GxP Copilot · Protocols → execution → report

The V-model, closed-loop, in one workspace.

Installation, Operational and Performance Qualification protocols draft from your intake, execute in a mobile-friendly cockpit, and roll up into a Validation Summary Report. Step verdicts, evidence and deviations flow into the record without hand-typing.

Quick chat on WhatsAppPart of GxP Copilot

Anchored to requirementsLinked as it is drafted

Human reviewBefore anything is approved

In short

GxP Copilot manages the qualification stages end to end: protocols drafted and approved before execution, stage order enforced, evidence and signatures captured during execution, and stage release gated on everything in that stage being complete. The stage set matches the asset — software, instrument or equipment — rather than one template applied to all three.

The problem

Stages that overlap and gates that do not hold

Under schedule pressure, OQ starts before IQ has been reported and PQ borrows OQ's scripts with different credentials. It saves a fortnight and creates a package where the stages do not demonstrate different things, which is visible to anyone who reads it properly.

The other recurring problem is PQ run in a development environment. It is convenient, it looks like testing, and it proves nothing about the system people will actually use.

How GxP Copilot handles it

Order enforced, not recommended

The stage sequence is enforced. Execution is refused until the validation plan, the requirements and the protocol for that stage are approved, and a stage cannot be released while anything in it is incomplete or failed.

That removes the compression that most often has to be redone. It is a constraint people occasionally resent in week three and are grateful for during an inspection.

In context

Where iq / oq / pq management 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.

Validation planReported inValidation summary report

User requirements (URS)verified byPerformance qualification (PQ)

Functional specification (FS)verified byOperational qualification (OQ)

Design specification (DS)verified byInstallation qualification (IQ)

Build and configure the system

Risk assessment at every stageTraceability matrix links each row

The V-model under GAMP 5: each specification on the left is verified by the qualification on the right, and the traceability matrix links every row. Risk assessment runs through all of it.

The right stages for the asset

Software follows the GAMP 5 IQ/OQ/PQ structure. Instruments follow USP <1058>, which means design qualification, installation and operational checks against calibrated references, and a performance stage only where the instrument's group calls for one — a Group B instrument is not given a PQ it does not need.

Equipment follows EU GMP Annex 15, including factory and site acceptance and the critical process parameters that belong in the challenge tests. A SaaS application may legitimately have no IQ at all, and the platform treats that as a determined scope rather than a missing stage.

Reports that close each stage

Each stage produces its own report, approved before the next begins, summarising what was tested, what deviated and how it was resolved. The qualification or validation summary report then sits on top, and its release is gated on the whole picture rather than on the last stage alone.

Deliverables

What you get

Stage order enforced — no execution before plan, requirements and protocol are approved

Stage set determined by the asset: GAMP 5 for software, USP <1058> for instruments, Annex 15 for equipment

Stages that do not apply treated as determined scope, not as gaps

A signed report closing each stage before the next begins

Summary report release gated on the full project state

Summary

What IQ / OQ / PQ Management delivers

IQ / OQ / PQ Management 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.

IQ OQ PQinstallation qualificationoperational qualificationperformance qualification

IQ / OQ / PQ protocol packs
Mobile execution with evidence capture
Per-step verdicts and deviations attached
Auto-assembled summary report

FAQ

Common questions

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Can IQ, OQ and PQ be combined?

For low-risk systems a combined IQ/OQ is common and defensible when the validation plan records the rationale. Combining OQ and PQ is much harder to defend, because PQ has to demonstrate something OQ cannot: real users, representative data volumes and genuine processes in the production environment.

What if a stage does not apply to our asset?

It is recorded as a determined scope with its basis, not left as a gap. A USP <1058> Group B instrument may not require a performance qualification; a SaaS application may legitimately have no installation qualification. The platform distinguishes a stage that does not apply from a stage that was skipped.

Does the platform stop us running tests out of order?

Yes. Execution is refused until the plan, the requirements and that stage's protocol are approved, and a stage cannot be released while anything within it is incomplete or failed. Overlapping stages to recover schedule is the compression that most often has to be redone.

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