Data Fabric is a hot topic buzzword today. We think of Data Fabric as the way of creating an abstraction from the underlying technology. Allowing the data to be exposed at the top level as business objects that are semantically related. This can be thought of as a weaving together of data from internal silos and external sources that creates a network of information to power the business’ applications, AI, and analytics.
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Electronic Laboratory Notebook (ELN) plays a vital role in the laboratories in the areas of bench level analysis, and point of analysis by providing real-time automation and control of testing procedures. Cloud-based ELNs ensure that procedures are carried out in an automated manner by the way direct integration with instruments (i.e. data is collected directly from instruments), the computations are performed, and inventory is checked and updated.
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Develop Effective Training for your Pharmacovigilance System. Conduct it Early. Employee participation in training–prior to go-live of your Pharmacovigilance System–is critical to enhancing comfort key to realizing the full benefit of a new software system. Software training for your pharmacovigilance system is most effective when it is focused on the end-user position.
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Day-to-day lab operations rely on workflows to manage people, tasks, and systems so that work follows a consistent process every time. Defined workflows help ensure that all the steps are done in the correct order, are free from errors, and meet regulatory requirements.
But, representing lab workflows can be difficult.
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From a customer’s order to the final report, laboratory errors can appear at any time in the total testing process. As our in-depth guide “
Improve Laboratory Accuracy and Reporting Quality with a LIMS” explains, you can prevent these types of laboratory errors by digitizing laboratory processes. Many sources of error are human, and it’s only a matter of when, and how often, people make mistakes. Let’s look at how a
laboratory information management system (LIMS) from LabLynx reduces human error by automating manual activity throughout the total testing process.
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GxP is a set of regulations and quality guidelines formulated to ensure the safety of life sciences products while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution. The GxP standards were established by the
Food and Drug Administration for a range of compliance related activities.
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An effective data migration plan ensures your data is accurate and thorough during the critical transfer phase from the source platform to the destination platform. Once your team is assembled, it is crucial that they focus first on mapping, selecting, preparing, extracting, transforming, and transferring to the new system data that’s of the proper form and quality.
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Earlier this year, ApolloLIMS and
HORIZON Lab Systems were acquired by CliniSys Group to grow the organization’s community and public health diagnostics capability.
CliniSys is one of the largest providers of laboratory information systems (LIS), order entry and result consultation, and public health solutions in disease surveillance and outbreak management across the United Kingdom, Europe, and United States.
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Does your LabWare implementation connect to external applications, such as SAP, another LIMS solution, or an external database? Are there multiple interfaces between LabWare and those external applications? If so, your
LabWare implementation will greatly benefit from the Message Engine Template, as it is LabWare’s standardized and validated way to connect with external systems. In this post, we’ll learn about how LabWare’s Message Engine works...
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Errors may appear at any point in the laboratory workflow, from sample preparation and test setup to instrument calibration and report creation. Inaccuracies lengthen turnaround times, reduce efficiency, and potentially lead customers to poor decisions based on incorrect or missing data. Using a laboratory information management system (LIMS) to constrain sources of pre-analytical, analytical, and post-analytical errors offers benefits beyond just improving test accuracy.
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I love the work of change management because it is messy, unpredictable, and deeply personal. Humans, when taken individually, are complex and full of surprises. But aggregate the expected behavior of 10, 50, or even 10,000 humans and the possible outcomes are practically limitless. I have yet to experience a boring day on a change management project and I don’t expect to live through one any time soon.
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Data integrity, an area of increasing priority in today’s laboratory world and “The focus area” when it comes to regulatory compliance such as 21 CFR Part 11 and Eudralex Annex 11. Considering the number of warning letters from US FDA and other such regulatory bodies issued to pharmaceutical and medical devices manufacturers across the globe, Data integrity is the “Buzz word” in today’s audit.
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Human resources have always been a critical function in any company. But with the digital age, the future or human resources is becoming an even more essential component of business success. To stay ahead of the curve, HR must undergo a digital transformation. This means deploying digital platforms for employee engagement, introducing personalized training and skilling programs, and using automation and analytics for insights and efficiency.
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ELN is developed to replace paper notebooks so that scientists and researchers can record and search their records much more easily and archive their data onto another electronic device. An ELN allows lab professionals to access, share, and analyze data using a computerized system. ELN software is an advanced application that allows lab professionals to maintain critical experimental information in digital form, making it easily retrievable, more secured, and reusable for future experimental needs instead of adopting outdated and manual approaches.
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Managing your clinical diagnostic laboratory’s information has become as important as managing the laboratory itself. More data-intensive technologies, more comprehensive regulatory compliance, and other trends require an effective
laboratory information management system (LIMS) to effectively manage all that data. Turning to an effective vendor selection process is among the most important of those lessons. Naturally, we think
LabLynx should top your list! But how do you truly know a vendor is a good match? These seven steps will help you find the right LIMS for your laboratory.
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Day-to-day lab operations rely on workflows to manage people, tasks, and systems so that work follows a consistent process every time. Defined workflows help ensure that all the steps are done in the correct order, are free from errors, and meet regulatory requirements.
But, representing lab workflows can be difficult.
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COVID cases have
re-surged this summer in many regions of the US. New omicron variants are largely the cause of new waves of infection, fueled by increased summer travel and relaxed mask requirements. “Customers are telling us they’ve been ramping back up since May 2022 to handle more COVID testing,” says Robert Benz, marketing manager for HORIZON, now also part of Clinisys. The CDC
COVID data tracker shows a steady rise in reported cases starting in the middle of March 2022.
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Yes, shelling out money for a third-party consultancy may seem counterintuitive when you’re contemplating making a big investment in a laboratory informatics management system (LIMS). However, the value companies gain by working with a LIMS consultancy provides multiple dividends. As laboratory staff, you are the expert in your research field, and no one expects you to also understand the intricacies of deploying a LIMS; that’s why consultancies exist. LIMS implementations are our specialty and we’re here to help.
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Contract and development manufacturing organizations (CDMOs) are a major resource in pharmaceutical & biotech product development, not only for smaller companies lacking research and manufacturing facilities but also for large organizations needing specific expertise. Lab information management systems (LIMS) are a key element in successful CDMOs, helping them transition to Industry 4.0 during the research and development phase, with synergies that even ease the path to manufacturing.
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Selecting a new pharmacovigilance system is a big decision that the company will have to live with for many years into the future. At Astrix, we advise our clients and assist in leading the process of selecting a new system which also involves organizational change management. A critical aspect to any change like this is to ensure that there is a strong alignment with the leadership team and everyone involved in the selection process. That cohesion is imperative.
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