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Commissioning, Qualification & Validation

We are the industry leader in CQV, well versed in every phase from validation master planning, to CQV execution, to ongoing maintenance.

With extensive experience across all therapeutic modalities and equipment, we can drive CQV through your entire asset lifecycle—effectively, safely, and efficiently preparing you to achieve compliant manufacturing capacity.

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    Validation Program Development

    • Policies and standard operating procedures
    • In-class room training
    • Qualification and certification
    • Life-cycle validation
    • Methodologies
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    Process Validation

    • Master batch records process
    • Performance qualification
    • Process performance
    • Qualification summary reports
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    Validation Maintenance

    • Periodic review and validation maintenance plan
    • Re-qualification protocols
    • Validation maintenance summary reports
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    Laboratory Validation

    • Part-11 Compliance Assessments & Testing
    • Commercial Off-The-Shelf (COTS) Qualification
    • Method Validation
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    Commissioning & Qualification Lead

    • Validation Master Plan 
      C&Q Plan
    • Risk Assessments & Leveraged commissioning (e.g. ASTM E2500)
    • Vendor Audits Engineering & Validation Document Approval
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    Steaming Validation

    • Steaming Validation Strategy & Master Plan Cycle Development
    • IOQs, PQs, PQSRs
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    Cleaning Validation

    • Cleaning Validation Strategy & Master Plan
    • Cycle Development DHT & CHT
    • IOQs, PQs, PQSRs
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    Computer & Equipment Validation

    • Part 11 Compliance Assessments, V-model & Testing
    • FATs, SATs, IOQs, TMs, VSRs, PQ & PQSRs
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    CQV Regulatory Guidelines

    • DAl EMA, ISPE
    • ASTM E2500
    • ISPE GAMP Guidelines
    • PDA and International Council for Harmonization

If it’s GxP, we’ve CQV’d it. Any process, any utility, any equipment, anytime

Commissioning, qualification, and validation are critical to project success; if they aren’t properly planned and executed, they can derail project timelines. Having delivered dozens of commercial launches—and 100+ capital projects in the last year alone—there is no modality, process, utility, equipment or health authority we don’t understand thoroughly. Put that unparalleled knowledge and experience to work for your CQV planning and development.

Our heritage: complex projects CQV’d around the world

As industry pioneers, Precision has a proven track record of planning, building, and maintaining manufacturing facilities, capital expansions and technical operations for novel modalities and complex biologics. We know what we are doing—including CQVs.

Commercialized cell, gene, and novel therapies
Life-science organizations partnered
Facility builds and expansions led
Tech ops partnerships

People first and patient-focused

Our greatest resource is our people, with patients at the core of everything we do. Commitment to that value provides a foundation of success for us and our partners.