Product Manager and Business Analyst

5 Essential Tips when Specifying Your LIMS User Requirements

Gary Rooksby — Thu, 19 Aug 2021 14:39:51 +0000

So, you’re looking for a new Laboratory Information Management System (LIMS). Maybe your Excel-based systems are creaking or you’ve recently had an external audit and the auditors strongly recommended that you need a new system. Or maybe you’ve received some new funding due to an expansion in your lab’s workload. Whatever the reason, when you’re asked to detail your requirements for a new LIMS it can be an onerous task documenting and prioritising everything you need. Plus, there’s always that worry that you’ve forgotten to include an essential feature in your LIMS user requirements specification! 1. Think about your lab processes – not how your current system works It’s very tempting to start by documenting how you currently work and outline small changes that address the challenges you face when using your existing systems. This method will identify some “quick wins” but is likely to miss major improvements that you could gain from optimising your processes. Making an inefficient process slightly smoother misses the big win. Step back and think about how you’d like to work and what you can reduce or even eliminate. For example, if you spend ages searching for informed consent in your document management system that […]

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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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Who Has Time to Cleanse Date/Time Data?

Gary Rooksby — Fri, 23 Apr 2021 10:00:03 +0000

Text data that needs to be matched with pre-defined data sets is often seen as most challenging. But what about innocuous date and time fields – surely they can’t be difficult? Oh yes they can! Here are four tips to avoid many potholes and maintain data accuracy. Tip 1 – Be consistent There are two distinct types of time-related data – points in time and durations. Points in time, such as dates of birth may simply require the date. However, sometimes a time element is very important e.g. when a sample was taken or frozen. Always use the same data type for storage – “Datetime” is best. Durations are more challenging. You need to be clear about the accuracy you need. Do you need a number of hours, minutes or seconds or even higher accuracy? Once you have your definition you must stick strictly to it for that field. You can then record the number of units – the lowest unit e.g. seconds, as an integer. Tip 2 – How are empty values interpreted? The rules around what “empty” means can be vague for date fields and this is the most common issue. However, making such a field mandatory doesn’t […]

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5 Tips on Cleansing External Data Before Importing into a LIMS

Gary Rooksby — Thu, 18 Mar 2021 11:43:19 +0000

You have a data set and you know what your target LIMS system can import. So, how do you turn one into the other? It can be a real challenge to manipulate data files and half the problem is understanding the assumptions and implicit rules in the original. We briefly covered those in an earlier blog (Overcoming the Challenges of Cleansing Data to Import into a LIMS) so let’s think about the specifics. 1. Understand fully what is required Understand the required resulting format fully so that you have a clear target towards which you can work. And don’t try to use one tool for every task. Excel is great for many things but not all. It’s not good, for example, at differentiating and processing empty text values mixed with null values. A free utility such as Notepad++ is much better for that but can’t do pivot tables. Use the right tool for the job. 2. Data types Be clear about whether a particular field in your new system is expecting just a date or a date and time. SQL databases tend to use the same underlying data type and reformat the output. Input, however, is much fussier. Be consistent. […]

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Overcoming the Challenges of Cleansing Data to Import into a LIMS

Gary Rooksby — Fri, 19 Feb 2021 10:35:12 +0000

Imagine you need to import a data set into your Laboratory Information Management System (LIMS). Perhaps you’re taking on a new study and need the historic data or are merging labs with another team. Whatever the cause the result is the same. You’ve got a spreadsheet of data of unknown quality that needs to be “knocked into shape” before import. What do you do? Where do you even start when it comes to cleansing data to import into a LIMS? 1. Understand what each column is supposed to represent You need to properly understand what the data means. Whether you’ve got Yes/No, Y/N or 1/0, you need to know what this meant to the team entering the data originally. If the fields are, say, consent options then does “Yes” mean the donor opted in or opted out? It’s very important to understand the meaning. And what do you do with an empty value? 2. Agree your terminology Choose the list of valid options. The technical term is ontology. These are often already set up in your LIMS, although they’re not always complete. You may be expanding the scope of your data with, say, a new study so new picklist options […]

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Planning for Data Quality with Limited Resources

Gary Rooksby — Thu, 28 Jan 2021 09:47:04 +0000

Whose job description includes “ensure that the data you use and record is of maximum quality”? Not many. However, it’s an absolute requirement of pretty much anybody in the modern workplace. Data is king. Good data can inform business decisions that bring immense success. But, equally, bad data can cripple a business. So, we know it’s important but we will rarely have time to stop our daily job and work on improving the quality of data we already hold. We need tweaks to our processes that maximise quality as we go along. Assign Ownership Who’s responsible for the data that needs to be cleansed? If it’s “everybody” then nobody will take responsibility. Ensure that for each piece of data your whole team knows who, specifically, is responsible for its quality. Think what it’s needed for and by whom If a set of data has only a single use or few users then it’s easy to scope the data quality requirements. If it’s for general use by many users then you need to think harder about accuracy, completeness, period of validity, etc. Understand limits to quality of existing data If you’ve inherited a set of really poor data then consider the […]

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Are you Biobanking or Bio-hoarding?

Gary Rooksby — Wed, 09 Dec 2020 15:03:39 +0000

I was watching an excellent presentation by Prof Daniel Catchpool, the current president of ISBER, at the Europe Biobank Week 2020, and he raised this specific question in a very insightful way. Anyone who manages a biobank has a multitude of constant considerations to juggle. These can relate to consent management, ethics, legislation, resource constraints and balancing budgets. It’s not often you can pause to think about the fundamentals of what you are doing. To realign your daily work to the principles on which your biobank was founded. Are enough of your samples being released to researchers or are they just sitting in your freezers? Is it time to step back and ask yourself if you’re biobanking or bio-hoarding? What is biobanking for? This sounds like such an obvious question but it’s so important to pause to consider it whenever you get the chance. You are involved at the leading edge of medical research with the aim of improving outcomes for patients. Helping to improve lives and save lives. That’s a pretty sobering thought. You are a key link in a resource chain that connects generous donors with researchers, with the aim of furthering medical science. And there are two […]

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Building successful partnerships between funders and researchers

Gary Rooksby — Thu, 18 Jun 2020 08:55:35 +0000

No matter how large or small, no funder has unlimited finances. All funders have specific aims that they want to target to the best of their ability using their limited funds. This is true for large government funding bodies but especially true for small charities. You need to be fully aware of those aims and be constantly reviewing your work to ensure that it’s aligned. That’s how you, and by association, the funders gain the maximum “bang for your buck”. So, how do you ensure that both funder and researcher get what they need from the relationship? In short, it’s all about building a successful partnership between the funder and you, the researcher. The importance of keeping in touch in funder and researcher partnerships Right off the bat you need to keep in mind that all funded research is a partnership. Your research is targeted at furthering the aims of the funder. These aims, particularly for medical charities, are invariably geared towards improving treatments for patients. Each charity will have its own specific target group and those are typically patients. That means that your research will have three beneficiaries. Therefore, your partnership has three stakeholders and communication between all 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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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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