Few industries face record-keeping hurdles of the complexity and stringency faced by the Life Sciences industry. Their document lifecycle extends from the earliest stages of research and development to decades after the product is no longer marketed. All of this leads to hundreds of thousands – if not millions – of pages. How can a Life Sciences organization – including pharmaceutical, medical device and biotechnology organizations – overcome the hurdle of managing their content?
Overcoming internal hurdles and gaining efficiency
Time lost in the preparation of regulatory content can represent lost revenue. As a result, the importance of electronic submission-ready content is becoming more commonplace with the U.S. Food and Drug Administration (FDA) and regulatory agencies around the world— such as the European Medicines Agency (EMA)—pressing forward requirements for electronic submission.
Automating document processes offers efficiencies that are a significant benefit to all involved. However, gaining these efficiencies can be both a business and technological challenge. Standing in the way are information silos, heterogeneous systems creating source materials in various formats, the varying and stringent compliance requirements of governing agencies, and the time and cost involved in major system overhauls.