Compliance with industry regulations is non-negotiable in the fast-paced and highly regulated realm of life sciences. Navigating the intricate web of rules and standards is essential to ensure product and service safety, efficacy, and quality. This blog seeks to unravel the complexities of compliance regulations in the life science sector, providing a comprehensive understanding for professionals and organizations operating within this dynamic field.
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As consumers, we have a habit of purchasing products with features that fix the symptoms we are experiencing – an approach that often impacts our business choices too. But when it comes to solving laboratory challenges, we need to fully understanding the problem we’re trying to solve and the opportunities we want to harness. Key to this is answering the ‘why’ questions.
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Like other materials testing labs, construction and engineering laboratories have standards and regulations that affect their activities, though these are heterogeneous due to differences across local, state, and national accrediting/regulating bodies. These regulations and guidelines mandate a certain level of quality and safety in whatever is getting constructed, as well as where it’s getting constructed.
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The FDA’s Case for Quality initiative seeks to shift the focus from validation as a check-the-box regulatory activity to one that centers around quality. The shift will ensure that patients and end users have access to safe, effective care. The FDA issued the Computer Software Assurance (CSA) draft guidance in September 2022 to make validation of regulated systems less burdensome and more strategic. This blog will look at what we know about CSA—the good news is that our clients shouldn’t notice many changes in our validation approach.
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The types of testing found in a food and beverage laboratory can be quite diverse depending on the role the laboratory plays within the industry. Together, these labs and their strict test methods serve the populace by better ensuring the safety and security of the foods, beverages, and ingredients we depend on.
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As laboratories continue to grapple with an increasing volume of data, implementing a solution becomes a necessity. LIMS is a solution designed to help laboratories manage their data effectively. With the increasing volume of data generated in labs, LIMS offers advanced features to streamline workflows and improve data accuracy. From sample collection to analysis, LIMS ensures seamless integration of data across the entire laboratory workflow. In this blog article, we will examine how LIMS optimises data management in laboratories.
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Establishing collection and sample management protocols for pervasive per- and polyfluoroalkyl substances (PFAS) is time consuming and complex for laboratories worldwide. PFAS testing requirements and legislation are rapidly developing as scientists build a better understanding of the impact of these chemicals. And the pressure is on laboratories to meet these changing demands. So, why is PFAS testing on the rise and how can we support analytical testing laboratories in meeting this challenge?
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A LIMS for material testing labs manages samples, data, quality control, compliance, and more for ensuring high-quality, reliable results. Materials testing can involve a multitude of test methods defined by a variety of accreditation and regulatory requirements. This FAQ examines the LIMS functionality most valuable to a materials testing laboratory, including specialty functionality that not all LIMS vendors may provide.
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A LIMS for the food and beverage industry is important for meeting safety, quality, and compliance goals. Base functionalities include audit trails, document management, trend and control charting, non-conformance tracking and alerting. More specialized functionalities can include recipe and batch management, molecular biology workflows, on-demand environmental testing, and incident management.
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Eremid® Genomic Services, a specialty high-complexity CLIA-certified and CAP accredited genomics contract research organization (CRO), was in the process of streamlining their research and clinical laboratory workflows. The complexity and unique individual nature of their projects required a laboratory information management system (LIMS) that could support and manage the diverse portfolio of clinical and research-focused needs of their clients.
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Is your lab still trapped by Excel spreadsheets or clinging to outdated LIMS? It’s time to embrace the future. A new, upgraded LIMS is the key to a tomorrow-ready lab. With the latest features at your disposal, it’s a game-changer that can skyrocket your lab’s operational efficiency. Say goodbye to rigid processes and hello to flexibility, saving significant time and money while achieving your lab’s specific goals. [Read More]
There is no denying that technology is continually advancing. This will affect the scope of clinical research in 2024. While we learn to adapt and implement these technologies in our everyday lives, the clinical research field is working to capitalize upon these advancements for optimal benefits. Technology trends in clinical research continue to evolve at a very fast pace. Over the last decade we have seen a movement towards cloud computing which has resulted in the pervasive deployment of decentralized clinical trials.
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Transitioning to cloud architecture can offer a multitude of benefits to laboratory adopters. However, there are still significant questions to address and tangible deployment at scale has been rare. Cloud technology adoption is likely to be gradual, and yet it is only once laboratories deploy to the cloud that will they be able to realize the full potential of laboratory information system (LIS) or laboratory information management system (LIMS) software.
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In the constantly evolving world of laboratories, it is crucial to adapt to the future to maintain excellence. Laboratories that adopt Software as a Service (SaaS) LIMS are at the forefront of innovation. Unlike traditional on-premises installations, SaaS LIMS is a flexible solution that ensures laboratories remain future-proof. Let’s delve into the transformative capabilities of SaaS LIMS and explore how it revolutionizes the way labs operate and evolve.
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Accreditation to and compliance with ISO/IEC 17025 drive laboratory quality, which in turn better meets the requirements of the lab's customers. ISO/IEC 17025, and its quality focus throughout the lab’s workflow, provides tangible benefits by producing valuable analytical results that drive safer, more high-quality products and services, and improving costs, efficiencies, customer satisfaction, safety, and economic value.
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DNA, the code that governs all life on Earth, has fascinated scientists for decades. Next-generation sequencing (NGS) technologies have revolutionised genomics by enabling faster and more accurate reading of DNA. This has opened up new avenues for research and insights into the complexities encoded within our genes. This is where the indispensable role of Laboratory Information Management Systems (LIMS) comes into play. Why do Next-Generation Genomics laboratories need LIMS?
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Labs that get accredited to Laboratory Accreditation for Analyses of Foods (LAAF) need to demonstrate ISO/IEC 17025 compliance to food and beverage test methods and specific LAAF requirements. This requires a well-designed LIMS that can address the needs of ISO/IEC 17025 and the requirements LAAF places on the lab for LAAF accreditation.
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This white paper provides a comprehensive guide to validating your electronic learning management system (LMS). It explains what LMS validation involves, why it's important for regulated industries, and how the process addresses three main challenges.
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Materials testing and the standardized test methods are as diverse as the material types and industrial applications of those material types. These standard test methods are created by numerous national and international entities and adopted by accrediting organizations, regulatory bodies, and the materials testing labs themselves. Materials testing labs should understand how these regulations drive business and testing demand.
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Maintaining compliance to standards like ISO 22000 and ISO/IEC 17025 for food and beverage labs drives the need for an informatics tool such as a LIMS. Large amounts of data and information need to be captured by the LIMS, which can better empower the food and beverage company (and its laboratory) to comply with and gain insight from regulations and standards affecting their activity.
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