Data Not Documents

Ever since moving to word processing, the pharmaceutical industry has relied on unstructured authoring environments such as Microsoft Word to create submission content. For decades, pharma has used a combination of MS Word and file storage (such as SharePoint) to author, manage, store, and publish content destined for regulatory agencies. Content that emanates from MS Word, Google Docs, and other unstructured paradigms is, by definition, worked on in documents. The document is the “unit” of content. Documents, by their very nature, have certain characteristics, features, and drawbacks.