June 13, 2011

Why are most life science companies still using 1990s technology?

We recently compiled and analyzed the results from a survey aimed at understanding how life science organizations are managing core product development artifacts and proving traceability. The results showed that most are still using Microsoft Word and Excel to manage and trace artifacts—at best storing documents and artifacts in a document or quality management system. I wonder how these organizations manage to tie all the documents together and prove traceability with the FDA? The premarket submission process and proving verification and validation efforts are hot topics these days with the FDA, life sciences industry, and our U.S. Congress. Because these rulings and guidelines were first published in the 1980s and 1990s, part of the ongoing debate might be the overall confusion of how organizations should manage and trace artifacts. It's apparent that most organizations are using the literal definition of the word “document”, not the intended and redefined word meaning from the FDA. I believe the days of life science companies trying to stand behind reams of paper is about over with the FDA. The FDA’s intent is not to waste reams of paper just to record signatures in ink. Instead, the FDA merely seeks proof that good processes were followed and core product development artifacts are accountable and tracked. Most importantly, the FDA wants to ensure these artifacts are traced during the development phases, not created outside of development in a spreadsheet or only shared internally with management and the FDA. View the survey results.