04 June 2012
CSC: Too Late, He Cried: EVMPD Tools Now Need to Look to the Future - By Written by John Farrell, Principal Consultant, CSC Life Sciences
With just weeks to go before the EVMPD becomes mandatory, there is much talk about newly emerging software tools to support the XEVMPD messaging format.
The reality is any solution appearing now is too late. The point at which software tools to support the initial data take-on of the XEVMPD messaging would have really needed to be available to industry was early April. Realistically, most pharma companies require a minimum of three months to fully deploy and qualify a novel computer system. Somewhat unhelpfully, EMA were continuing to publish documents that altered the perceived requirements even after that date but "such is life".
In considering these new XML generation/upload and/or Gateway tools, many of which are designed to simply address the maintenance needs of the current XEVMPD requirements, it is questionable whether, on balance, it is good advice to industry to deploy such tools.
For small to medium pharma companies, which may have hundreds or even low thousands of XEVMPD records, the need for a specific software tool to address XEVMPD communications has always been questionable, especially once the initial bow wave of activity has been addressed, since the level of maintenance activity for these companies is likely to only be in the tens/low hundreds per annum.
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