ARTICLES BY ERIKA L. ROBERTS
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![Cyber Alert GettyImages-1185282377]( "FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions")
4/11/2024The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.
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![QA-Quality Assurance-GettyImages-1184320070]( "Enhancing Clinical Trial Efficiency & Compliance With eQMS")
1/10/2024In recent years, electronic quality management systems (eQMS) have emerged as powerful tools to streamline and enhance the quality control processes in clinical trials. This article explores the key components, benefits, challenges, and future of eQMS in the context of clinical trials.
Erika L. Roberts
Erika L. Roberts, MFS, is principal consultant and owner of ELR Lab Services LLC. Having more than 15 years of experience working in many different areas of the pharmaceutical/biotech manufacturing quality environments, she has particular expertise in sterility testing, microbial identification training, HPLC analysis, cGMP training, analytical chemistry, and pharmaceutical regulations. Roberts obtained a master’s in forensic science in 2006 with an emphasis in document examination.