GxP Copilot · Protocols shaped by real risk

IQ, OQ and PQ protocols that reflect the risk you actually took.

Installation, Operational and Performance Qualification protocols are drafted from your requirements and design, right-sized by the risk engine, and structured for straightforward execution. Effort follows risk — high risk is scripted with an independent witness, medium is scripted or hybrid, and low risk can be unscripted with supplier evidence.

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Anchored to requirementsLinked as it is drafted

Human reviewBefore anything is approved

In short

GxP Copilot drafts IQ, OQ and PQ test cases from your approved requirements, with each case anchored to the requirement it verifies and acceptance criteria stated before execution. For instruments and equipment the cases read as qualification tests — inspect, challenge limits with calibrated references, demonstrate consecutive runs — rather than as software test scripts.

The problem

Test cases that verify nothing in particular

Two failures recur. The first is the acceptance criterion written as 'system works as expected', which cannot fail and therefore proves nothing. The second is the test case that exists without a requirement behind it, which an auditor will ask about and nobody will be able to answer.

There is a third, specific to qualification work: software test scripts dressed up as equipment tests. An autoclave does not have user acceptance scenarios. An auditor who qualifies equipment for a living notices immediately.

How GxP Copilot handles it

Anchored to requirements by construction

Every generated case is tied to the requirement it verifies at the moment it is created, so orphan tests and uncovered requirements are visible in the traceability matrix rather than discovered later.

Acceptance criteria are stated in advance, in terms that can actually fail. A criterion that cannot produce a failure is not a criterion, and the platform treats requirements that cannot be tested as a drafting problem to raise rather than a protocol to execute.

In context

Where test case generation sits in the lifecycle

Test design is stage 3 of six. Select any stage to see what happens in it.

Drafted by GxP Copilot

Reviewed and signed by your team, with a full audit trail

Step 3 of 6: Test designWhat GxP Copilot produces

Test cases sized to risk: scripted with an independent witness for high risk, scripted or hybrid for medium, unscripted with supplier evidence for low.

What your team decides

The test owner reviews and approves before anything runs.

Requirements: A requirement register with an ID for every requirement. Your validation lead confirms the requirements and which ones are GxP-relevant.Risk assessment: The system category from explainable rules, and a risk rating for each requirement from severity and probability, adjusted for detectability. QA reviews and can change any rating; the reason is recorded.Test design: Test cases sized to risk: scripted with an independent witness for high risk, scripted or hybrid for medium, unscripted with supplier evidence for low. The test owner reviews and approves before anything runs.Traceability: A traceability matrix built from the records themselves, so coverage gaps and orphan tests show as soon as something changes. Anyone can check coverage at any time; no spreadsheet to keep up to date.Deviations and changes: Deviations raised from failed steps and change controls that show which documents a change affects. Owners assess impact and close each item with a recorded decision.Summary and release: The validation summary report, assembled from the signed deliverables and the test results. Approvers sign with Part 11 electronic signatures, re-authenticating at the moment of signing.

High riskFailure could affect patient safety or product quality

Scripted testingWritten steps, expected results, an independent reviewer

Step-by-step results, screenshots and signatures

Medium riskFailure is noticed and contained

Unscripted testingExploratory or ad-hoc testing against the intended use

A record of what was tested, by whom, and the result

Low riskStandard function, supplier-tested

Supplier evidenceThe vendor’s own testing, assessed and accepted

The assessment and the reason it is enough

Computer Software Assurance in one picture: test effort follows the risk of each requirement. Based on FDA’s Computer Software Assurance guidance.

Written for the right lifecycle

Software gets the IQ/OQ/PQ structure a GAMP 5 package expects. Instruments get design qualification, installation checks, operational challenges against calibrated references and performance runs appropriate to their USP <1058> group — a Group B instrument does not get a PQ it does not need.

Equipment gets the Annex 15 sequence including factory and site acceptance, with critical process parameters carried through into the challenge tests. Where an instrument has a control system, the software component is covered under GAMP 5 in the same project.

Supplier tests used, not duplicated

Where a supplier has executed and documented testing you have assessed — a vendor's own operational qualification, a factory acceptance record — those results can be brought in, reviewed and accepted rather than repeated. Re-running what a reputable supplier already did and documented is duplication, not rigour.

Deliverables

What you get

Test cases drafted from approved requirements, each anchored to what it verifies

Acceptance criteria stated before execution, in terms that can actually fail

Qualification tests written as qualification tests, not as software scripts

Stage set matched to the asset — no PQ invented for an instrument that does not need one

Assessed supplier test evidence reviewed and accepted rather than duplicated

Summary

What AI Test Case Generation delivers

AI Test Case Generation is part of the GxP Copilot platform — an AI-native, CSA-first validation system built for regulated Life Sciences. See how it fits with AI Classification Engine, Risk-Based Validation Scoping, AI Risk Assessment.

AI test case generationOQ scripts AIPQ protocol AIGxP test authoring

IQ / OQ / PQ protocol drafting
Scripted, unscripted and vendor-evidence paths
Ready-to-execute structure
Editable end-to-end with full audit

FAQ

Common questions

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Are generated test cases usable as-is?

They are drafts for review. A validation lead reads them, adjusts the acceptance criteria where the generated version is not right for your process, and approves the protocol before any execution. The protocol must be approved before testing starts — the platform refuses execution otherwise.

How are instrument and equipment tests different from software tests?

They test different things. Instrument cases follow USP <1058> — installation checks, operational challenges against calibrated references, performance runs appropriate to the group. Equipment follows Annex 15 including factory and site acceptance with critical process parameters. Software follows the GAMP 5 IQ/OQ/PQ structure.

Can we use our supplier's executed tests?

Yes, where you have assessed the supplier. Their executed operational qualification or factory acceptance record can be brought in, reviewed and accepted against the relevant requirements instead of being repeated. The review and the acceptance decision are recorded as part of the package.

Related capabilities

All capabilities

AI Classification Engine

A guided intake — accelerated by AI, decided by your team — produces GxP impact, GAMP category and composite risk, along with the exact reasoning behind each result. Instead of week-long assessments, you get a classification you can defend to an inspector on the same day. The AI accelerates the input; the classification itself is transparent and controlled.

Learn more about AI Classification Engine Risk-Based Validation Scoping

The Strategy Engine picks the applicable deliverable set for each GAMP category and scales test rigor to per-requirement risk under CSA — choosing between scripted testing, unscripted verification, and leveraged supplier evidence. The output is a validation plan sized to reality, easy to defend, and quick to execute.

Learn more about Risk-Based Validation Scoping AI Risk Assessment

Every requirement is scored against an ICH Q9 lens for severity, probability and detectability. That score drives the test strategy, the traceability coverage and the inspection-readiness view — so risk stops being a compliance formality and starts sizing your actual work.

Learn more about AI Risk Assessment Document Control & Versioning

Every document version is fingerprinted and tagged with its provenance and any AI assistance used. Data-driven sections stay canonical across every deliverable — so what you sign is what you keep, and what you keep is what you show an auditor.

Learn more about Document Control & Versioning AI Validation Document Drafting

The Documentation Engine drafts your validation deliverables in the style of the templates your organisation already uses — with confidence checks, review gates, and a fully functional fallback when the AI is unavailable. Your team stays in control; the platform removes the drudge work.

Learn more about AI Validation Document Drafting Live Traceability Matrix

The Live RTM is always up to date — coverage gaps, orphan tests and inspection-readiness are computed on the fly from the links between requirements, design, tests and results. No more spreadsheet upkeep, no more RTM-freshness debates before an audit.

Learn more about Live Traceability Matrix