20 March 2012

Pharma eReport Blog: Seven reasons to invest in an EVPRM system

Why should you invest in an EVPRM system if the EMA will be releasing a free one?   

Now that the race really is on to meet the July 2nd 2012 EVMPD compliance deadline, it’s a question that might occur to some Marketing Authorisation Holders as they start their vendor solution appraisals and selection process.  So, below is a brief response outlining why organisations need a vendor-supplied EVPRM system.  Here's seven reasons...
  1. The EMA system will not support your existing key business processes, such as efficient product life cycle management. The EMA system will not provide the capability to store past messages for you in a way that enables proper life cycle management and a robust audit trail.   A custom, professional-grade EVPRM system will offer a centralised database that efficiently tracks and logs all user activity, change tracking, and should also offer full harmonisation with your existing systems.  Additionally, with a custom system, the data can reside on your side and not with the EMA, allowing you to extract maximum value from your product information.
  1. The EMA tool will be a simple linear, web-form data entry tool – one allowing you to enter details for one MA at a time.   Our Centrality solution provides a choice of data entry options:
  • Simple fill-form: you can enter your Marketing Authorisation (MA) data sequentially, completing each section as needed. This solution follows the XML specification and documentation and is optimal for organisations submitting a small number of MAs (fewer than 10).
 
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