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IQ, OQ and PQ for in-house equipment, traced end to end, in Matrix Validate

Qualify the lab and test equipment you build or configure in-house with the same traceability as your software: user requirements, design qualification and IQ, OQ and PQ protocols linked to the risks they address.

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Matrix Validate test execution dashboard on a laptop

The challenge

Qualification that depends on copy and paste

  • No vendor to delegate toFor equipment built or adapted in-house, there is no supplier IQ or OQ to lean on. Your team writes and runs every protocol.
  • Protocols copied from the last projectNew protocols start as a copy of an old one, carrying forward steps that no longer match the equipment.
  • Requalification after every changeMoving, repairing or reconfiguring a piece of equipment means working out which qualification steps to repeat.
  • Requirements lose their trailIt is hard to show which user requirement each PQ test proves once the documents have been through a few versions.
  • Evidence in too many placesPrintouts, photos and data files sit in folders, separate from the protocol they belong to.
  • Inspection questions on equipment historyAuditors ask for the full qualification history of a piece of equipment, and it has to be assembled by hand.

The solution

Qualification as connected data

Matrix Validate links each piece of equipment to its requirements, risks and protocols, so the qualification trail holds together through every change.

  • Equipment as itemsRecord each piece of equipment with its own ID, location, status and owner, and link it to everything that qualifies it.
  • URS and DQ linkedCapture user requirements and design qualification as items, and approve them before any testing starts.
  • IQ, OQ and PQ protocolsWrite protocols as test cases traced to the requirements they verify. Reuse proven steps across similar equipment.
  • Risk-based scopeUse the built-in risk assessment to decide what to test and how deeply, and trace every control to its test.
  • Change-driven requalificationWhen equipment or a requirement changes, linked protocols are flagged so you repeat only what is affected.
  • Signed qualification reportsGenerate qualification reports and trace matrices from live data and sign them with Part 11 compliant e-signatures.

Built for the equipment you qualify yourself

Matrix Validate is designed for in-house equipment, test rigs and lab instruments. Large commissioning and qualification programmes with paperless execution on the shop floor are not the current focus, so talk to us about fit first.

User requirements (URS)

Define what the equipment must do, with acceptance criteria, as individual items your team can review and approve.

Design qualification (DQ)

Show that the design or the selected equipment meets each user requirement before you build or buy.

Installation qualification (IQ)

Verify installation, utilities, components and documentation against the approved specification.

Operational qualification (OQ)

Test that the equipment operates as intended across its operating ranges, with results and evidence per step.

Performance qualification (PQ)

Prove the equipment performs consistently under real conditions, traced back to the user requirements.

Requalification

Rerun the affected protocols after a move, repair or change, and redline the documents to show what changed.

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FAQ

01What are IQ, OQ and PQ?

Installation qualification (IQ) checks that equipment is installed correctly. Operational qualification (OQ) checks that it works as intended across its operating ranges. Performance qualification (PQ) checks that it performs consistently in real use. Together with user requirements and design qualification (DQ), they form the qualification lifecycle described in EU GMP Annex 15.

02Does Matrix Validate support design qualification?

Yes. DQ is captured as its own set of items linked to the user requirements, so you can show that each requirement is addressed by the design before IQ starts.

03Can we qualify several similar instruments without rewriting protocols?

Yes. Copy a qualified project or reuse test cases across instruments, then adjust the items that differ, such as serial numbers or operating ranges.

04Does Matrix Validate cover process, cleaning or method validation?

Not today. Statistical process, cleaning and analytical method validation are outside the current product. Matrix Validate focuses on computer system validation and qualification of in-house equipment.

05How do we handle requalification after a change?

Update the equipment item or requirement that changed. Matrix Validate flags every linked protocol and test, so you can decide what to repeat and record the rationale.

06Where can I see the whole product?

Read the Matrix Validate overview or book a demo to see a qualification project for your own equipment.