Home Forums Archiving Archiving eTMF with no in house eTMF solution Reply To: Archiving eTMF with no in house eTMF solution

Eldin Rammell

I am not going to say that any specific vendor is more capable or less capable than another BUT please proceed with caution. There are very specific regulatory requirements relating to archiving. Many of these were written in the age of paper archives but the exact same principles MUST be applied when using a digital archive. In the same way that you would conduct a formal, documented assessment of an offsite paper document storage vendor (and possibly an audit), you must do the same for any technology solution for long-term digital storage of TMF content. You need to have assurance that the organization that you have outsourced the GCP-regulated archiving activity to is able to meet all applicable regulatory requirements.

The GLP guide on archives is a very useful document, in addition to the two HSRAA guides that Russell referred to.