IQ OQ PQ execution workspace: record results and deviations
Run a qualification, not just write it. Record each IQ, OQ and PQ test's result against your own acceptance criterion, raise and close deviations, see what stops a stage closing, and export a summary. Your work is kept in this browser.
Your qualification
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IQ · 8 tests
IQ-01Equipment identificationNot run
Record the manufacturer, model, serial number, asset identifier and physical location. Photograph the rating plate.
Record: Manufacturer, model, serial, asset ID, location, photograph reference
IQ-02Documentation receivedNot run
Verify that the manufacturer's manual, wiring or P&ID drawings, certificate of conformity and any supplier qualification documents have been received and filed.
Record: Document titles, revisions and file references
IQ-03Utilities and servicesNot run
Verify the supplies the equipment requires are present and within the manufacturer's stated requirements: electrical supply and protection, water, drainage, compressed air or gases as applicable.
Record: Each service, its measured or stated value, and the requirement it was checked against
IQ-04Installation conditionNot run
Verify the equipment is installed as specified: level, clearances, ventilation, securing, and that no transit damage is present.
Record: Observations against each installation requirement
IQ-05Component inventoryNot run
Record the critical components — controller, sensors, compressor or heater, fans, door seals — against the specification or purchase order.
Record: Component, specification, as-installed detail
IQ-06Instrument calibration statusNot run
Record every instrument that will be relied on, both the equipment's own control and monitoring instruments and the test instruments used for this qualification, with certificate number, calibration date and due date.
Record: Instrument, serial, certificate number, calibration date, due date, uncertainty
IQ-07Software and firmwareNot run
Where the equipment carries a controller with configurable software, record the version, the configuration or recipe loaded, and how it is protected from unauthorised change.
Record: Software name and version, configuration reference, access control arrangement
IQ-08Safety featuresNot run
Verify the safety devices present — over-temperature cut-out, pressure relief, interlocks, emergency stop — are installed and identified.
Record: Device, setting where readable, installed condition
OQ · 8 tests
OQ-01Controls and indicatorsNot run
Operate each control and verify the corresponding indication responds as the manual describes.
Record: Control, action, observed response
OQ-02Setpoint controlNot run
Set the equipment to the operating setpoint and allow it to stabilise. Record the controller indication and the independent reference measurement.
Record: Setpoint, controller reading, reference reading, time to stability
OQ-03Empty chamber temperature distributionNot run
With the equipment empty and stabilised at setpoint, record from distributed sensors over the study period to characterise the space itself.
Record: Sensor positions, full data set, minimum, maximum, mean and gradient per sensor
OQ-04Alarm functionNot run
Force or simulate an alarm condition at each configured alarm and verify it annunciates locally and, where applicable, remotely.
Record: Alarm, how it was induced, set point, observed annunciation, delay before annunciation
OQ-C1Defrost cycle effectNot run
Record through at least one complete defrost cycle and characterise the excursion it produces at each sensor position.
Record: Defrost start and duration, peak excursion per position, recovery time
OQ-C2Air distributionNot run
Observe or measure airflow from the evaporator across the room, and identify positions shielded from circulation.
Record: Observation method, airflow findings, positions identified as poorly served
OQ-D1Door opening and recoveryNot run
With the equipment stabilised, open the door for a defined period representing worst-case routine access, close it and record the excursion and the time taken to return within limits.
Record: Door-open duration, peak excursion at each sensor, recovery time
OQ-P1Power failure and recoveryNot run
With the equipment stabilised and loaded as agreed, interrupt the power supply for a defined period, restore it, and record both the excursion during the interruption and the behaviour on restoration.
Record: Interruption duration, temperature profile throughout, time to recover, controller state and any alarms on restoration
PQ · 3 tests
PQ-01Loaded temperature distributionNot run
Repeat the distribution study with the equipment loaded as it will be in routine use, including the maximum and minimum load conditions to be qualified.
