As a vendor developing systems for managing content, records and processes in a number of areas of the Life Science value chain we are particularly interested in the establishment of standards. We have participated in the eTMF Reference
model development and observed its development over the years that the group has been operating. Over this time the model has matured with experience being fed into it over time leading to improvements. It is imperative that any standards initiative builds
upon this experience. OASIS brings experience from the standards development world which can again lead to a refinement of the standard, so long as alignment is built into the process.
As we as vendors look to develop systems based around the standard in order that clients can implement quicker and less expensively there is only one thing worse than not having a Standard to work with and that is having more than one Standard
to choose from !
Over time it can only lead to fragmentation in the initial phase and then wasted effort across the industry until alignment or victory is achieved within the standards world. Let us learn from the past lessons of duplication of effort and
build in that alignment from the beginning. There is then a better chance of achieving a universal standard to move forward with. That way vendors of systems can avoid the dilemma of having to select the path to take and clients/implementers can be less concerned
about picking the “Betamax” equivalent and having to change later on.
Jonathan Burd
Solutions Director
Events:
http://www.gpcmevent.com
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