Amplexor Life Sciences in Pharmaceutical Manufacturing

In aerospace engineering and industries like it, structured authoring of routine yet complex documents is accepted practice. Yet, up to now this approach has eluded life sciences.

In fields with complex information needs, such as engineering, use of structured authoring is second nature – particularly in regulated industries. Organizations spanning automotive, aerospace manufacturers and power utilities have teams of people routinely coordinating structured content, populating complex documents with approved information components.

In life sciences, the set-up has traditionally been quite different. Take the teams responsible for preparing regulatory content. As medical doctors, pharmacists and chemists by background, they have tended to favor office-style content tools, such as Microsoft Word, for generating documents. The downside of this practice is that, beyond manually cutting and pasting from existing documents, teams must largely start afresh each time a new or updated submission is needed — finding the right data all over again, and compiling it under the necessary headings.

A process that is at best inefficient, and at worst laden with risk of error.