[Also posted on LinkedIn Pulse]
I have just attended the 15th Drug Information Association (DIA) European Electronic Document Management conference in Berlin. Here are a few thoughts and observations that came to mind as I sat through some of the presentations:
Many speakers described issues relating to the conference theme of standardisation and how we could potentially improve interoperability and increase efficiency through use of technology. But it was refreshing to hear Russell Joyce (Heath Barrowcliff Consulting) talk about the importance of information governance…. a topic that is sadly missing from many people’s agendas.
We heard about functionality needed for regulatory submissions management but I really have to question the need for “archive and find” functionality for submissions. In general, submissions are a snapshot of source records…. the source should be stored and managed in their respective “system of truth”. Yes, we need to identify what goes into each submission and may have a need to go back and run queries several years after the event. But submissions are a published COPY of original records. So, ‘archive and find’ functionality is needed in the “systems of truth” i.e. for the source content. This is the content that needs archiving in compliance with relevant regulations….. the submissions can be destroyed as soon as there is no longer a business need for them (usually a relatively short period).
System implementation projects often take several years within our industry and so it was interesting to hear about a project that was delivered in just over 2 months. Impressive? Yes, but I just couldn’t help wondering the extent to which success was heavily dependent upon a team of external consultants (e.g. to rewrite applicable SOPs) and the fact that the system was implemented with “out of the box” functionality. It is not often projects are this straight-forward. Having said that, perhaps a prompt for us to think hard why our IT projects have to take quite so long? If we had to deliver in 3, 4 or 5 months, could we? I reckon we probably could!
Another presentation concerned a process harmonisation effort as part of an IT implementation project. It was interesting to see that a specific objective of the project was identification of activities that could be carried out externally by a vendor i.e. an assessment of core competencies to be retained in-house. Perhaps we need to be more open to out-sourcing activities that we “hold dear”?
Great presentation on digital preservation. Much more than electronic archiving. Every organisation needs a digital preservation plan….. not just a retention schedule that says we’ll archive the content electronically for 25 years.
It was interesting to hear that one of the over-riding principles when the Reference Models were initially established was that content taxonomy was not considered to provide any competitive advantage and hence, we could all share openly our practices and learn from each other. It got me thinking that perhaps recent GCP inspection experience suggests that NOT adopting a reference model increases the risk of inspection findings. On this basis, is content taxonomy now actually providing competitive advantage to those that adopt the reference models?
My final observation concerned some comments from one of the regulatory agencies who pointed out that our design and implementation of eTMF solutions should be based on our business needs and should facilitate trial conduct and management, rather than to please a GCP inspector….. a statement that I heartily agree with. It was therefore a little disconcerting to subsequently hear the same individual comment that our use of perhaps five distributed and varied IT solutions might result in an inability of the inspector to perform an inspection within the required timeframe and should therefore be avoided. I think there’s a disconnect here! If use of 5 disparate systems is chosen by the sponsor for sound business and quality reasons, the agencies need to adapt their inspection regime to accommodate this type of technology e.g. by use of remote inspection, rather than suggesting we choose an IT infrastructure that is more aligned with their inspection practices.
So, here’s to the 16th DIA EU EDM conference!