First FDA Audit at AIT Bioscience Using Fully Electronic Records
October 26, 2015 – Indianapolis – The FDA conducted a directed and general surveillance audit at AIT Bioscience, LLC on August 3-7, 2015. The audit covered method validation and LC-MS/MS and ligand binding assay studies. At conclusion of the audit, the inspectors made two facility observations during this first time inspection at AIT Bioscience. As we have seen during other audits, the AIT Bioscience electronic laboratory notebook system allowed auditors to access data quickly. A strong validation package, good audit trails, and the hierarchical design of the system supported quick access to the needed information and enabled audit questions to be answered and resolved promptly.
AIT Bioscience is committed to delivering strong scientific consultation and bioanalysis via a validated, comprehensive and fully-integrated electronic laboratory notebook (ELN) that easily accommodates both regulated and non-regulated work. For clients, this provides confidence that error prevention or correction is incorporated in real time during the conduct of studies, delivering rigorous data and results. These are delivered along with automation efficiencies, timeline improvements and effective audit processes.
About AIT Bioscience, LLC
AIT Bioscience, LLC, headquartered in Indianapolis, Indiana, is an integrated contract research laboratory (CRO) supported by a state-of-the-art, smart, electronic laboratory environment. This allows AIT Bioscience to devise the best solution for its clients, across each of its bioanalytical service areas. AIT Bioscience delivers robust analytical methods, highly-skilled and experienced client consultation, efficient sample logistics and rapid sample analysis from pre-IND through investigational new drug (IND), new drug application (NDA), abbreviated new drug application (ANDA) and Biologics License Application (BLA). For more information, visit www.aitbioscience.com.