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class="entry-title">Navigating Data Integrity in Bioanalytical Labs</h1> <span class="post-info-author"> By <a href="https://www.thermofisher.com/blog/connectedlab/tf-author/sarah-yesford/" title="Posts by Sarah Yesford" rel="author">Sarah Yesford, Product Marketing Manager</a> </span> <span class="post-info-date"> 11.29.2023 </span> </header><div class="entry-content"><p><img decoding="async" class="alignnone size-large wp-image-2857" src="https://www.thermofisher.com/blog/connectedlab/wp-content/uploads/sites/14/2023/11/Data-integrity-in-bioanalytical-labs-1024x674.jpeg" alt="Young scientists conducting research investigations in a medical laboratory, a researcher in the foreground is using a microscope" width="760" height="500" srcset="https://www.thermofisher.com/blog/connectedlab/wp-content/uploads/sites/14/2023/11/Data-integrity-in-bioanalytical-labs-1024x674.jpeg 1024w, https://www.thermofisher.com/blog/connectedlab/wp-content/uploads/sites/14/2023/11/Data-integrity-in-bioanalytical-labs-300x197.jpeg 300w, https://www.thermofisher.com/blog/connectedlab/wp-content/uploads/sites/14/2023/11/Data-integrity-in-bioanalytical-labs-768x505.jpeg 768w, https://www.thermofisher.com/blog/connectedlab/wp-content/uploads/sites/14/2023/11/Data-integrity-in-bioanalytical-labs-1536x1011.jpeg 1536w, https://www.thermofisher.com/blog/connectedlab/wp-content/uploads/sites/14/2023/11/Data-integrity-in-bioanalytical-labs-2048x1348.jpeg 2048w" sizes="(max-width: 760px) 100vw, 760px" /></p> <p>In the rapidly evolving landscape of bioanalysis, the challenge of maintaining data integrity has never been more critical. With a surge in sophisticated scientific modalities like monoclonal antibodies and next-generation cell therapies, bioanalysis is transforming at an extraordinary pace. This blog delves into the complexities and nuances of ensuring data integrity in bioanalysis, a theme central to our recent whitepaper, <a href="https://assets.thermofisher.com/TFS-Assets/DSD/brochures/Thermo_Enabling_Data_Integrity_Whitepaper_EN_1123.pdf" target="_blank" rel="noopener">Enabling Data Integrity in Bioanalysis</a>.</p> <p>The expansion of large molecule development and the intricate nature of small molecule bioanalysis demand a higher level of sensitivity and specificity. Techniques such as liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS) are pivotal in detecting lower analyte concentrations in complex biological matrices. Moreover, the integration of high-throughput automation systems is revolutionizing how samples are handled, reducing errors, and enhancing laboratory productivity. Our partnership with customers focuses on tackling these specificity and sensitivity challenges head-on.</p> <h4>The importance of quality and integrity in laboratory analysis</h4> <p>Data integrity extends beyond the lab bench. It encompasses record-keeping, sample shipping, stability, study management, and more. The quality of data from bioanalytical laboratories is crucial for regulatory submissions and phase 1-4 clinical trials; Inadequate documentation or non-compliance can lead to significant setbacks, including regulatory rejections and project delays. Therefore, adhering to regulatory standards is a daunting task for bioanalytical laboratories and many labs have turned to tools such as a LIMS to support their efforts.</p> <h4><strong>The high cost of non-compliance</strong></h4> <p>Non-compliance with FDA regulations can lead to substantial direct and indirect costs; from financial penalties to damaged public reputations, the consequences are far-reaching. Implementing <strong>a trusted Laboratory Information Management System (LIMS) that is used by regulatory bodies and pharmaceutical sponsors</strong> can mitigate these risks by supporting comprehensive data management and compliance with regulatory guidelines. A LIMS provides bioanalytical labs with a mechanism to ensure that their scientific data is captured, documented, stored, witnessed, and archived in a safe and secure manner.