Validate

Start with the manual. Finish with a signed IOQ.

Validate drafts your qualification documents from the equipment itself, puts review and signatures in one place, and runs the IOQ at the bench until it closes into one record.

46 hours today, 19 with ValDoc:

Hours of document work per new model

21 hours today, 11 with ValDoc:

Hours of execution and closeout per unit

Thirty minutes. Bring one piece of equipment.

NB-0002-URS

User Requirements Specification

High-speed refrigerated centrifuge

Revision 1

4. Performance requirements

URS-4.1

The centrifuge shall reach 15,000 rpm within 60 s of start.

21 CFR 211.68(a)EU GMP Annex 15 §3.2

URS-4.2

Temperature control shall hold the set point to ±1 °C.

21 CFR 211.160(b)EU GMP Annex 15 §3.2

URS-4.3

An imbalance shall stop the rotor and raise an alarm within 3 s.

21 CFR 211.68(a)EU GMP Annex 15 §3.2

Approved by

Dana Okafor

Quality approval, 12AUG2026 11:40:55 UTC

SHA-256 9f3c 7a21 … e41c

Start before the equipment arrives.

Write and approve the URS from the equipment family before you buy. When the equipment arrives, ValDoc compares its specifications with each requirement, you settle anything it cannot, and the signed Procurement Assessment records what was compared and who decided.

Procurement Assessment

2 meet · 1 gap

  • URS-4.1

    Reaches 15,000 rpm within 60 s

    MeetsConfirmed

  • URS-4.2

    Holds the set point to ±1 °C

    MeetsConfirmed

  • URS-4.3

    Stops the rotor on imbalance within 3 s

    Does not meet

Try it: settle the one requirement the equipment does not meet.

Drafted from the manual, cited to the regulation.

ValDoc reads the manufacturer's manual into a specification table, each value with the page it came from, and a specialist accepts or dismisses every one. The URS, risk assessment, IOQ and SOP are then drafted from those specifications, and each URS requirement cites the US and EU provisions it traces to.

  • Family templates written by validation specialists
  • Citations to the US and EU regulations you work under
  • Every AI value waits for a person

Suggested by AI

Maximum speed: 15,000 rpm

3 of 24 reviewed

Try it: nothing enters the record until you accept it.

Review in the document, together.

A full document editor with tables, figures and formatting. Comment on any passage, see who else is reading, and resolve threads as you go. The revision timeline marks every change, and each review round opens on what changed since the last one.

The right person signs.

Quality, Validation and Facilities roles decide who may approve what. Nobody approves their own work, every record in review names a Quality owner, and that approval is the last one. When a control is greyed out, it says why.

NB-0002-URS

Revision 1

In review

Your Quality approval is outstanding.

Try it: approve this URS as its Quality owner.

Execute at the bench, unit by unit.

Run the approved IOQ against each unit: record the reading, mark it pass or fail, attach evidence and sign. A failed test raises an exceptional condition with its own review, correction and approval, and ValDoc suggests evidence from records it already holds.

Close into one signed record.

The final summary report records the qualification decision, and ValDoc compiles the executed IOQ with every signature, exceptional condition and attachment into one PDF. A finalized record is locked, and its content hash would show any change.

Next moduleMaintain: Keep every unit in spec and in service.See Maintain

See your own equipment in ValDoc.

Bring one piece of equipment and its manual, and we’ll walk it through ValDoc with you, from the manual to the signed record.

Thirty minutes. Bring one piece of equipment.