The Dangers of Relying Solely on General Guidelines to Perform Software Validation for FDA Compliance

February 18th, 2014 by

Software Validation ComplianceThe FDA has established, via the issuance of General Principles of Software Validation, far reaching and comprehensive validation requirements relating to all software utilized for “…design, [...] 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 FDA to document concerns discovered during inspections.

The 483 states that it “lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional [...] Read More