IQ OQ PQ protocol builder

How the calculation works

1. 01The structure follows the ordinary shape of a qualification protocol: purpose, scope, responsibilities, acceptance criteria, instrument calibration, the staged tests, deviation handling, report and references.
2. 02Installation Qualification covers identification, documentation, utilities, installation condition, components, instrument calibration status, software and safety features — the checks that establish what was actually installed.
3. 03Operational Qualification covers controls, setpoint, empty distribution and alarms, with door-opening and power-failure recovery added where the equipment type makes them meaningful.
4. 04Performance Qualification covers loaded distribution, routine operation over the study period, and the placement of permanent monitoring sensors justified from the distribution data.
5. 05Equipment-specific tests are added from the type you choose: vacuum leak rate and heat penetration for an autoclave, humidity distribution for a stability chamber, defrost effect for a cold room, seasonal extremes for a warehouse.

Limitations

• It does not write acceptance criteria and will not pretend to. They come from the product, the process and the quality system, and a generated limit would end up in a signed document being defended to an inspector.
• It makes nothing compliant. A protocol is compliant when your quality system says so after review; the frameworks named are the context you may be working to, not something this output satisfies.
• It does not know your equipment. The test list is ordinary practice for the type chosen — the real machine has features this cannot know about and may lack ones it assumes.
• The output is explicitly marked DRAFT — NOT FOR EXECUTION, and that marking is removed by a competent person after review and approval, not by this tool.
• It builds one document. The validation master plan that decides what gets qualified, on what risk basis and under what change control, sits above it.

Frequently asked questions

What is the difference between IQ, OQ and PQ?

Installation Qualification establishes that the equipment as delivered and installed matches what was specified — identification, utilities, documentation, components, and the calibration status of every instrument relied on. Operational Qualification establishes that it operates as intended across the range being qualified, normally empty: controls, setpoint, distribution, alarms, and recovery from disturbances like a door opening or a power failure. Performance Qualification establishes that it performs as required in routine use, loaded as it will actually be loaded. The sequence matters because each stage assumes the previous one passed — there is no point characterising an empty chamber whose control sensor has no calibration certificate.

Will this tool write my acceptance criteria?

No, deliberately. Acceptance criteria are the most important thing in a protocol and the one thing a generator must not invent, because they depend on the product, the process and the risk the quality system has accepted. If you leave the field blank the protocol prints an explicit marker where they belong rather than a default, so an unfinished protocol visibly looks unfinished. A plausible-looking generated limit is worse than a blank: a blank gets filled in, and a plausible number gets approved.

Can I use this protocol as it is?

No, and the document says so on its first page. It is a draft: the structure, a test list appropriate to the equipment type, record tables and approval blocks. A competent author then checks the tests against the equipment as it actually is, adds anything specific to the process, completes the criteria and the justifications, and takes it through your own review and approval. What it saves is the drafting, not the thinking.

How long should a qualification study run?

Long enough to cover the cycles the equipment actually goes through, which is the justification an assessor will ask for rather than a number from a template. For a cold room that usually means at least one full defrost cycle and a full day-night cycle; for a warehouse it means the seasonal condition you are claiming, or an argument for why the period you ran represents the worst case. The tool asks you for the duration and reminds you to justify it, rather than suggesting one.

Do I need all three stages every time?

Not always. A requalification after a change may only need the stages the change touched, and a piece of equipment moved but not modified may need IQ and a reduced OQ rather than the full sequence. The decision is a risk-based one belonging to your validation master plan. The builder lets you select any combination, including a single stage, and adjusts the document accordingly.

Which equipment types are supported?

Cold rooms, freezers, ultra-low freezers, pharmacy refrigerators, stability chambers, incubators, drying and depyrogenation ovens, autoclaves, freeze dryers, warehouses and transport containers. Each brings its own tests — an autoclave gets vacuum leak rate, air removal, heat penetration and a biological indicator challenge; a stability chamber gets humidity distribution and recovery; a warehouse gets seasonal extremes and dock door effects.