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DIA 2015 – Day One Recap

June 15, 2015

Even though my flight from Chicago was delayed (given the severe storms there all day, I was lucky to even get out at all), I managed to see one great session and have some wonderful conversations in the networking breaks and on the expo floor at DIA today.

The two topics I was most excited about were continuous process improvement and enterprise document management strategy.

The first came up in the 11 am session, with Michelle Charles from Merck and Chris Hanna from Kattner-Thalmann. They both spoke to continuous improvement (CI) and Lean Six Sigma efforts in reg ops–Chris from the professional services, more theoretical angle, Michelle from the been there, done that angle of finishing a CI project at Merck in 6 months. And although the net net wasn’t anything earth shaking in terms of CI, for the Life Sciences industry, which has traditionally been way way behind other manufacturing verticals, it was a big plus to see a culture shift regarding process improvement. And it’s always great to hear what a real person at a real company is doing about a critical challenge like CI (thanks, Michelle)…

Enterprise document strategy wasn’t the subject of any given session, but rather the topic of conversations  in the vendor expo and at networking breaks throughout the day. And in this regard what I heard was that, despite a decade or more of work on functionally based document management strategy, very few organizations were approaching document management strategy from a cross functional, truly enterprise perspective, i.e., across the value chain from R&D and clinical, to regulatory, QA, maufacturing, and commercial, PV, and medical affairs. But despite that lack of enterprise perspective, most firms truly needed that enterprise perspective to solve their many, significant business challenges relating to document management.

The negative effects of the lack of document mangement strategy that folks described were striking: low adoption of exepensive, resource intensive document management systems, extreme end user disatisfaction with document management tools, process inefficiencies, increased compliance costs and risks, impaired executive decision making, higher portfolio risk, etc.

Other than “getting a great enterprise wide strategy”, no quick answers to the problem. But I’m grateful for the opportunity to engage folks in great conversation and learn more about what’s going on in the industry.

I look forward to what DIA 2015 day two brings!

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