Global PV SDEA/contracts database

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  • #42487
    orla.barron@teva.ie
    Participant

    Hi,

    We are assessing feasibility of options to move to a new system for SDEAs/other contracts (to act as a worldwide contracts repository). I would have 2 Q’s;

    – since we want that the system will have capability to produce validated report outputs (PSMF b1 + b2 Annex for example); should such a system be considered GxP applicable? i.e. subject to heavy computerised system validation

    – can anyone recommend a vendor(s)/software for such a system?

    Many thanks

    #42809

    Hi,

    Yes, it would be GxP applicable and needs to be validated.
    Not aware of any software but a database can be built on a SharePoint – which will just need to validated by your internal IT and will be cost effective.

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