# Which eTMF software centralises trial documentation and tracks approvals while maintaining a complete audit trail for regulatory readiness?

<p class="elv-tracking-normal elv-text-default elv-font-figtree elv-text-base elv-leading-base elv-font-normal" elv="true">Looking for input on<a class="a a--md" elv="true" href="https://www.g2.com/categories/electronic-trial-master-file-etmf"> Electronic Trial Master File (eTMF) software</a> for centralisation, approval tracking, and audit trail quality.</p><ol>
<li>
<a class="a a--md" elv="true" href="https://www.g2.com/products/mastercontrol-quality-management-system/reviews"><strong>MasterControl Quality Management System</strong></a>: Electronic approvals, audit trails, and tracking provide a clear record of every approval step with timestamps. </li>
<li>
<a class="a a--md" elv="true" href="https://www.g2.com/products/kivo/reviews"><strong>Kivo</strong></a>: Kivo's separate inspector access mode is specifically designed for regulatory inspections. Auditors receive a dedicated access level that allows them to navigate the TMF and document history without requiring full system credentials or a staff escort through the interface. </li>
<li>
<a class="a a--md" elv="true" href="https://www.g2.com/products/veeva-vault/reviews"><strong>Veeva Vault Platform</strong></a>: Provides a clear audit trail for end-to-end regulatory activities oversight and the ability to integrate with other cloud tools — the enterprise-scale audit centralisation that large pharmaceutical sponsors require. </li>
<li>
<a class="a a--md" elv="true" href="https://www.g2.com/products/viedoc/reviews"><strong>Viedoc</strong></a>: The audit trail and monitoring dashboard provide real-time visibility into study data and query status, enabling compliance monitoring throughout the study rather than only at closeout. Data exports are described as clean and immediately usable, reducing the manual audit preparation overhead. </li>
<li>
<a class="a a--md" elv="true" href="https://www.g2.com/products/egnyte/reviews"><strong>Egnyte</strong></a>: The version history and who-and-when activity logs are production-validated audit mechanisms. </li>
</ol><p class="elv-tracking-normal elv-text-default elv-font-figtree elv-text-base elv-leading-base elv-font-normal" elv="true">For clinical teams that have used an eTMF audit trail during an actual regulatory inspection, did the inspector navigate the trail independently, or did your team need to extract and present the evidence? </p>

##### Post Metadata
- Posted at: 9 days ago
- Author title: Marketing Executive
- Net upvotes: 1


## Comments
### Comment 1

The inspector question at the end is the sharpest part of this post, because inspections have shifted toward exactly that: inspectors asking for direct read-only access instead of requesting documents one by one. That flips what matters. Every platform here logs who did what and when. The differentiator is whether you can hand an inspector scoped access, this study only, no drafts, no unrelated programs, without a scramble. Kivo&#39;s inspector mode is the right idea and the right question to put to every other vendor. And there&#39;s a self-diagnostic hiding in it: if the thought of an inspector browsing unescorted makes your team nervous, the problem usually isn&#39;t the audit trail, it&#39;s that you don&#39;t know what the system would show. Better to find out before they do.

##### Comment Metadata
- Posted at: 8 days ago
- Author title: Tech Consultant





## Related discussions
- [How well does Trello scale into a larger team?](https://www.g2.com/discussions/1-how-well-does-trello-scale-into-a-larger-team)
  - Posted at: about 13 years ago
  - Comments: 6
- [Can we please add a new section](https://www.g2.com/discussions/2-can-we-please-add-a-new-section)
  - Posted at: about 13 years ago
  - Comments: 0
- [Quantifiable benefits from implementing your CRM](https://www.g2.com/discussions/quantifiable-benefits-from-implementing-your-crm)
  - Posted at: about 13 years ago
  - Comments: 4