Leveraging the NIST Cybersecurity Framework

As a validation engineer, why should you be concerned about Cybersecurity?  Good question!  Today’s headlines are filled with instances of cyber attacks and data breaches impacting some of the largest corporate systems around.  As validation engineers, our job is to confirm software quality and that systems meet their intended use.  How can you realistically do […]

Electronics Records Management For Validated Systems

The 21 CFR Part 11 Electronic Records; Electronic signature final rule has been effective since August 1998.  While much attention has been given to the electronic signature technical controls included within the final rule, less attention has been focused on the electronic records component.  Before we continue with this discussion, it is important to establish […]