Home Forums General Discussion Forum creation and management of TMF on local/company’s drive Reply To: creation and management of TMF on local/company’s drive

#4015
Eldin Rammell
Participant

The MHRA have stated in their GCP Guide that this approach is unlikely to meet the applicable regulatory requirements. For example, no audit trails and limited security features. I’d advise reviewing carefully all requirements pertaining to the TMF and checking those against the functionality provided by network file storage.