About this Datasheet

The future of documents is shaped by a fundamental change in how information is shared. This future sees a shift from traditional »e-paper«, formatted and optimized for reading by humans, towards semantically tagged information in an open digital format. Regulatory submissions are still very much centered around »classic« documents: formatted PDFs. The common practice is to write in Word, and copy and paste data manually, then take a »picture« of that document by creating a PDF version which is submitted. This intrinsicallyposes risks of inconsistencies, and the inefficiency of the practice is increasingly problematic. While documents are accompanied by structured XML for key-data and meta-data, documents and data are still »separate worlds«. Structured content authoring has the potential to bridge them together. Structured documents are component-based, contain included data and are largely created automatically.

Business users need to have efficient and effective access to data and documents no matter where it originated or where it is finally stored, addressing Clinical, Regulatory or Quality needs. It is fundamental to not look at structured content authoring in an isolated way but to provide an integrated approach for end users, enabling access to all core functionality through their primary business application.

integration-center from fme provides a cloud-ready and preconfigured integration framework, allowing for faster and easier integration of implementations across all the major platforms, including Veeva Vault, OpenText Documentum, Generis CARA, and many others.