Hi All,

I am aware of the general and specific regulatory requirements for storage of essential documents (TMF/eTMF), archiving and from our own MHRA inspections at Cardiff University, the need for a faxed SAE/AE to contain and maintain metadata related to when it was received. Basically, our fax machine faxes produce a required header that details date and time of when we received it.

I was wondering if there are any further regulatory requirements that faxes would be restricted to, as we are looking into having a fully electronic fax system, wherein a fax server receives faxes and converts them to PDF format and e-mails designated individuals responsible for actioning as necessary the SAE/AEs.

We are aware that such an update will require greater controls over the electronic records and archiving policies and procedures we adhere to, along with other key criteria like sustainability, reliability, security and so on, but it would be incredibly useful if we could have guidance on any other conditions we need to address with any proposed system, like the header prioduction and retention within archives.

Thanks for any/all help,

Justin Philliips
IT & Web Officer - South East Wales Trials Unit