Inspection Readiness

Vault eTMF and Inspection Readiness

By Luna González

Multiple Choice

The Compliance BEN has training material for Vault eTMF

• True

• False

​The Compliance Sharepoint ​has a lot of material to get started in Veeva Vault !

Multiple Choice

Prior to uploading documents to Vault you should check that:

• All revisions/updates are completed

• Track changes are accepted and turned off as applicable

• Internal peer review is completed as appropriate

• Documents are in their native format

• All of the options are correct

Multiple Choice

If you inadvertently inactivated or deleted a document, what would you do?

• Cry

• Open a HD ticket under “Vault eTMF- Document Problems” requesting to have this VV# reverted to the previous status

Open Ended

When you are assigned to perform Inspection Readiness for a document, what do you check/review?

GDMS019-006: GDMS Archival of Essential Documents

Overview of eTMF

Best Practices for archival

Common errors

Workflows and step by step

Multiple Choice

Which document provides the guidelines to classify and name each file uploaded to Vault eTMF

• GDMS019-005

• GDMS019-006

• GDMS019-008

GDMS019-005: GDMS Essential Document List

Some text here about the topic of discussion

Multiple Select

Inspection Readiness review should be completed in an ongoing basis and must be completed no more than ____ days from the document approval date

• 14

• 45

• 90

• This process does not have a limit of days to be performed

​GDMS019-008: eTMF Inspection Readiness Guide

Beginning 05-Apr-2021, Inspection Readiness review should be completed on an ongoing basis and must be completed no more than​ 90 days from the document approval date if archived on Study or Country level, or 45 days for Site level

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During milestones ​FSR/FPE; DBL & Post DBL/Archival it should be completed within 14 days

1. ​Use the TMF Completeness Dashboards in Vault

​Inspection readiness review need to be performed by different person than the one archiving documents into Vault, however it’s not required by our processes

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2. To complete the IR section in Vault, click Edit and complete the data in the corresponding section

​Perform Inspection Readiness review

​Perform Inspection Readiness review

Compliance BEN​ tool: Inspection Readiness Checklist

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