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The European Medical Device Directive As It Compares To 21 CFR 820

March 10th, 2014 by

FDA & EU Medical Device ComplianceThe European Medical Device Directive or 93/42/EEC regulates which medical devices may be sold in the European market, while [...] Read More

Why Is FDA 21 CFR Part 11 Compliance Important?

February 4th, 2014 by

Electronic RecordsComplying with Part 11 can be a difficult thing to do. This is in part due to the fact that FDA recalled all the guidances concerning the implement of Part 11 in September 2003. Companies have been left to their own means to interpret Part 11, since the FDA leaves the [...] Read More

Understanding How FDA Warning Letters Can Hinder Your Company

January 30th, 2014 by

FDA Warning LetterUnder the Federal Food, Drug and Cosmetic Act, SEC. 704 (21 USC §374) “Factory Inspection” the United States Food and Drug Administration (FDA) is authorized to perform inspections of US and foreign facilities. Form FDA 483 (Inspection Observations) is used by [...] Read More

FDA 21 CFR Compliance as a Gateway to Market Viability

January 27th, 2014 by

FDA 21 CFR RegulationBefore selling their products, firms have to ensure that they adhere to US and European government regulations. This is a job in and of itself; staff at all levels must maintain extensive conversance with a huge body of rules devised by the Food and Drug Administration [...] Read More

How to Ensure CSV Compliance For Your Software

January 27th, 2014 by

CSV ValidationCSV (Computer System Validation) compliance is something that the FDA and the European Regulatory Authorities take very seriously. Software programs that are not in compliance with validation and the associated infrastructure qualification measures could result in a product recall by the [...] Read More