Global PV SDEA/contracts database

[orla.barron@teva.ie]

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

[darpana_n@hotmail.co.uk]

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.

• This reply was modified 1 year, 5 months ago by darpana_n@hotmail.co.uk.

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