Importance of LIMS for Biobanks Any entity that stores biological samples can be called a Biobank. However, the term ‘Biobank’ is most commonly used for entities that store biological specimens on a large scale to provide them as a service for internal or external entities like researchers. Biobanks have to offer unbiased and high-quality samples using well-designed and documented procedures. This ensures a biological specimen is kept in a controlled environment and guarantees the ethical aspect of sample collection.
What the New FDA Guidance for ICH GCP E6 R2 Means for Sponsors and CROs FDA Guidance for Good Clinical Practice (GCP) is an international quality standard defined by the International Council for Harmonization (ICH) that governs ethical and scientific considerations for designing, conducting, recording and reporting trials involving human subjects. Compliance with FDA Guidance for GCP in clinical trials helps to assure that the rights, well-being and safety of trial participants are protected and that the data generated in the trial is credible.
Commmon Causes of LIMS Implementation Failures Due to the complex processes and technologies utilized in labs, and the many different aspects of the enterprise that laboratory systems touch, success in laboratory information management system (LIMS) projects can be difficult to achieve.
Benefits and Best Practices for Integrating Laboratory Instruments with LIMS Due to technological advances in laboratory instruments and higher throughput processes, data volumes in modern analytical laboratories have increased dramatically over the last several decades. While this increased data volume presents the opportunity to improve innovation and enable timely and effective business decisions, it also presents significant data management and processing challenges. In order to meet the challenge of turning this data into knowledge, laboratories are looking to automate and integrate laboratory operations and processes as much as possible in order to provide digital continuity throughout the product lifecycle.
American Whistleblower, Test America, Hunters Point Shipyard Cover-up and Michael Madry A major cover-up of the Hunters Point shipyard was the falsification of asbestos tests by Test America formerly owned by H.I.G. Capital whose owners were also bundling money to Hillary Clinton. They fired Test America Quality Assurance Manager Michael Madry who blew the whistle. |