RECORDREFERENCE OUTLINE

Stage-Gate Quality Review Record

A gate-review record that fuses the project stage gate with the quality gate — capturing the quality acceptance criteria, evidence reviewed, open risks and actions, and the quality unit’s go / conditional-go / no-go decision at each phase boundary. Maps to ASTM E2500 and ICH Q9(R1).

REGULATIONS MAPPED

ASTM E2500ICH Q9(R1)

DOCUMENT TYPE

Record

LAST UPDATED

July 2026

PURPOSE

A gate-review record that fuses the project stage gate with the quality gate, so a project cannot pass a phase boundary while its quality acceptance criteria are unmet. It captures what was reviewed, what remains open, and the quality unit’s go / conditional-go / no-go decision — the audit-ready evidence of controlled progression.

What's Inside

✓Phase and gate identification with entry/exit criteria

✓Quality acceptance criteria for the gate and their status

✓Evidence and deliverables reviewed at the gate

✓Open risks, deviations, and actions with owners and due dates

✓The quality decision: go / conditional-go / no-go, with rationale

✓Signatures of the project and quality decision-makers

How to Use It

1Hold the gate review at each phase boundary defined in the Project Quality Plan

2Score each quality acceptance criterion against the evidence presented

3Record every open item as an action with an owner and a due date

4Record a conditional-go only with explicit, time-bound closure conditions

5Retain the signed record as inspection evidence of controlled progression

DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control

› Document Information› Approval Signatures› Revision History› Distribution List

1Gate Identification (Phase, Date, Attendees)

2Entry and Exit Criteria for the Gate

3Quality Acceptance Criteria and Status

4Evidence and Deliverables Reviewed

5Open Risks, Deviations, and Actions

6Quality Decision and Rationale

7Conditions and Closure Plan (If Conditional)

8Approvals and Signatures

REGULATORY CONTEXT

ASTM E2500 frames verification and acceptance against pre-defined criteria; ICH Q9(R1) requires risk-based decisions. This record makes the quality gate an explicit, signed decision point rather than an implicit assumption inside the project stage gate.

MAPPED STANDARDS

ASTM E2500ICH Q9(R1)

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