Computer System Assurance – The Digital Era of FDA Compliance

Nearly a quarter of a century has passed since the U.S. Food and Drug Administration (FDA) established regulations on electronic records and electronic signatures, commonly known as 21 CFR Part 11, under which they are considered trustworthy, reliable and equivalent to the traditional paper records. The regulations provide guidance for organizations that maintain records or submit designated information electronically to the FDA, requiring computer system validation, audit trails, and record retention guidelines necessary for regulatory compliance.

While these regulations remain in effect, the informatics landscape has progressed and evolved significantly beyond the scope and intentions of the current code. The emergence of cloud based computing, artificial intelligence (AI), machine learning (ML) applications and SMART technology necessitate a paradigm shift in the current approach to computer system validation.

To read more, please download this free white paper.