</p> <h4><strong>Maintaining analyte and sample integrity</strong></h4> <p>Ensuring the integrity of analytes and samples is a multifaceted process. It involves stringent control of the drug product from manufacturing, handling, shipping, and storage procedures. This includes tasks such as ensuring that the product certificate of analysis is attached to each analytical run and that the same lot of drug product is used from method development throughout sample analysis, providing consistency across data sets. Validation of computerized systems and laboratory equipment is essential for accurate and reliable data. Additionally, complete chain of custody for samples is critical to maintain credibility in bioanalytical studies, and this can be achieved with a LIMS.</p> <h4><strong>The role of LIMS</strong></h4> <p>The use of dedicated and proven bioanalytical LIMS, like <a href="https://www.thermofisher.com/uk/en/home/digital-solutions/lab-informatics/lab-information-management-systems-lims/solutions/watson.html" target="_blank" rel="noopener">Thermo Scientific™ Watson LIMS™ software</a>, is essential in supporting compliance and maintaining the integrity of data components. Watson LIMS software is designed to support the entire lifecycle of bioanalytical studies, supporting compliance with regulations such as GLP, 21 CFR Part 11, FDA Bioanalytical Method Validation, and EMA guidance documents. The software features a robust audit trail and sample chain of custody, providing a complete record of study activities. By emulating study and amendment protocols, Watson LIMS software ensures that all actions within the system align precisely with the study protocol.</p> <p>In addition, lab managers can easily implement and report on method validation parameters, such as precision, accuracy, matrix effect, recovery, selectivity, and stability, directly within the software. This streamlines the validation process and ensures accurate and reliable data analysis. The software also allows for the establishment of run acceptance criteria, flags for out-of-range results, re-assay procedures, and incurred sample reanalysis protocols, providing flexibility and control over data management and quality control processes.</p> <p>Watson LIMS software offers a trusted and comprehensive solution for managing bioanalytical studies, supporting compliance, and optimizing data management and analysis processes.</p> <h4><strong>Working with the world leader in serving science</strong></h4> <p>In the dynamic field of bioanalysis, we understand that leaving data quality to chance is not an option. Partnering with Thermo Fisher Scientific means you are accessing a team of experts with over two decades of experience serving the global bioanalytical community. Our range of software solutions to meet lab and data management challenges head-on, support regulatory compliance, and turn challenges into strengths. We provide comprehensive support, from integrating data analysis with Watson LIMS software to utilizing our state-of-the-art laboratory services. With Thermo Fisher, every aspect of bioanalysis is elevated to the highest standard. Our Watson LIMS software is a testament to our commitment to providing industry-trusted solutions. By leveraging our expertise, bioanalytical laboratories can navigate this complex landscape with confidence and precision.</p> <h4><strong>Read our whitepaper</strong></h4> <p>To dive deeper into these topics and explore our comprehensive solutions for bioanalytical challenges, check out our new whitepaper, <a href="https://assets.thermofisher.com/TFS-Assets/DSD/brochures/Thermo_Enabling_Data_Integrity_Whitepaper_EN_1123.pdf">Enabling Data Integrity in Bioanalysis</a>. Discover how Thermo Fisher can be your trusted partner in ensuring data integrity and compliance in the ever-evolving field of bioanalysis.</p> <p>Have any questions? <a href="https://www.thermofisher.com/uk/en/home/global/forms/digital-solutions/lims-demo-quote-request.html">Contact us</a> and we will be in touch.</p> <aside class="mashsb-container mashsb-main "><div class="mashsb_above_buttons">Share this article </div><div class="mashsb-box"><div class="mashsb-buttons"><a class="mashicon-facebook mash-large mashsb-noshadow" href="https://www.facebook.com/sharer.php?u=https%3A%2F%2Fwww.thermofisher.com%2Fblog%2Fconnectedlab%2Fnavigating-data-integrity-in-bioanalytical-labs%2F" target="_top" rel="nofollow"><span class="icon"></span><span class="text">Facebook</span></a><a class="mashicon-linkedin mash-large mashsb-noshadow" 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