WARDIAN
For Vault teams at Phase 3 and pre-commercial biotechs

Your Vault upgrades shouldn't wait for the next release.

Every upgrade your admins make can take 20 to 60 hours of work, and Veeva ships three releases a year on top. Ask Wardian for the upgrade in plain words, or let it watch the releases. It drafts the configuration package and the validation documents each one needs, sized to its risk. Your team reviews and approves in your own system.

Send us one upgrade Book a 15-minute demo

Describe one upgrade from your backlog. Get the drafts back within [3 business days]. No call attached.

Priya · QA Document Control
Can we add a second QA approval to the SOP workflow? Should be quick.
You ask Wardian
Add a second QA approval to the SOP lifecycle before Effective, with its own signature meaning.
Drafts ready for your review
Configuration PackageDRAFT
Change Control RecordDRAFT
Test Protocol (PQ)DRAFT

Sized to the risk. A new field would get far less.

You know how to build it. You're the one who has to say "next release."

A new field might need a line in the change log. A workflow upgrade needs a risk assessment, test scripts and a QA review: 20 to 60 hours, depending on the complexity. So upgrades wait for the next release, and the fix is late nights, early mornings or another consultant.

Business admin
Priya · QA Document Control
Can we add a second QA approval to the SOP workflow? Should be quick.
It’s never quick.
System admin
Sam · Vault System Admin
The change is configured in the sandbox. Ready for validation whenever you are.
Now someone writes the test scripts.
System admin
IT Director
The Veeva release lands next month. Can the three upgrades go in with it?
Then the late nights start.
Business admin
Jordan · New document owner
How do I get my SOP to Effective? It’s been sitting In Approval for a week.
You’ve answered this before. You’ll answer it again.

You know this system better than anyone. You should be spending your week improving it, not writing about it.

What it costs

The paperwork behind an upgrade takes weeks. Wardian drafts it in about 10 minutes.

Simple upgrade · today
1–2 weeks
about 20 hours writing the change control, risk assessment, test scripts and the rest
With Wardian
10 minutes
to draft the same paperwork, ready for your team's review.
Complex upgrade · today
Up to 8 weeks
about 60 hours writing the change control, risk assessment, test scripts and the rest
With Wardian
10 minutes
to draft the same paperwork, ready for your team's review.
Your year
Upgrades a year
Mostly
Today
80 hrs
$14.4K a year
With Wardian
40 min
of drafting, about 10 minutes an upgrade
Back each year
79 hrs
$14.2K

In the first month, one team saved 40+ hours of test script writing across eTMF and Quality Vault, and moved its upgrade timeline up by 6 weeks.

Estimates from our work with Vault teams: a simple upgrade takes about 20 hours of work over 1–2 weeks, a complex one about 60 hours over up to 8 weeks. Drafting takes about 10 minutes per upgrade in Wardian; in a real product run on demo data, a full test protocol took 4 min 40 sec. Both sides leave out testing and approval, which your team does either way, and the time your team spends reviewing the drafts. Cost uses $180 an hour, within the $160–200 consultant rates we hear. Veeva's own three releases a year are not counted.

How it works

Watch, Classify, Document. You decide.

  1. 01

    Map your system

    We model your Vaults and build a feature risk map. Your QA unit approves it in your own quality system. One team was live in under two weeks.

  2. 02New · Ask Wardian

    Ask, or let Wardian watch

    Ask for a change in plain words, or let Wardian watch every Veeva release. Each change is classified against your risk map, so the drafts match the risk.

  3. 03

    You decide

    You review and import. Your team approves in your own document management system.

Priya · QA Document Control
Can we add a second QA approval to the SOP workflow?
Watch 2:08
The upgrade · Ask Wardian

A package to import, and a guide to follow

Configuration Package · Change Guide

Sam · Vault System Admin
The change is configured in the sandbox. Ready for validation.
Watch 2:30
Validation · real product run

The documents the change needs, in your templates

Change Control · Risk Assessment · Validation Plan · Test Protocol · Traceability Matrix · Config Spec Review · Summary Report

Jordan · New document owner
How do I get my SOP to Effective?
Watch 1:09
The people around it · Ask Wardian

Answers for the questions that keep coming back

Training Deck · Report How-To

Videos use a fictional company and demo or synthetic data.

Try it on your own work · no call attached

Send us one upgrade you're sitting on. Get the drafts back in [3 business days].

Pick an upgrade from your backlog, the kind that's waiting for the next release, and describe it in plain words. Ryan reads every one. You get back what that upgrade needs, ready to review and to show whoever signs off.

What comes back, sized to the upgrade
  • Configuration package and change guide
  • Impact classification with its reasoning and citations
  • The validation drafts it needs: change control, risk assessment, test protocol

See a sample for a second QA approval (demo data) →

Leave out anything confidential; a plain description is enough. Drafts are graded against a reference risk map until your QA unit approves your own.

We've spent a decade on the other side of release week.

Wardian was built by Ryan Hoffman after ten years implementing validated GxP systems alongside the admins who run them. The build is usually the quick part. Wardian does the drafting around it.

RH
Ryan Hoffman
Founder & CEO
40+ hrs
of test script writing saved in one team's first month, across eTMF and Quality Vault
6 wks
sooner on that team's upgrade timeline
Indirect-impact validated
Rationale and evidence ready for your supplier qualification

Your team stays in control

  • Graded against your map. Every change is graded against the risk map your QA unit approved.
  • Approved in your system. Reviews, approvals and electronic signatures happen in your own document management system.
  • You deploy. Wardian reads and never writes. You review and import every configuration package.
  • No training on your data. Wardian does not train, fine-tune or otherwise adjust model weights using customer data.

Read more in the Trust Center →

For whoever signs off

Need a yes from IT or Quality? Send them this.

A one-page brief for your IT Director or Head of Quality: the cost estimate, how approvals stay in your system, the validation position and the proof points.

Questions

See all questions →

What happens to the upgrade I send you?

We use it only to draft your documents and send them back. Leave out anything confidential; a plain description of the upgrade is enough.

How did you get the cost figures?

From our work with Vault teams. A simple admin upgrade takes about 20 hours over 1–2 weeks, a complex one about 60 hours over up to 8 weeks. Wardian drafts the paperwork in about 10 minutes per upgrade; your team still reviews, tests and approves. Cost uses a rate within the $160–200 an hour consultant rates we hear. The estimate covers your upgrades only. Veeva’s three general releases a year add more; USDM estimates 40–120 hours of validation effort per Vault for each one.

Does Wardian change our Vault?

Wardian reads and never writes. It drafts the configuration package, and you review it and import it into Vault.

Who makes the GxP decisions?

Your team does. Every output Wardian produces is a draft until a qualified person approves it, and that person’s approval is the GxP record. This is enforced by system design, not by policy.

Is Wardian validated?

Wardian is validated as an indirect-impact system. It supports your GxP processes while your GxP records and decisions stay in your systems, and that is what sets the classification. We take your supplier qualification through the classification rationale and the evidence behind it.

Get your upgrades out of the backlog.

Start every upgrade from drafts sized to its risk, so it can move as soon as your team has reviewed it, without the late nights.

Send us one upgrade Book a 15-minute demo