Link: http://feedproxy.google.com/~r/BecauseProcessMatters/~3/bgXcI8saOK8/
Last week, OpenText participated in DIA’s EDM and ERS/eCTD conference in Baltimore and what a great event it was! This hybrid conference combined related disciplines to focus holistically on “The Content Continuum from Document Authoring through Submission Delivery” which proved to be highly informative. There were multiple presentations by FDA providing updates on the new Module 1 of the eCTD as well as regional updates including the Saudi Food and Drug Authority, Health Canada and others. In addition to discussions about submissions and the new eCTD v4, TMF was a key focus. With a highly interactive format, most of the sessions were actually lively discussions between industry, regulators and solution providers that benefited all parties.
For OpenText, this broad focus on content management within the highly regulated environment of Life Sciences is extremely apropos. Our strategy of Enterprise Information encompasses all of the required technology capabilities to author, review, approve and submit documents to the applicable health authorities. Hearing many of the challenges posed by audience members from industry also brought to light why technology solutions are so critical to this space. First and foremost, regulatory compliance is paramount. Even the most highly trained and experienced knowledge workers who develop regulatory submissions or even trial master files need help ensuring all content meets all regulations. Humans are fallible and often over-worked which is where technology comes into play. While compliance enforcement is well understood, in the ever-evolving area of eCTD, configuration and flexibility to change are more important than ever. As we learned in a track focused on the new eCTD v4 which is just around the corner, the requirements are changing (mostly for the better). However, the trickier part is that adoption of v4 will not happen in a clean cutover and companies will be forced to manage existing submissions in eCTD v3.2.2 and earlier while also submitting new ones in v4. This effectively means submission solutions must be flexible enough to support changes to the existing requirements and also manage those changes differently for different submissions. Clearly rigid technology is not going to fit the bill. OpenText ContentServer is purpose built for this challenge as it is a configuration-based application meaning changes are not custom-coded and thereby much easier to manage and maintain.
Beyond eCTD, the other glaring technological need is on the process side. While companies and regulators focus so heavily on the content itself and highly complex structure of the content, the processes by which these documents are created, referenced, stored, managed and approved is overlooked. This topic became apparent in several of the interactive sessions and it represents a significant compliance problem as processes almost always rely on content or generate content. Immediately, the power and applicability of OpenText’s Enterprise Content Management integration with Business Process Management came to mind. The combination of these two technology disciplines gives Life Sciences the ability to manage both process and content in context.
Lastly, everyone was talking about the cloud. While several audience members still voiced concerns about security, shared infrastructure and the like, it seems that these fears have been assuaged. Make no mistake about it, pharma is moving to the cloud in a big way. And not just in non-regulated spaces. What great timing for the OpenText cloud offerings which have catapulted OpenText to the lead of the movement to take enterprise applications and technologies to the cloud. Check out more here…
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