Global PV SDEA/contracts database

Home › Forums › Pharmacovigilance Forum › Global PV SDEA/contracts database

Viewing 1 post (of 1 total)
  • Author
    Posts
  • June 21, 2021 at 4:25 pm #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

  • Author
    Posts
Viewing 1 post (of 1 total)
  • You must be logged in to reply to this topic.