If you manage documents in a regulated industry, you probably need electronic signatures that actually hold up during audits. This guide is for admins, QA folks, and anyone who has to set up or maintain electronic signature approvals in Veeva Vault. I’ll walk you through what matters, what’s a waste of time, and how to avoid the mistakes I’ve seen teams make over and over.
What Are Electronic Signature Approvals (and Why Should You Care)?
If you’re here, you probably know the basics: electronic signatures let you replace “wet ink” signatures with digital ones, as long as you do it right. Veeva Vault is a content management platform (learn more here) used by life sciences, pharma, and other regulated industries. Regulators (think FDA, EMA) expect signatures to be secure, auditable, and traceable.
Do this wrong, and you’ll be patching problems right before an inspection. Do it right, and you’ll save hours of pain and paperwork.
Step 1: Understand Veeva’s Electronic Signature Model
Before you touch any configs, get clear on how Veeva handles signatures:
- Veeva eSignatures ≠ DocuSign: Veeva’s signatures are built into Vault, not a third-party tool like DocuSign.
- 21 CFR Part 11 Compliance: The signatures are designed to meet FDA requirements (audit trails, identity verification, etc).
- Who can sign? Only users with Vault accounts and the right permissions.
- What can you sign? Usually approval steps in workflows tied to documents, records, or tasks.
Pro Tip: Don’t assume “eSignature” means the same thing everywhere. Veeva’s are tightly tied to workflows and permissions.
Step 2: Check Your Vault Security and User Setup
You can’t bolt on e-signatures to bad user management. Before enabling anything, make sure:
- Every signer has their own Vault user account. Shared logins are a non-starter.
- User roles and permissions are clean. No “admin for everyone”—that’s an audit fail waiting to happen.
- Passwords and authentication meet your compliance needs. Veeva supports SSO and password policies, but you need to enforce them.
What to ignore: Don’t waste time on “delegation” or “proxy” settings unless your process specifically needs them (most don’t).
Step 3: Map Out Your Approval Workflows
Electronic signatures in Vault are tied to workflows. If you don’t have a clear process, you’ll end up reworking everything later.
- List your approval steps. Who needs to sign? In what order?
- Decide what triggers a signature. Is it document review? Change control? Training completion?
- Plan for exceptions. What if someone’s out of office? (Hint: avoid “reassign to anyone” unless you want chaos.)
Honest take: Most teams overcomplicate this. Start with the simplest workflow that works, then refine it.
Step 4: Configure Electronic Signature Settings in Vault
Now the actual setup. You’ll need Vault Admin access.
4.1. Enable Electronic Signatures
- Go to Admin > Configuration > Electronic Signature Settings.
- Turn on Electronic Signatures for your Vault.
- Set your Signature Meaning options (e.g., “Approve,” “Reject,” “Acknowledge”).
- Configure password prompt frequency (how often users must re-enter credentials for signatures). Regulators expect this—don’t set it to “never.”
4.2. Set Up Signature Reasons and Meanings
- Go to Admin > Business Admin > Signature Reasons.
- Add reasons that match your process—these show up in signature dialogs.
- Don’t add 20 “meanings” because you might need them. Start with 2–3, expand if you must.
4.3. Attach Signatures to Workflow Steps
- Edit your workflow (e.g., “Document Approval”).
- For each step that needs a signature:
- Enable Require Electronic Signature.
- Set the Signature Meaning.
- Choose if comments are required.
- Save and activate your workflow.
Watch out: If you change a workflow mid-process, you can break in-flight approvals. Test changes in a sandbox first.
Step 5: Test the Signature Process End-to-End
Before you roll out to real users, do a dry run:
- Create a dummy document.
- Kick off your workflow.
- Walk through each approval step as a test user.
- Check that:
- The signature prompt appears at the right steps.
- Users have to re-authenticate (enter password/SSO).
- Audit trails record the signature event (who, when, why).
- The document status updates as expected.
Pro Tip: Download the audit trail and screenshot the signature dialogs. You’ll need this for your SOPs and future audits.
Step 6: Train Your Users (But Keep It Simple)
Most signature failures are user errors—people skipping steps, not knowing where to click, forgetting passwords.
- Write a one-page quick start guide with screenshots. Skip the 50-page manual.
- Do a short (15–30 min) live demo or screen recording.
- Remind users: never share passwords, and always complete the signature dialog fully.
What doesn’t work: Overloading users with theory about “electronic signature law.” Focus on what they need to do in Vault.
Step 7: Monitor and Maintain
Once you’re live, keep an eye on things:
- Run periodic audits: Pull audit logs monthly/quarterly. Look for skipped or failed signatures.
- Review user access regularly: Remove users who leave or change roles.
- Update workflows as needed: Only tweak if your process changes, not because someone “prefers a different button.”
Honest take: Most issues come from “set and forget” mentality. Check your setup at least twice a year.
Pitfalls and Gotchas (Learn from Others’ Pain)
- “Test” users signing approvals: This will get flagged in audits. Always use real, unique user accounts.
- Changing signature meaning midstream: Can cause confusion and audit gaps. Decide your meanings up front.
- Unclear signature reasons: Users just pick the first thing in the list. Keep your options short and clear.
- Relying on email notifications: Vault’s email alerts are basic. People miss them. Use dashboards/reports for oversight.
What Not to Overthink
- You don’t need to “integrate” with third-party e-signature tools unless you have a business case. Vault’s built-in system is enough for most.
- Don’t obsess over customizing signature reasons for every department. Standardize where you can.
- Custom code or scripts are almost never needed for e-signatures in Vault. If someone’s selling you a fancy add-on, ask why.
Final Thoughts: Keep It Simple and Audit-Ready
Electronic signatures in Veeva Vault aren’t rocket science, but they do require a methodical setup and some discipline. Start simple, document your process, and test before rollout. Most importantly, don’t let the perfect be the enemy of the good—get the basics working, then iterate.
If you’re stuck, don’t be afraid to ask for help or check the Vault Community. And remember: the best system is the one your users actually use (and your auditors can easily understand).