About PennVault

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About PennVault

     

 

SiteVault

        

 

eTMF: Electronic Trial Master File

 

About PennVault

PennVault document management applications are built on the Veeva Vault platform, a cloud-based, 21 CFR Part 11 compliant software package developed to help manage health authority-required records. Once access is granted, the applications are accessed using PennKey single sign-on login. PennVault provides a secure repository for documents, and enables document management for real-time inspection readiness.  PennVault enables for unique document identifications, version history, document search and retrieval, as well as paper certification. Users may collaborate on document creation and version management, and standardize document filing and classification. PennVault provides a secure electronic option outside of shared drives and paper binders.

SiteVault:

SiteVault is designed to manage the investigator site file or electronic regulatory binder. SiteVault allows for the centralized storage and use of documents such as protocols, informed consentsCVs, training certificates, and lab certifications. Paper certification and e-signature workflows are available in SiteVault.

eTMF 

Electronic Trial Master File (eTMF) is designed for the maintenance and storage of the essential documents for clinical trials as maintained by the sponsor. PennVault eTMF is designed to function for any type of trial, be it single site or multiple sites over multiple countries.  The eTMF organizational structure is based on the DIA TMF Reference Model. The eTMF may be used for the storage of documents as well as the author, review, transmission of documents for e-signature and approval.