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7 controlled decision gates1 contract-specific responsibility matrixGate-by-gate capital authorisation
CAPITAL PROJECTS, NOT EQUIPMENT ORDERS

The client owns a decision package at every phase.

No major capital commitment advances without defined inputs, responsibilities, acceptance criteria and a recorded investor decision.

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Healthcare project engineers coordinating cleanroom manufacturing infrastructure through a BIM delivery model
Coordinated delivery environmentEngineering · Integration · Qualification · Handover
01Investment Definition & Feasibility
02Clinical, Process & Concept Design
03Detailed Engineering & Infrastructure
04Procurement & Technology Integration
05Quality & Regulatory Readiness
06Installation, Commissioning & Qualification
07Training, Pilot Operation & Handover
WHY THE FRAMEWORK EXISTS

Healthcare projects fail at the interfaces.

An equipment line can arrive before power, HVAC or access is ready. A clinically correct layout can fail because the local licensing route was not assigned. A qualified system can remain idle because the future operator was recruited too late.

The 7-Gate Framework makes these dependencies visible before they become rework, delay or uncontrolled capital exposure.

01 / 07
CONTROLLED CAPITAL GATE

Investment Definition & Feasibility

Input
Investment objective, destination market, demand evidence, site information and funding assumptions.
Infinity IVD activity
Demand, capacity, site, preliminary CAPEX/OPEX, regulatory endpoint and risk are tested as one investment case.
Investor decision
Proceed, redefine or stop before design and equipment commitments begin.
DECISION PACKAGEFeasibility ReportCAPEX / OPEX BasisGo / No-Go Record

Investor risk reduced: The investor receives an evidence-based answer to whether the project is commercially and technically defensible.

Typical risks and control method +

Typical interface risks

  • Demand or capacity assumptions cannot support the business case.
  • The selected site cannot provide the required utilities, logistics or expansion.
  • The target regulatory endpoint is incompatible with the proposed scope.

How control is maintained

Infinity IVD records every assumption, source, exclusion and sensitivity. Missing evidence is marked as an open decision, not silently converted into a design input.

02 / 07
CONTROLLED CAPITAL GATE

Clinical, Process & Concept Design

Input
Approved feasibility basis, capacity tier, service or product scope and operator requirements.
Infinity IVD activity
Clinical programme, process flow, adjacency, zoning, concept layout, design basis and user requirements are coordinated.
Investor decision
Approve the design basis before detailed engineering changes become expensive.
DECISION PACKAGEDesign BasisConcept LayoutURS Framework

Investor risk reduced: The investor knows what the facility must do, how people and materials move, and which performance requirements govern procurement.

Typical risks and control method +

Typical interface risks

  • A building plan is developed without matching the clinical or manufacturing workflow.
  • Clean, public, staff, material and waste routes conflict.
  • Equipment is specified before throughput and interfaces are fixed.

How control is maintained

Process owners, operator representatives and engineers review the same controlled basis. Approval locks the functional intent while formal change control remains available.

03 / 07
CONTROLLED CAPITAL GATE

Detailed Engineering & Infrastructure

Input
Frozen concept, verified survey data, approved room programme and equipment utility requirements.
Infinity IVD activity
Architecture, MEP, HVAC, cleanrooms, medical gases, water, power, drainage, ICT, fire and waste interfaces are coordinated.
Investor decision
Release one coordinated design for construction and equipment integration.
DECISION PACKAGECoordinated DrawingsUtility ScheduleInterface Register

Investor risk reduced: The investor reduces rework caused by equipment, building and utilities being designed as separate projects.

Typical risks and control method +

Typical interface risks

  • Power, water, HVAC or medical gases are undersized.
  • Local design submissions diverge from the process basis.
  • Structural openings, access and maintenance clearances are discovered late.

How control is maintained

The interface register assigns every connection and design dependency to an owner. Reviews close clashes before procurement release or site installation.

04 / 07
CONTROLLED CAPITAL GATE

Procurement & Technology Integration

Input
Approved specifications, coordinated interfaces, commercial budget and delivery programme.
Infinity IVD activity
Vendor evaluation, equipment packages, lifecycle review, FAT, logistics, spares and installation responsibilities are controlled.
Investor decision
Authorise long-lead commitments only after technical and commercial alignment.
DECISION PACKAGEProcurement RegisterTechnical EvaluationFAT Record

Investor risk reduced: The investor knows what is being purchased, why it fits the process and where supply, installation and performance responsibility sits.

