Validate and Maintain

Environmental monitoring device validation: URS and IQ/OQ

Validating an environmental monitoring device means writing a URS for its intended use, assessing the risks, then running an IOQ. The IQ confirms it was installed as specified, and the OQ proves it performs, with tests such as Data Integrity Verification, Temperature Monitoring Accuracy Study and Humidity Monitoring Accuracy Study.

A data logger, sensor or monitoring system that records temperature, humidity or other conditions of equipment or rooms. ValDoc drafts the URS, risk assessment, IOQ and SOP from the intended use you state, runs the IOQ at the bench and keeps its maintenance on the same record. It does not draft the PQ, which depends on your process. You write that as your own Protocol.

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Thirty minutes. Bring one piece of equipment.

What the URS specifies

ValDoc's URS for an environmental monitoring device starts from 20 requirements in 6 groups. You choose which apply and set each value. A few from each group are below.

Operating parameters2

  • Parameters monitored
  • Logging interval range

Capacity & dimensions2

  • Channels supported
  • Internal memory capacity

Design & construction3

  • System type
  • Compatible probe types
  • Portability

Control & interface10

  • Communication type
  • Data logging
  • Data storage location
  • and 7 more

Alarms & monitoring2

  • Alarm capability
  • Alarm notification types

Utilities & installation1

  • Power type

What the IOQ tests

ValDoc's starting protocol has 18 test cases: 9 installation and 9 operational. A few from each phase are below, and your team reviews and edits every test before the protocol is approved.

Installation qualification9

  • Settings Verification
  • System Condition Check
  • System Information & Nameplate Verification
  • and 6 more

Operational qualification9

  • Data Integrity Verification
  • Temperature Monitoring Accuracy Study
  • Humidity Monitoring Accuracy Study
  • and 6 more

Regulations that can apply

ValDoc's library holds 10 regulations from US and EU sources that can apply to an environmental monitoring device URS, including 21 CFR Part 11, EudraLex Volume 4, Annex 11 and EudraLex Volume 4, Annex 15. Which of them apply depends on its intended use.

United States4

European Union6

Every regulation in ValDoc's library

Maintenance and calibration

Maintain proposes 1 plan for an environmental monitoring device, and you confirm each cadence against the manual and your SOP. Each unit gets its own schedule and history, on the same record as its qualification. Maintain also offers 4 plans any family can use, such as Electrical Safety Inspection.

  • Calibration

    Every 1 year

    EMD Temperature, Humidity, Differential Pressure, and CO2 Sensor Calibration

Other equipment

ValDoc can still support equipment that is not on this list. Adding the equipment families a lab needs is part of onboarding, so tell us what you run.

Every equipment family

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.