Information Systems (IS)
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We are looking into implementing QPulse to manage better our documentation, SOPs, CAPA, Assets, Labs etc. However, we are now trying to find out the level of validation required for QPulse ( IQ, OQ, PQ scripts).
Manufacturer – Ideagen does not provide Validation Documentation with the installation package, but they would sell separately this service/ validation scripts at very high prices, depending on the level of Validation chosen.
If any of the Trials Units are using QPulse, could you share your experience with QPulse and if you validated this software in-house or chose to pay manufacturer for Validation scripts?
We may or may not add Study Participant information (Lab Results) in QPulse and given this purpose for QPulse may require that we validate QPulse to a MHRA compliant level.
King Regards and Many Thanks
Mihaela Barbu
Swansea Trials Unit IT Manager
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