Typical risks and control method +

Typical interface risks

  • Nominal machine output is mistaken for validated facility capacity.
  • Interfaces, spares, training or service coverage are omitted from the order.
  • Long-lead equipment arrives before the site can receive or protect it.

How control is maintained

Packages are evaluated against the approved URS, total lifecycle, integration boundary and acceptance criteria - not catalogue description alone.

05 / 07
CONTROLLED CAPITAL GATE

Quality & Regulatory Readiness

Input
Intended market, legal operator, authorised service or product scope and selected technology.
Infinity IVD activity
QMS, validation master plan, licensing roadmap, document architecture and evidence gaps are assigned and scheduled.
Investor decision
Accept the readiness plan, evidence map and legal responsibility boundary.
DECISION PACKAGERegulatory RoadmapValidation Master PlanQMS Gap Register

Investor risk reduced: The investor sees which licences and evidence are required, who produces them and which authority decisions remain independent.

Typical risks and control method +

Typical interface risks

  • Licensing requirements are discovered after installation.
  • Supplier documents cannot support qualification or technical files.
  • The future operator is not ready to own sustained compliance.

How control is maintained

Applicable ISO, GMP, IVDR, ministry and local requirements are mapped to deliverables and owners. Certification or authorisation is never represented as guaranteed.

06 / 07
CONTROLLED CAPITAL GATE

Installation, Commissioning & Qualification

Input
Released site, approved equipment, installation drawings, protocols and calibrated test instruments.
Infinity IVD activity
Installation, SAT, calibration, commissioning, IQ/OQ where applicable and controlled punch-list closure are executed.
Investor decision
Grant provisional acceptance only when defined evidence and exceptions are visible.
DECISION PACKAGESAT CertificateIQ / OQ PackagePunch-List Record

Investor risk reduced: The investor avoids accepting an installed asset that has not demonstrated correct connection, operation and documented control.

Typical risks and control method +

Typical interface risks

  • Equipment is physically present but utilities or safety functions fail.
  • Open defects are hidden inside informal site correspondence.
  • Acceptance occurs without calibration, traceability or approved protocols.

How control is maintained

Acceptance status, exceptions, corrective actions and ownership are recorded. Open items remain visible until verified closure or formally accepted deviation.

07 / 07
CONTROLLED CAPITAL GATE

Training, Pilot Operation & Handover

Input
Qualified systems, recruited operator team, approved procedures and available pilot materials or patient-readiness plan.
Infinity IVD activity
Role training, simulation or pilot operation, performance review, maintenance planning and controlled handover are completed.
Investor decision
Approve operational handover, residual actions, warranty and lifecycle support plan.
DECISION PACKAGETraining MatrixPilot Operation ReportHandover Dossier

Investor risk reduced: The investor receives an operating capability with trained owners and records - not an equipment warehouse awaiting expertise.

Typical risks and control method +

Typical interface risks

  • The facility depends on external personnel after opening.
  • Procedures, spares and maintenance ownership are incomplete.
  • Pilot performance does not match the approved operating basis.

How control is maintained

Competence is verified by role. Handover records systems, documents, open actions, warranty, service, consumables and responsibility for sustained operation.

ILLUSTRATIVE RESPONSIBILITY MATRIX

One project. No invisible ownership gaps.

The final RACI is contract-specific. It records who is accountable, responsible, consulted and informed at every gate.

StakeholderG1G2G3G4G5G6G7
Investor / ClientAAAAAAA
Infinity IVDRRRRRRR
Local Architect / ContractorCCRCCRI
Equipment OEMICCRCRC
Technology OwnerCCCRRCR
Authority / Certification BodyCIIIACI
Future OperatorCCCCRCR
A AccountableR ResponsibleC ConsultedI Informed

The investor is never left uncertain about who owns the next action, evidence or decision.

Access sample framework & responsibility matrix ↗
AUTHORITY INDEPENDENCE

Infinity IVD delivers the contracted engineering, integration, quality and readiness work. Certification, licensing and market authorisation remain subject to competent-authority and conformity-assessment decisions.

FROM CAPITAL DECISION TO OPERATING CAPABILITY

Infinity IVD turns healthcare capital into functioning local capability.

Define the project now, or review the framework before opening a formal feasibility discussion.

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