Science and technology are evolving at an unprecedented pace. Great care is called for when gathering requirements and making choices for scientific informatics and software needs. There are few more vexing challenges than inheriting a poorly performing and entrenched legacy enterprise IT environment riddled with data and process silos. The cost, politics, and persuasion needed for change can overwhelm those who haven’t been shown the true value and potential upside. [Read More]
Laboratory information security is not merely a question of who can access your systems. What you allow people to access once they are in matters just as much. LabLynx ELab LIMS software solutions offer robust controls over access to your lab’s sensitive data. User profiles with granular access privileges limit the information and processes your staff may access and minimize the impact of stolen passwords and other cyberattacks. [Read More]
A common difficulty in completing a LIMS implementation project on time and on a budget is scope creep. Avoiding scope creep is every project manager’s dream, although it is close to impossible unless the initial scope is given the appropriate amount of care. Assigning a dedicated project manager can help, because the project manager commits to and must defend the original scope. It’s important to develop a scope that is as thorough as possible from the outset. [Read More]
Thermo Scientific™ SampleManager™ LIMS software introduces HL7 messaging enhancements – part of a suite of product functionality updates in SampleManager LIMS software v21.1 – offering clinical customers an improved scientific experience, with the uncompromising power and flexibility to meet the diverse needs of the clinical laboratory. The software is providing technologists with the ease-of-use software they deserve. [Read More]
Compliance with US FDA’s 21 CFR Part 11 Regulations is very critical for medical device and pharmaceutical companies. However, there are some grey areas that companies often face when they try to comply with 21 CFR Part 11. There is a common opinion or perception that we have seen where many companies think they are complying (often due to misunderstanding the requirements), but in reality, they are not. [Read More]
In this 2021 paper publisher in the journal Química Nova, Miguel et al. present the ISO/IEC 17025 standard in a historical context, while also providing some additional details about the concepts the standard proposes. As a quality management standard that also addresses competence, impartiality, and consistent operations in the laboratory, the standard emphasizes the importance of well-planned quality assurance towards reliable and traceable laboratory results. After an introduction to the standard, the authors take an in-depth look at ISO/IEC 17025's history and what drove changes to the standard over time. The article then examines what the standard asks of laboratories, as well as what value it adds to those labs. "By enacting ISO/IEC 17025," the authors conclude, "testing and calibration laboratories demonstrate they are responsible with their activities and their impacts, and put quality management and metrological traceability at the forefront of their operations."