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10 CAPA Tips for the Medical Device Industry

January 27th, 2016 by

Male Scientist Using Medical ToolsThe CAPA process from the side of regulatory compliance of both U.S. FDA requirements (21 CFR 820.100) and EU regulatory requirements ([...] Read More

How to Avoid Pharmaceutical Data Integrity Issues

January 22nd, 2016 by

Pharmacists in LabIn 2015, the US Food and Drug Administration (USFDA) issued Warning Letters to eight pharmaceutical companies for the lack of data integrity. According to the USFDA, data integrity means, “presence of accurate and reliable data in an application submitted to the [...] Read More