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In 21 CFR Part 11, the Food and Drug Administration (FDA) establishes its requirements for electronic records and signatures. These regulations, which apply to all or any FDA program areas, were intended to allow the widest possible use of electronic technology, compatible with FDA's responsibility to guard the general public health.   The DocuSign Agreement Cloud is employed by pharmaceutical and medical device companies to satisfy a variety of compliance requirements, including those set forth within the Code of Federal Regulations Title 21 Part 11.   We have an entire guide to CFR Part 11 and electronic signatures with samples of how DocuSign solutions satisfy requirements.   Here we’ll summarize subpart C of CFR Title 21 Part 11, which outlines requirements associated with the utilization of electronic signatures.   What is 21 CFR Part 11? Title 21 CFR Part 11 is that the a part of Title 21 of the Code of Federal Regulations that establishes th...

 Here you are, looking for an eLearning platform that is a perfect match for your SCORM content. Forveryone who has been into eLearning for a while, the search term “scorm compliance” seems to pop everywhere. Still, it’s easy to run into a solution that doesn’t support it.   In this blog post, we’ll guide you through some SCORM technical refinements and provide you with a checklist for making a smart choice in an LMS.   SCORM Explained Shareable Content Object Reference Model, or simply SCORM, is the gold standard for e-courses. Thanks to it, a SCORM compliant LMS runs any SCORM file just like a DVD player plays any DVD disc. So, if a company uses this format and decides to switch to another learning platform, there’s no need to worry about losing any content, as any other SCORM compatible LMS will recognize it too.   What does a SCORM course look like? For an LMS admin, a typical SCORM-compliant course looks like a ZIP archive. This archive contains ...

 What is performance management ? We talked to many HRs in our day to day who do not know very well the definition that definition or confuse performance management with performance evaluation .   Herman Aguinis, one of the greatest academics in organizational/industrial psychology, whose books are required reading for any HR professional who is serious about the topic, defines performance management as “the ongoing process of identifying, measuring and developing the performance of individuals and teams, and the alignment of this performance with the organization's strategic objectives” (Aguinis, 2009).   To manage is to measure and improve or measure to improve. Vicente Falconi defines management as “solving problems”. In both cases, performance management (we use performance and performance interchangeably) can be further defined as measuring and improving performance, or solving performance problems.   In any case, it is clear that within performance ...