Validate

Start with the intended use. Finish with a signed IOQ.

Validate drafts your qualification documents from the intended use and the specifications that apply, 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 close-out 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 211.68EU GMP Annex 15 §3.11(i)-(ii)

URS-4.2

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

21 CFR 211.68EU GMP Annex 15 §3.9(iv)EU GMP Annex 15 §3.11(i)-(ii)

URS-4.3

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

21 CFR 211.68EU GMP Annex 15 §3.11(i)

Approved by

Dana Okafor

Quality approval, 12AUG2026 11:40:55 UTC

SHA-256 9f3c 7a21 … e41c

Write the URS before you buy.

Write and approve the URS from what the equipment has to do. Your Regulatory profile's markets decide the jurisdictions, the equipment's intended use decides which of their regulations apply, and the URS records what applies, what doesn't and why. 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.

Once it arrives, the manual fills in the specifications.

When you have the equipment, 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 the URS requirements cite the clauses they trace to.

  • Family templates written by validation specialists
  • Citations to the regulations that apply to the intended use
  • 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 approval

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.

  • Built for tablets at the bench, iPad or Android
  • Made for patchy site Wi-Fi: a failed save keeps your entries, and uploads resume
  • Controls sized for a finger and kept clear of the keyboard

Close into one signed record.

The summary report records the disposition, 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, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.

Thirty minutes. Bring one piece of equipment.