The Company Core Data Sheet (CDS or CCDS) is one of the most important documents a pharmaceutical company creates. The CDS is a working document that contains information about the pharmaceutical product. It includes information from multiple sources, such as clinical trial data systems, clinical report documents, CMC data systems,
After decades (literally) of talking about silos, calmly and not so calmly explaining to people why they are problematic, and advocating for their demise, I have come to the (obvious) conclusion that we are not going to eliminate them any time soon. If you already figured this out, you are
In this white paper, you will learn what content standards are and why they are important. We introduce the Five Dimensions of Content Standardization™ and show you how our content standardization framework makes content FAIR (findable, accessible, interoperable, and reusable). Finally, we suggest some next steps that you can take
EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746) went into effect in May 2021, after about a year’s delay due to COVID-19. Medical device manufacturers have known about the new regulations for years and have been working to meet these new, more stringent standards.
I’ve started to notice a trend in structured authoring. In the past, almost all of our customers who implemented structured authoring were established companies with a lot of legacy content. And most of the writers were very technical. Rarely did I see young companies implement structured authoring from the beginning.
You manage a team of content creators and you’ve decided to embrace structured authoring. Congratulations! Perhaps you’ve heard that a structured environment will help your team create content that is consistent, modular, and reusable.
Organize and classify your content to make it more findable, and usable by implementing different layers of taxonomy in your CMS to build meaningful relationships and connections between your content.
Find out why moving from unstructured authoring to structured authoring and using a CCMS is very similar to learning how to cook a meal using an Instant Pot – and learn the secret to being successful when you do.