Vault Foundations Hub

Most customers leave validation documents in ComplianceDocs. This can be referred to in your own documentation, but downloading and saving into a separate system introduces a lot of maintenance as releases occur and validation documentation is upversioned.

Our procedures are summarized in documentation available to customers in ComplianceDocs Vault. To review our procedures in more detail, customers can work with our Quality team to schedule and perform an audit.

Veeva performs DR testing on an annual basis and makes summaries of that testing available to customers in ComplianceDocs Vault.

https://www.veeva.com/services/support-and-community/docs-access-request/

Yes, we do recommend performing change control for each release. The level of formality and testing can vary depending upon each customer’s Computer Systems Validation procedure, but it’s important to be able to document assessment and acceptance of auto-on features at a minimum to be able to maintain a validated state.

Generally the response is summarized on the Health Authority Question record but the full response is correspondence that can be associated to that HAQ

Yes, it is generally the author’s responsibility to address annotations, either by editing the document or by responding to or resolving annotations. The annotations will be version-specific – so if you were to upversion a document that has annotations on it, the annotations will be on the prior version. There is the ability to Bring Forward Annotations to the current version, though this is user-driven and not automatic.

That is correct; Vault is an open API so can be integrated with other CTMS systems. We have supported this with different systems in the past.

This can vary by organization and the roles involved. A common scenario would be a PM/CTA responsible for managing Study-level Expected Documents, Country Leads managing Country-level Expected Documents, and IHCRAs/CRAs managing Site-level Expected Documents. Some customers may have this centralized with a TMF Lead role, though there would still need to be a mechanism for study team input.

Yes, this can be configured depending upon the requirements – Vault does have Milestone Autocompletion functionality

They do not – the documents counts for Expected Documents look at unique documents in the Library but not versions

It’s not required that this configuration be done by Veeva; customers often have their own system admins. It ultimately comes down to having the knowledge and training around configuration

I would encourage potentially discussing with your Managed Services Consultant or CSM. We generally will see country templates customized to account for these differences so that items aren’t needed to be manually added

If EDL Automation si configured, then Vault will create person-specific Expected Documents in this case.

Yes – just be aware that there would likely be some initial effort to “catch up” # Expected, but Vault will match any existing documents

Milestones and ED’s will be site-specific. If you are reporting on completeness across all levels, then yes, this would change the overall completeness. But if you are reporting on these by site, then it would not change any of the completeness for your other sites.

The post-approval QC workflow is now part of our standard configuration for new Vaults; however, depending upon when you went live, configuration may be needed to enable this functionality.

Both options will create a new minor version of the document but Create Draft will also reset the status of the document to In Progress. For Approved documents, Create Draft should always be used to ensure that a document is not in the Approved state with a minor version.

QC is intended to be used for documents that originated and were finalized outside of Vault. The Approval workflow is intended to be used in conjunction with Authoring and Review for managing documents that are being created, edited and finalized within Vault.