to centralise your data, improving its integrity and quality. But a LIMS just doesn’t help with quality control in data – it also helps monitor your processes, samples, equipment and team. Plus, it helps instil consistency by enforcing your processes. All this helps you to meet regulatory compliance and manage quality in your lab. The importance of data You rely on your data to help make important decisions and assess the performance of your lab or […]

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Biobanking Systems and LIMS Supporting Regulatory Compliance Changes

Gary Rooksby — Mon, 23 Mar 2020 09:12:26 +0000

Legislation in any well-functioning industry evolves over time. Life sciences and clinical research are no exception. Becoming aware of those changes in good time to meet regulatory compliance is your first issue. However, regulatory bodies such as the Human Tissue Authority (HTA) issue advanced notifications about proposed changes to the licensees. So, you should have a “heads up”. Now, you’ll have to consider whether the change is relevant to you. Plus, you’ll need to consider whether you need to change your Standard Operating Procedures (SOPs) to comply. If your Laboratory Information Management System (LIMS) is supporting regulatory compliance you’ll also need to think about what changes you’ll need to make to the software. Do you need to change anything to maintain compliance? You’ll need to review the legislative changes and decide whether they affect your lab operations. It might be that a clarification has been issued about processing donated tissues from a deceased donor. If your lab never processes tissues from the deceased then there will be no impact on you. However, even if a change doesn’t apply you still need to give it due consideration. And it’s worthwhile formally documenting the consideration, even if it results in no SOP changes. […]

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Using Biobanking software for compliance peace of mind

Sharon Williams — Tue, 12 Nov 2019 16:25:11 +0000

Two key challenges facing your lab or Biobank are quality and efficiency. You may introduce and follow a set of standard processes to address these. And, to be successful, everyone in your lab or Biobank must follow these processes too. These processes may form your Standard Operating Procedures (SOPs). You may have chosen them from your own best-practices or legislation such as the Human Tissue Act (HTA) and the Medicines and Healthcare products Regulatory Agency (MHRA). Or you may have chosen to follow industry-standard best-practices such as those outlined by the International Society for Biological and Environmental Repositories (ISBER) or ISO. Whatever processes you decide to use to improve quality and efficiency, how do you know that everyone is following them? And, importantly, if they’re working? If you can’t answer this, you may want to think about using Biobanking software for compliance management and tracking. Enforcing processes through your Biobanking software for compliance Advanced Biobanking software allows you to map your workflows and processes into the system. And some Biobanking software already has key processes built-in as part of the standard ‘out-of-the-box’ system. Achiever Medical, for example, has workflows to manage your sample receipts, storage, processing, and shipping – amongst […]

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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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5 key success factors for laboratory compliance

Gary Rooksby — Thu, 02 May 2019 16:34:59 +0000

Most people dread an audit and many businesses see compliance as something they have to do to get a ‘tick in the box’. However, with the right foundations and focus on building quality into your standard operating procedures, laboratory compliance can become your every day. As a technology business, we put ourselves through experience an ISO audit every year. We have also been present during our customers’ audits conducted by the Human Tissue Authority. So we understand how nerve-wracking compliance and accreditation inspections can be. Here are our 5 key success factors for laboratory compliance that we think can help remove some of the stress. 1. Know what you want to comply with and why Labs will often have a legal requirements for compliance, depending on the type of work they undertake. This may be the Human Tissue Act (HTA) if you handle cellular human tissue or the Medicines & Healthcare product Regulatory Agency (MHRA) if your work is in relation to drugs or medical devices. Compliance isn’t just about avoiding breaking the law, though. There are tangible benefits to your lab associated with running compliant processes. Think about those benefits and trying to maximise them. ISO standards such as ISO 17025 […]

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HTA Designated Individual and Licence Holder – are you confident that you are HTA compliant?

Sharon Williams — Thu, 21 Mar 2019 11:14:37 +0000

As an HTA Designated Individual you feel the responsibilities and challenges for compliance with the Human Tissue Act every day. You not only have an ethical and moral duty to comply but also a legal one. As an external HTA inspection nears, the question of whether you are HTA compliant may only increase your feelings of pressure. Especially if you do not have the required information readily available but instead rely on your researchers’ memories and notes. You may have a team of Persons Designate who provide you with information for a Human Tissue Authority audit. However, without a standardised way of managing this information, it can take hours to manipulate into a usable format. How much time would you save if you did not have to chase and pull together information prior to an audit? How much money would you save? What else would you be working on if you were not spending time doing this administrative work? How much would this benefit your organisation in terms of your reputation, achievements and services offered as well as financially? Using a laboratory sample management system to help your lab become HTA compliant As HTA Designated Individuals and Licence Holders a […]

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Next Generation Biobanks – Integrating Sample and Clinical Data

Sharon Williams — Tue, 26 Feb 2019 12:00:00 +0000

When the term ‘Next Generation Biobanking’ was introduced a couple of years ago, it underlined the importance of storing clinical data, such as diagnosis, clinical trial and treatment information alongside sample data. You measure your Biobank’s value on how you optimise and use your samples in investigative research. Not by counting the number of samples you hold. Storing and maintaining your samples is expensive. And unless the samples you are holding in your Biobank provide significant value in research; you will end up wasting valuable time, money and resources storing and preserving those samples. Your role as a Biobank is becoming increasingly important to researchers. You need to be visible, accessible and able to provide high-quality samples that they can use in scientific research. With the emergence of precision medicine; your ability to provide accurate, detailed clinical information against each sample, including demographic data, lifestyle information, diagnosis and treatment history is essential. As a result of this, you are able to offer highly specialised biological material that can offer invaluable insight such as helping identifying trends, common risk factors or indicators. The expectations of researchers have also changed as a result of advances in technology and an increasingly competitive marketplace. […]

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The benefits of sample management software in research sample selection

Sharon Williams — Tue, 05 Feb 2019 16:13:36 +0000

‘Are you aware that your selected research samples are from only 3 donors?’ We asked this question to one of our customer’s after we imported their data into our lab sample management software, Achiever Medical. The import included information taken from several spreadsheets. And it was only when we imported this data into the system that we could all see the bigger picture – and the possible implications. The spreadsheets contained data about hundreds of samples – and on the face of it seemed to offer a wide variety of samples that could be used for research. Yet it was only when we imported it into Achiever Medical that we could see the samples grouped by individual participant – and this gave us a completely different – and important – perspective. The benefit of using software – in this case a LIMS – for sample management was apparent immediately. Consolidating and standardising your laboratory information and sample data Storing your data in spreadsheets has its benefits – quick, easy and cheap to name a few. But they don’t always give you the complete picture of your data. When our customer looked at their data in the spreadsheets, it was not […]

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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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