September 13, 2017 - Data Integrity in FDA-Regulated Laboratories
Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. As such, the FDA’s expectation is that all data which is submitted to the Agency is both reliable and accurate...September 13, 2017 - Electronic laboratory notebooks in a public–private partnership
This report shares the experience during selection, implementation and maintenance phases of an electronic laboratory notebook (ELN) in a public–private partnership project and comments on users' feedback. In particular, we address which time constraints for roll-out of an ELN exist in granted projects and which benefits and/or restrictions come with out-of-the-box solutions. We discuss several options for the implementation of support functions and potential advantages of open-access solutions. Click Here to read the full journal articleSeptember 6, 2017 - Accelerating Clinical Research Using Cloud Technology
With the aim of helping individuals overcome health issues, clinical research is an important field where doctors, drug experts and biologists work together to unravel the causative factors and suitable treatment plans for the most critical health problems.September 5, 2017 - LIMS Upgrade Project – Letter to Self
It has been a long road but the LIMS upgrade is finally complete, up and running, and validated. As I look back on this journey, I wish that I knew then what I know now.August 21, 2017 - 3 Areas a LES Can Drive Cost Savings
A Laboratory Execution System (LES) can minimize costs while maximizing quality.August 9, 2017 - Electronic lab notebooks: Can they replace paper?
Despite the increasingly digital nature of society, there are some areas of research that remain firmly rooted in the past; in this case the laboratory notebook, the last remaining paper component of an experiment. Countless electronic laboratory notebooks (ELNs) have been created in an attempt to digitize record keeping processes in the lab, but none of them have become a "key player" in the ELN market, due to the many adoption barriers that have been identified in previous research and further explored in the user studies presented here.August 8, 2017 - Manage Testing and Laboratory Workflows with LIMS
CloudLIMS recenty hosted a live complimentary webinar on "Manage Testing and Laboratory Workflows with LIMS", presented by Mr. Rakhil Akkali, Product Analyst at CloudLIMS.com. The webinar provided insights on how a LIMS plays a pivotal role in automatic sample accessioning, sample tracking using barcodes, managing multi-analyte tests and test Chain of Custody (CoC), automated report generation, besides helping testing laboratories follow regulatory guidelines seamlessly.
To watch the video or to download the presentation slides, please visit the webinar section: https://cloudlims.com/resources/lims-webinar.jsp
August 4, 2017 - What the FDA’s Quality Metrics Reporting Program Means for Your Lab
Quality metrics are utilized throughout the pharmaceutical industry to assure product quality and facilitate continued improvement of drug manufacturing processes. The FDA has also shown a significant interest in quality metrics, as data detailing compliance with quality standards in drug manufacturing helps the FDA establish compliance and inspection policies, predict and potentially mitigate future drug shortages, and know how to support and encourage drug manufacturers to implement stat-of-the-art quality management systems.…





