Stage-Gate Reviews

The VP of Manufacturing Excellence at a top-ten pharma company once told me: "We do not have a project delivery problem. We have a project governance problem. Projects sail through early gates because nobody wants to be the person who stops a $100M initiative. By the time we realize the business case has eroded, we have spent $60M."

ProBeya's Stage-Gate module exists to solve exactly this problem. It provides structured governance checkpoints with predecessor enforcement, required documentation, designated approvers, GxP compliance flags, and an auditable record of every gate decision. The system makes it procedurally difficult to advance a project that has not met its gate criteria, and it preserves the decision rationale for regulatory and financial audit purposes.

Stage-Gate for Pharma Capital Projects

In pharmaceutical manufacturing, stage-gate governance is not optional. Regulatory agencies expect that capital projects affecting GMP operations follow a structured decision process. The FDA's guidance on process validation, the EU's Annex 15 on qualification and validation, and ICH Q10 on pharmaceutical quality systems all assume some form of phased project governance.

A typical pharma capital gate sequence:

Gate	Name	Key Criteria	Pharma-Specific Deliverables
G0	Business Case Approval	Strategic alignment, preliminary ROI	Capacity demand model, regulatory impact assessment
G1	Concept Design Review	Technical feasibility, preliminary budget	Process flow diagrams, URS (User Requirement Specification)
G2	Detailed Design Approval	Firm budget, resource plan, schedule	P&IDs, equipment specifications, qualification strategy
G3	Ready for Execution	Contracts placed, team mobilized	FAT protocols, commissioning plan, validation master plan
G4	Ready for Qualification	Construction/installation complete	Installation Qualification (IQ) protocols, punchlist closure
G5	Handover to Operations	Qualification complete, regulatory filing ready	Operational Qualification (OQ)/Performance Qualification (PQ) reports, tech transfer dossier

ProBeya supports this entire sequence through reusable gate templates that can be applied to any organization.

How It Works

Gate Definitions

Gate definitions are organization-level entities with:

• Name and code (e.g., "G2 - Detailed Design Approval")
• Description and sort order (determines sequence)
• Required documents: list of document types that must be attached before the gate can pass
• Required approvers: list of roles or individuals whose sign-off is needed
• GxP required flag: marks gates where electronic signatures and GxP documentation standards apply
• Predecessor gate ID: enforces sequential ordering; cannot schedule a review until the predecessor gate has been passed
• Active flag: inactive gates are hidden from new scheduling

tip

Create one gate template per project type. A "Pharma Capital Project G0-G5" template covers facility builds and major equipment installations. A "Technology Transfer G0-G4" template covers product transfers with a different emphasis on regulatory dossier readiness. A "Digital Plant G0-G3" template covers MES and automation projects with lighter governance. Standardizing templates across the portfolio reduces governance overhead while maintaining rigor.

Predecessor Enforcement

Before scheduling a review, ProBeya validates:

1. Project ownership: the project belongs to the caller's organization
2. Gate existence: the gate exists in the organization's gate definitions
3. Predecessor completion: if the gate has a predecessor, that predecessor must have a review with outcome pass or conditional_pass for this project

This enforcement is non-negotiable. A project cannot jump from G1 to G3 without passing G2. In pharma, where "we skipped the design review and went straight to construction" is a compliance finding, this structural enforcement prevents governance shortcuts.

Review Outcomes

The submitReview procedure records the gate decision:

• Pass: Project meets all criteria and advances to the next phase
• Conditional Pass: Project advances with documented conditions that must be resolved before the next gate
• Fail: Project does not meet criteria and must remediate before rescheduling the review
• Deferred: Review postponed; project remains at the current gate
• Pending: Review scheduled but not yet conducted

Each review captures the actual date, reviewer identity, condition notes, general review notes, and supporting attachments.

Gate Checklist

The getGateChecklist procedure compares required documents against provided attachments:

• Lists each required document with a provided flag
• Lists each required approver with an approved flag
• Computes a completion percentage based on document coverage

This checklist powers the pre-gate readiness assessment. In a well-run PMO, the project manager reviews the checklist two weeks before the scheduled gate review, identifies gaps, and resolves them before the steering committee convenes.

tip

Review the gate checklist at least two weeks before the scheduled review. This surfaces missing documents early, preventing the all-too-common "gate review deferred because the project team was not ready" pattern that wastes steering committee time and delays portfolio decisions.

Gate Status Overview

The getGateStatus procedure returns a comprehensive view of all active gates for a project:

• Each gate paired with its review (if any)
• Status computed: not_scheduled, scheduled, or completed
• The current gate highlighted: the first gate that has not been passed

This powers the gate progress tracker in the project dashboard, giving every stakeholder instant visibility into where the project stands in its governance journey.

Decision Framework: Conditional Pass vs. Fail

One of the most consequential decisions in stage-gate governance is whether to conditionally pass or fail a project:

Situation	Recommended Outcome	Rationale
Minor documentation gaps, core deliverables met	Conditional pass	Allows work to continue; conditions tracked in action log
Budget overrun < 10%, corrective plan credible	Conditional pass	Re-baseline at next gate with updated EAC
Fundamental technical uncertainty unresolved	Fail	Spending more capital before resolving the core risk is value-destructive
Regulatory strategy not aligned with target market	Fail	Misaligned regulatory approach can invalidate months of engineering work
Resource plan shows critical skill gaps	Conditional pass	Condition: hiring plan approved before execution begins

tip

Use conditional pass strategically. It should not become the default outcome that lets every project through. Track conditional pass rates at the portfolio level. If more than 40% of gate reviews result in conditional passes, the criteria may need strengthening, or projects may need better pre-gate preparation.

Gate Templates

Templates store predefined gate sequences that can be applied to an organization:

• List templates: browse all available templates
• Get template: view a single template with full gate definitions
• Apply template: creates gate definitions from the template, automatically linking predecessors in sequence

When applying a template, each gate is created in order, and the predecessor of each gate is set to the previously created gate, maintaining the governance sequence. Templates are additive: applying a template does not remove existing gate definitions.

Gate Deletion Protection

Gates with existing reviews cannot be deleted. All reviews must be removed first. This prevents orphaned review records and maintains audit integrity, a critical requirement for GxP environments where gate review records may be subject to regulatory inspection.

Permissions

Action	Required Role
Create/edit gate definitions	PMO or Admin
Delete gate definitions	Admin only
Reorder gates	PMO or Admin
Schedule reviews	Project Manager, PMO, or Admin
Submit review outcome	Gate Reviewer, PMO, or Admin
View gate status	Any project member
Manage templates	PMO or Admin
Apply templates	PMO or Admin

waspada

Gate predecessor enforcement means you cannot schedule Gate 3 until Gate 2 is passed or conditionally passed. Plan review meetings in sequence and allow buffer time for rework if a gate receives a "fail" outcome. For pharma capital projects, a gate failure typically adds 4-8 weeks to the schedule for remediation and re-review.

Related Features

• Projects -- Gates govern project lifecycle progression from concept to closure
• Risks -- Risk register status is a standard gate review input at every gate
• Budgets & Costs -- Budget baselines are typically created at each major gate passage
• EVM -- CPI/SPI thresholds are common gate review criteria (e.g., CPI > 0.90 required for G3 pass)
• PPM Overview -- Module-level context for the full PPM capability map