PLANNING
We build the foundation your cleanroom project depends on.
Most delays don’t start during construction—they start in planning. Vague scope, incomplete protocols, and unclear documentation force cleanroom project teams into rework, change orders, and compliance gaps that surface too late to fix without cost or delay.
Hygenix prevents those problems from taking root. We help teams establish structured, traceable foundations that align with GMP expectations, protect downstream execution, and accelerate readiness.
Where Planning Fails, Cleanroom Projects Drift
In regulated environments, missing or unclear planning creates risk at every level:
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URS was written too late to guide design or procurement
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SOPs drafted generically, with no alignment to facility workflows
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QMS assumptions that don’t translate to project documentation
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Commissioning plans disconnected from validation needs
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EH&S plans written for review—not execution
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RFPs that generate scope confusion instead of competitive clarity
Planning sets the trajectory. Done poorly, it guarantees cleanup. Done right, it saves months.
What We Deliver
Hygenix planning services connect your operational goals to the real-world requirements of a compliant cleanroom build. Our work helps you:
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Align project documents to cGMP, ICH Q9, and ISPE Baseline expectations
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Control scope drift through structured documentation
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Generate contractor-ready RFP and spec packages that reduce ambiguity
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Prepare your QA and operations teams with working SOP drafts
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Integrate QMS, commissioning, and risk plans into one cohesive project structure
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Make decisions early—before they become schedule threats later
You’ll get more than a planning binder. You’ll get a launch pad for controlled execution.
Our Planning Services
We tailor every engagement to your site’s risk level, modality, and regulatory profile. Planning deliverables include:
URS Development
Developed with operations, QA, and engineering to ensure traceability and compliance from design through turnover.
Site-Specific QMS
A documented QMS structure built for the project’s lifecycle—from doc control and deviations to handoff and audit trail.
SOP Development
We write SOPs that reflect how the facility will operate—early enough to guide training and handoff.
Commissioning Master Planning
A purpose-built CMP that defines testing scope, boundaries, responsibilities, and traceability to protocols.
Site-Specific Safety Plan
Project-specific EH&S protocols that support early mobilization, contractor safety alignment, and seamless integration into site programs.
