These quick reference summaries provide an overview of SiteVault’s most helpful features, highlighting each feature’s structure and benefits. They also offer answers to frequently asked questions around function and compliance.
| Feature | Description | Resource |
|---|---|---|
| Digital Delegation | The Digital Delegation feature enables users at your site to delegate, accept, and approve responsibilities directly in SiteVault, and SiteVault creates or updates the DoA log document for you. | Open |
| Document Version Stacking | If you need to update or replace a document that already exists in SiteVault, the best practice is to stack a new version of the document on top of the existing document (instead of creating a new document). | Open |
| Electronic Signature (eSignature) | eSignatures provide a way for users to complete approval tasks and electronically sign documents. The electronic signature in SiteVault is nonbiometric and requires the application of two distinct components (a user ID and password) and is compliant with the Food and Drug Administration's (FDA's) 21 CFR Part 11 section §11.200 requirement of electronic signatures that are not based upon biometrics. | Open |
| Monitoring with SiteVault | SiteVault is an environment with site-controlled access, offering greater transparency for documents that are ready and available for review through the use of monitoring workflows and dashboards. | Open |
| Read and Understand Review | SiteVault offers the capability to send documents for read and understand review to staff members. This review process includes an attestation that the document(s) was Read and Understood by the user(s) within SiteVault, to record evidence of self-training on documents or videos | Open |
| SiteVault Memo for Sponsors | This memo is intended for sites to provide to a sponsor in the event of an audit as a supplement to the SiteVault Technical & Operational Security Whitepaper. | Open |
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