Labs still face persistent Computer System Validation (CSV) challenges. In 2015, key issues included systems that didn’t function as intended, lacked 21 CFR Part 11 compliance, or missed basic CSV requirements. These concerns remain, but the landscape is more complex with growing data integrity demands, cloud solutions, automation, AI, and cybersecurity threats. Today, software configuration alone often falls short, making strong standard operating procedures (SOPs) essential for bridging validation gaps. [Read More]

Labs often lose critical data without realizing it—through inconsistent documentation, manual errors, or fragmented systems. Electronic Laboratory Notebooks (ELNs) act as silent guardians, capturing every detail in real time, ensuring data integrity, and providing a comprehensive audit trail. By integrating ELNs, labs can prevent data loss, enhance compliance, and streamline operations, turning potential chaos into clarity. [Read More]

Many laboratories are certified to the NELAC Institute’s (TNI) NELAP standards, which are based on ISO 17025 but tailored for environmental labs. Meeting these standards shows a commitment to quality through an accredited Quality Management System (QMS), offering a competitive edge and assuring reliable, reproducible testing data. LIMS play a key role in achieving and supporting these accreditations as the foundation of a lab’s QMS. [Read More]

Accurate environmental and water testing is critical for safeguarding public health, protecting ecosystems, and ensuring regulatory compliance. Laboratories face significant challenges in maintaining compliance with stringent standards set by agencies like the EPA, ISO 17025, and FDA. Manual processes and outdated systems often lead to inefficiencies, errors, and non-compliance risks. [Read More]

The selection of a lab informatics solution is among the most important decisions a lab can make, with significant implications for efficiency, productivity, and collaboration. In many ways, the lab informatics platform a laboratory selects will either enable or limit the type of lab it will become. [Read More]

Autoscribe Informatics, a Xybion company, is participating in London Lab Live 2025. Join us at ExCeL London from May 14 – 15, 2025, where we will be showcasing Xybion LIMS, our cutting-edge laboratory information management system (LIMS) designed to drive efficiency, compliance and data management in laboratories. Visit us at Booth #211 to discover the latest innovations in laboratory informatics and workflow optimization. [Read More]

Electronic Laboratory Notebooks (ELNs) transform how research teams manage data, ensuring accuracy and compliance. With automated audit trails, secure electronic signatures, and real-time collaboration, ELNs streamline grant reporting and simplify audits. By centralizing data and maintaining detailed records, they enhance transparency and save time—letting researchers focus more on innovation and less on paperwork. [Read More]