Record: Load configuration, sensor positions, full data set, minimum, maximum, mean and gradient
PQ-02Routine operation over timeNot run
Operate the equipment under normal conditions for the qualification period, with normal access and normal loading, and record continuously.
Record: Full monitoring record for the period, with any interventions logged
PQ-03Monitoring sensor placement justificationNot run
Using the results of the distribution studies, identify the positions for permanent monitoring sensors and record the rationale.
Record: Chosen positions, the data supporting each, and the reasoning
Deviations
None. Raise one from a test, or here.
Names and the summary
prepared by
reviewed by
approved by
Typed names and dates only. They are not electronic signatures.
Not ready to put in front of approvers: IQ: not started. OQ: not started. PQ: not started. Nobody is named as having prepared the record.
Cold room: a walk-in cold room used for the storage of temperature-sensitive product
How the calculation works
- 01The tests come from the same lists the protocol builder uses for the equipment you choose, so what you execute matches what you drafted. Door-opening and power-failure tests can be switched off where they do not apply.
- 02A stage is called complete only when its record is complete and consistent: every test has a result, every pass that needs a criterion has one written down, every not-applicable has a reason, every failure has a deviation raised, and no deviation is still open.
- 03A failed test keeps its stage in a failed state until the repeat result is recorded, so a failure cannot be closed by closing its deviation alone. A stage closed after a deviation is shown as complete with deviations, never as simply complete.
- 04Missing evidence references, and missing names or dates for who ran a test, are shown as warnings. They do not block a stage, but they are what an auditor asks for first.
Limitations
- It never decides whether a result is acceptable and never supplies a criterion. A pass is whatever the person running the test says it is against the criterion they typed.
- It never says the equipment is qualified or validated. That is for your approvers to decide under your quality system, and the summary says so.
- Names and dates are typed text, not electronic signatures, and the workspace is not a validated system of record. Treat the export as a working copy that feeds your controlled document, not as the controlled document.
- Work is kept in this browser only. It survives a reload but not a different browser or a cleared cache, and there is no sharing between people, so export it to keep or hand over a copy.
Frequently asked questions
- What is the difference between IQ, OQ and PQ?
- Installation qualification shows the equipment was installed as specified. Operational qualification shows it operates as intended across its range, including alarms and recovery. Performance qualification shows it performs in real use, loaded and over time. They are usually done in that order, because a later stage assumes the earlier one holds.
- What should I do when a qualification test fails?
- Record the failure, raise a deviation, investigate the cause and its impact, and take corrective action. Then repeat the test and record the new result. This workspace keeps the stage open until the failure has been resolved and the deviation closed, so a failure cannot be quietly left behind.
- Can I run OQ before IQ is finished?
- You can record results in any order and the workspace will not stop you, but it flags it, because a later stage normally waits for the one before it. If you have a reason, say so in the observations.
- Does this replace my validation documents?
- No. It is a working record of execution. The controlled protocol and report live in your quality system, and the summary you export is an input to them.
- Who can see what I enter?
- Only you. Everything stays in your browser's local storage and is never sent to our servers. That also means it cannot be recovered if you clear your browser data, which is why there is an export button.
Need the reasoning, not just the number?
Ask ValiTrac AI and see the standards evidence and the engine calculation behind the answer.
Ask ValiTrac AIRead the theory
EU GMP Annex 15: the qualification stages explained
Annex 15 sets URS, DQ, FAT/SAT, IQ, OQ and PQ as a sequence that builds evidence a system is fit for its intended use, with requalification after changes.
How to structure a qualification protocol
A protocol says what will be tested, how, by whom, and what result counts as a pass — all approved before execution begins.
What a validation master plan should contain
The VMP is the site-level statement of validation policy, scope, responsibilities and schedule. It shows an inspector how you decide what to validate.
Qualifying a stability or climatic chamber
Chambers are qualified for temperature and humidity uniformity, stability and recovery — with acceptance criteria tied to the ICH conditions they will run.
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