CONTENT MANAGEMENT
The FDA wants to achieve paperless submissions. To this effect the scope of Part 11 indicates the agency's intent to consider, “… Electronic records, electronic signatures and handwritten signatures executed to electronic records to be trustworthy, reliable and generally equivalent to paper records and handwritten signatures executed on paper.”

A CEO of a major pharmaceutical company is believed to have said, “ In this industry we make two products: drugs and documents – unfortunately, the authorities are only interested in the documents” . Its veracity may be questionable, but its implication is not.

Annual expenditure on research and development is growing by billions year on year, yet the number of new products being launched year on year is declining proportionally. Companies and investors are beginning to look anxiously at their pipelines. Drug companies, who in the past expected to have several clear years of unfettered monopoly with their therapeutics, are now finding their patents expiring earlier. Documents are everywhere. The industry saw the potential for managing all the intellectual capital tied up in the submission process – automating it, leveraging it, reusing it and publishing it – in order to reduce the time of the new drug approval (NDA) process. Document management became a common tool for doing just that. Most of the major players in the industry have implemented some form of document management system over the last 10 years to help them manage all the unstructured content in their R&D and regulatory affairs departments. Organizations like Roche have been saving millions of dollars by getting their submissions into the agencies more quickly, doing simultaneous submissions across the globe and re-using the content, where appropriate, from one regional submission to another or even from one drug to another. This approach has given organizations earlier approval for their drugs therefore more selling time before the patent expires and the inevitable arrival of the generics. At the same time many organizations have been looking at how they can optimize their supply chains internally, deal more effectively with their customers and suppliers and use technology to a greater extent across the drug phases. This has led to a massive investment in enterprise resource planning applications, customer relationship management and other similar applications. Content management needs to be at the heart of all enterprise applications required to deal with any unstructured content.

Requirements, features and processes of a content management solution >

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