by Walter Nowocin
There are many regulatory requirements that bio-medical companies need to follow; however, FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures is one of the more obscure and misunderstood of the compliance regulations. In this article, we will review the background and content of FDA 21 CFR Part 11. We will highlight the three most important aspects of the document and then reveal the hidden value of FDA 21 CFR Part 11 for computer software applications.
