Articles, News & Events

Laboratories are the backbone of clinical diagnostics, influencing millions of healthcare decisions every year. In such a critical role, even small errors in testing can have serious consequences. That’s why the U.S. federal government enforces the Clinical Laboratory Improvement Amendments (CLIA), a comprehensive set of standards to ensure quality and reliability in all laboratory testing performed on human specimens. Whether…

For laboratories supporting product development, quality control, or regulatory testing in industries like pharmaceuticals, biotechnology, medical devices, and cosmetics, Good Manufacturing Practice (GMP) is not just a guideline—it’s a legal and operational imperative. GMP ensures that every product leaving your facility meets the highest standards of quality, consistency, and safety. Without it, even the most scientifically sound processes can lead…

In highly regulated industries, trust in scientific data is non-negotiable. Whether it’s a pharmaceutical company submitting results to the FDA or a chemical manufacturer preparing safety studies for regulatory review, data must be credible, reproducible, and traceable. That’s why Good Laboratory Practice (GLP) exists—establishing a global standard for the quality and integrity of non-clinical laboratory studies. For laboratories involved in…

In regulated laboratory environments, maintaining the integrity, security, and traceability of electronic records is essential—not only for operational excellence but for legal compliance. That’s where 21 CFR Part 11 comes in. Enforced by the U.S. Food and Drug Administration (FDA), this regulation defines how electronic records and electronic signatures must be managed to be considered as trustworthy and reliable as…

Protecting patient information is more than just a regulatory checkbox for laboratories—it’s a fundamental responsibility. Laboratories that manage patient data are required to comply with HIPAA (Health Insurance Portability and Accountability Act) regulations to ensure sensitive health information remains private and secure. Whether your lab performs diagnostic testing, integrates with electronic health systems, or shares results with providers, HIPAA compliance…

In the fast-paced world of laboratory operations, experience is not just an advantage—it is essential. With over 25 years of lab management experience, LabLynx stands as a proven partner for laboratories seeking more than just software. We provide long-term solutions, industry insights, and the kind of real-world understanding that only comes from decades of working side by side with labs…

TNI/NELAP Accreditation has become a defining benchmark for laboratories that aim to maintain the highest standards of environmental testing, quality assurance, and regulatory compliance. In today’s increasingly regulated and data-driven world, laboratories across the United States are under mounting pressure to demonstrate not only technical competency but also a robust commitment to traceability, defensibility, and transparency. This is where TNI/NELAP…

For laboratories serving the food and beverage industry, HACCP compliance is more than just a regulatory requirement—it’s a vital commitment to public health and consumer trust. HACCP (Hazard Analysis and Critical Control Points) is a globally recognized, science-based system used to identify, evaluate, and control food safety hazards. While much of the HACCP process takes place on the production floor,…

Today’s laboratories generate more data than ever before—but the true value of that data depends on how well it is managed, interpreted, and applied. That’s where laboratory informatics comes in. As the backbone of digital transformation in the lab, laboratory informatics connects people, instruments, and processes in real time to accelerate discovery, improve quality, and ensure compliance. From life sciences…

In today’s global food economy, safety isn’t just expected—it’s essential. From raw materials and packaging to production, testing, and transport, every point in the food supply chain must meet strict quality and safety standards. That’s where ISO 22000 comes in. ISO 22000 is the internationally recognized standard for food safety management systems (FSMS). Developed by the International Organization for Standardization…