Valigent

For Quality leaders in FDA-regulated life sciences

Your AI validation engineer.

End-to-end AI software validation for FDA-regulated companies in pharma and biotech, medical devices and diagnostics, and CDMOs, CROs and contract labs.

Our AI validation engineer plans, tests and documents every validation. Our team onboards it to your procedures. You review and sign.

Book a demo See how it works
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You run Quality. | We run your validation.

For Quality leaders at small and mid-size FDA-regulated companies, with little or no validation team.

“We can’t justify hiring a validation engineer.”

You don’t need to. Ours is built in.

“Consultants take weeks on every system.”

We plan, test and document it for you, end to end.

“Every vendor update means validating again.”

We check each release and retest only what changed.

What we do differently.

How it’s done today

  • Hire a validation engineer, or pay a consultant per system.
  • Weeks of test scripts, clicking and screenshots.
  • Every vendor update starts the cycle again.
  • Your team reviews, chases and signs it all.

How we do it

  • Our AI writes the plan, requirements, risks and test scripts.
  • It runs every test and saves the evidence.
  • It checks each vendor update and retests only what changed.
  • No hire, no consultant. Our team onboards it.
  • You review one package and sign. The AI never signs.

The entire workflow.

First, we onboard it to your company.

In onboarding sessions we take in your scripts, procedures, the regulations you work under, your company standards and instructions. The AI drafts your profile from them, quoting the source of every value, and we work with your team until its output meets your standard.

Then it writes and runs the tests.

Your team approves the test scripts. The AI works through each step in your test environment and saves a screenshot as evidence. Failures are classified, logged as deviations and retested.

Your quality team reviews and signs.

Traceability, the summary report and the PDF package are written for you. The verdict is computed by code from the stored results. The AI never signs; a qualified person on your team does.

Company profile · Draft, version 1

System
Acme ERP, from Acme Software
GxP use
Inventory with lot numbers, work orders with bills of materials, purchasing and shipping
Signers
Dana Whitfield, QA · Marcus Lee, system owner

Source · Discovery call, Dana Whitfield, Director of QA

“We use it for inventory with lot numbers, work orders with bills of materials, purchasing and shipping. It needs validation because of the traceability records.”

Source · Same call

“All validation documents are signed electronically in MasterControl.”

TP-002 · Work order quantities Failed

Action

On the same work order, change the batch size from 250 to 400 kits and save it.

Expected

Required quantity: 400 for TEST-COMP-A, 800 for TEST-COMP-B.

Actual

TEST-COMP-A 399 · TEST-COMP-B 799

ComponentPer kitRequired
TEST-COMP-A1399
TEST-COMP-B2799

Logged as deviation DEV-001 · retest scheduled

Acme ERP · Full validation · PKG-001

Verdict, computed by code

Not fit for intended use

4 open deviations · 38 of 42 steps passed · 4 failed · 0 never ran

Decision
Approved with conditions
Approver
Dana Whitfield, Director of Quality Assurance
Signed on
2026-10-25
Package
PKG-001.pdf, 153 pages, with the sign-off page

Northwind Biologics is our demo company. These panels and quotes come from Valigent's demo run.

Today’s cost. Our results.

The industry today · published figures

$40K–$120K

to have a vendor validate one system, over 6 to 12 weeks.
Source: IntuitionLabs, CSV pricing guide

78%

of companies outsource some of their validation work.
Source: Kneat, State of Validation 2024

60%

of validation professionals work in teams of one to six people.
Source: Kneat, State of Validation 2024

Measured on our practice system · Acme ERP demo run

8

vendor release changes read and decided, each with a quoted, checked source.

42

test steps across 8 test scripts, run by our test robot in about 16 seconds.

153

pages in the validation package, ready for review and sign-off.

Acme ERP is our practice system, built like a real ERP with bugs planted for the AI to find. Numbers on customer systems will come from our first pilots.

Now watch it work.

Watch it test this page.

Real inputs and expected outputs, the way it tests your systems. Every test runs 100 times and has to give the same result every time.

TP-WEB-001 · Functional test of this page

Test environment: your browser

Waiting

  1. InputPress any “Book a demo” button

    ExpectedOur 30-minute call calendar opens

    Waiting

    Waiting

  2. InputScroll to the booking section

    ExpectedThe same calendar is there to pick a time

    Waiting

    Waiting

  3. InputPress “Try a release check”

    ExpectedA window opens with all 8 changes

    Waiting

    Waiting

  4. InputPick change CH-001

    ExpectedAffected, traced to URS-004 and URS-005

    Waiting

    Waiting

  5. InputFollow every link in the menu and footer

    ExpectedEach one lands on its section

    Waiting

    Waiting

5 tests, each run 100 times.

What it does on its own

Workers in a hematology lab. Footage: CDC.
An FDA microbiologist in a full protective suit testing samples inside a biosafety cabinet. Two technicians in clean suits working at instruments in a clean room. A microbiologist in a lab coat streaking a culture plate at a lab bench. An FDA inspector seated among his equipment, laid out in front of a car: a typewriter, sample cases, tools and paperwork.
An FDA microbiologist tests samples in a biosafety laboratory, 2009.

Validated once is not validated forever.

In a company regulated by the FDA, the ERP that sets a batch, the system that stores a lab result and the one that ships a lot all have to be validated. Then they have to be validated again, every time the vendor ships an update.

Most of that is still done by hand, screen by screen. We take the software part off your team's plate: our AI does the work end to end, and we stand behind it.

Common questions

  • A validation company. Our own AI validation engineer does your software validation end to end, and our team onboards it and stays on hand.

  • It gets the validation work done without hiring or a consultant. If you have a validation lead, they steer it and approve its scripts; your quality team still reviews and signs.

  • No software is FDA-approved for this. We write your validation records and support your Part 11 compliance. Your people approve them.

  • Never. A person on your team reviews every result, and the sign-off is recorded with their name, role, date and decision.

  • The workflow doesn't depend on the vendor. NetSuite is first. Today it runs end to end against Acme ERP, our practice system with planted bugs.

  • Join the onboarding sessions, approve the test scripts before they run, then review and sign the package. We handle the rest.

  • GAMP 5, second edition, and the FDA's Computer Software Assurance guidance: intended use, risk, assurance activities and the record.

  • In its own encrypted database, one per company. Your documents are never mixed with another customer's.

Book a 30-minute call.

Pick a time that works. You'll get a calendar invite with a Google Meet link.

Open the calendar →

In 30 minutes you'll see it

  1. Read a vendor's release notes and decide what each change affects
  2. Run the affected tests and catch a planted bug
  3. Write the package your quality team reviews and signs

Prefer email? shayaniqbal2008@gmail.com

Release check

Acme ERP 2026.2. Pick a change to see what our AI decided, and why.

Acme ERP is our practice system, built like a real ERP with bugs planted for the AI to find. Release 2026.2 · 8 changes · 3 affected · 5 not affected · 0 uncertain.