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Dear all,
I am writing to gain an insight into your perspective on the changes implicated in Q-Pulse moving over to being cloud-based software in their next version of this system, and the impact on your CTU.
There are a couple of major issues which we will be pushing back on with Ideagen, not just from our CTU, but from all Users within Cardiff University, these issues being:
1) The significant increase in costings associated with both the licensing of the and migration of our current system to the new version of Q-Pulse.
2) The fact that legacy data will not be transferred over, thus losing the audit trail for the majority of the documents within our current QMS. This not only affects our clinical trials from the perspective of a Regulatory Inspection, it also will affect some of our colleagues with their ISO certification and therefore poses a substantial issue.
I look forward to hearing your responses, as I imagine that this will also affect a number of CTUs in a similar vein.
Many thanks,
Liz Merrifield
QA Manager, Centre for Trials Research, Cardiff University
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