Project Delivery Readiness

Rate a regulated capital or system project across eight quality gates — from regulatory strategy and URS through C&Q, PPQ, change control, and inspection readiness. Returns a readiness score, a go/no-go band, and the priority gaps to close before go-live. The depth companion to the Regulated Project Delivery lifecycle.

WHAT THIS CALCULATES

Whether a regulated project is ready to pass its next gate, scored across the eight quality gates that run from concept to commercial release — and which gates are still open. A single open gate can stop a go-live regardless of how good the average looks.

THE METHOD

gateScore

0 not started · 1 partial · 2 complete · 3 complete and verified

gates

the eight quality gates across the regulated delivery lifecycle

readiness%

whole-number percentage of the maximum score

The conjunction is the model. A project can average well and still be blocked, because one unaddressed quality gate stops a regulated go-live on its own — so ≥85% with any gate at 0–1 is reported as conditional, not ready. Below 70% it is not ready. The gates are a SPEQ synthesis of what must be satisfied across the lifecycle, not any single body’s checklist.

THE INPUTS, AND WHAT THEY MEAN

The eight gates

Score the evidence, not the plan. Complete (2) means the deliverable exists and is approved; verified (3) means someone independent has confirmed it does what it claims. "In progress" is a 1 however far along it is.

Quality-owned gates

Several gates — the ICH Q9 risk assessment, change control on the asset, ALCOA+ documentation — are owned by quality rather than the project. They are the ones most often assumed complete by a project manager and scored lower by QA.

HOW TO READ THE OUTPUT

• ›Ready means ≥85% with no gate below 2. Conditional means the average is there but at least one gate is not, and that gate is the entire message.
• ›Gate scores diverge by role, and that divergence is useful. If the project manager and the quality lead score the same gate differently, the gap between them is the real finding.
• ›Change control being live on the asset is the gate most often deferred and most often regretted. Once the asset is in use without change control, every subsequent modification needs retrospective justification.
• ›This scores the gates, not the schedule. A project can be on time and not ready, and the point of a gate model is to make that visible before go-live rather than after.

WORKED EXAMPLE

A project nearing handover has six gates complete and verified, but ALCOA+ documentation assurance and the inspection-readiness handover plan are both only partially done.

Six gates

3 — complete and verified

Documentation & data integrity (ALCOA+)

1 — partial

Inspection readiness & handover plan

1 — partial

Eighty-three percent with six gates fully verified reads like a project about to land, and it is not — it misses the 85% bar and, more importantly, has two open gates. Both are the ones that matter at handover: without ALCOA+ assurance the records supporting all six completed gates are in question, and without a handover plan the receiving organisation inherits an asset it cannot yet operate compliantly. These are the gates that get deferred because they feel administrative, and they are the ones that stop a go-live.

REGULATORY BASIS

ASTM E2500-20

Risk- and science-based verification across the project lifecycle, including the specification and design gates.

ICH Q9(R1)

Quality risk management as the basis for the risk assessment gate and for scaling effort across the project.

ISPE Good Practice Guide: Project Management in the Pharmaceutical Industry

The regulated-project delivery framing the gate structure draws on.

EU GMP Annex 15

The qualification and validation lifecycle the delivery gates are built to satisfy.

LIMITATIONS — READ BEFORE YOU RELY ON THIS

• ›This is an analytical aid, not a validated system, and a self-assessment. Reproduce the judgement with quality and the receiving organisation scoring independently — the divergence between them is usually more informative than the number.
• ›The eight gates are a SPEQ synthesis, labelled as such. They are not a checklist any regulator or body publishes, and your own stage-gate procedure governs.
• ›It scores gate completion, not technical adequacy. A verified gate can rest on a poor risk assessment, and nothing here would show it.
• ›It has no view of schedule, cost or resourcing, and no view of dependencies between gates — a project can be gate-ready and still undeliverable.

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