Veeva vault for EDMS and eTMF
Veeva Vault for EDMS and eTMF – managed by KLIFO
Managing critical documentation for Clinical Trial Supply and regulated activities is essential — but many biotech companies do not have the resources to run and maintain an in-house system.
KLIFO offers a managed Veeva Vault for EDMS and eTMF: secure, compliant, plug & play document management tailored for biotech, with no implementation project required.
KLIFO’s managed Veeva Vault solutions
You can choose our EDMS and eTMF as stand‑alone solutions, each tailored with its own configuration and pricing to match your specific needs. This means you only pay for what you require.
If you choose both, they work seamlessly together and give you the experience of a fully integrated platform without the complexity of managing two separate systems.
Both solutions are delivered in a fully GxP‑ and 21 CFR Part 11‑compliant environment with Read & Understand (R&U) tracking and rigorous access control.
Why biotech companies struggle with document management
Early-stage biotech companies often manage documentation informally—saving files on individual computers, shared drives or services like Dropbox.
This may work at first, but challenges mount quickly:
- Multiple versions of documents scattered across locations
- Unclear submission history: what was sent, when and where
- Risk of data loss or breaches, including ransomware attacks
These issues become acute when preparing for regulatory submissions (e.g. a Clinical Trial Supply Application) or investor due diligence—when complete, traceable and compliant documentation becomes mission-critical.
How KLIFO simplifies document management
At KLIFO, we don’t just provide a system — we offer a fully configured, maintained, compliant and secure environment, ready for immediate use, with minimal demand on your internal resources.
And we back this with expert guidance to help your team work effectively and confidently with your documentation.
Guidance through every phase
Document management is just one part of your clinical journey.
Explore how KLIFO connects EDMS and eTMF with every other phase of development
Example 1 – eTMF archive
A biotech company completes a clinical trial. Their CRO returns the eTMF on a USB stick—a non-compliant, insecure storage method.
KLIFO prepares a transfer plan, assigns a system administrator and an eTMF manager, and documents the entire migration process in accordance with KLIFOs Change Control procedure.
The eTMF is archived in our validated system for secure long-term retention, meeting all regulatory requirements.
Example 2 – Inadequate document overview before due diligence
A fast-growing biotech company realises it can no longer track document versions or locations when facing its first investor due diligence.
Within a week of signing with KLIFO, they gain immediate access to a compliant, secure EDMS tailored for biotech—no internal IT project required.
KLIFO also helps define best practices so their teams quickly regain control and confidence. Once the final documents are archived in the system, you can simply select those requested by the potential investor and share them in a secure, dedicated repository that functions as a Data Room.
Why choose KLIFO for managed EDMS and eTMF
KLIFO is not a traditional CRO. We combine senior insight with operational delivery.
When you work with KLIFO, you don’t just get immediate access to a secure, GxP-compliant Veeva Vault environment, you get:
- A setup specifically tailored to biotech needs and challenges
- Full system maintenance, user administration and ongoing support
- Best practice guidance from highly experienced experts
We help you bridge the gap between potential and approval — with secure, compliant document management designed to support regulatory requirements and investor due diligence from day one.
Ready to simplify your document management?
Contact us today to discuss how KLIFO’s managed Veeva Vault for EDMS and eTMF can help safeguard your documentation, protect your data integrity and allow you to focus on advancing your clinical programs.