ZERO Prostate Cancer Walk/Run, NJ 2024
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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.
Validation Program Development
- Policies and standard operating procedures
- In-class room training
- Qualification and certification
- Life-cycle validation
- Methodologies
Process Validation
- Master batch records process
- Performance qualification
- Process performance
- Qualification summary reports
Validation Maintenance
- Periodic review and validation maintenance plan
- Re-qualification protocols
- Validation maintenance summary reports
Laboratory Validation
- Part-11 Compliance Assessments & Testing
- Commercial Off-The-Shelf (COTS) Qualification
- Method Validation
Commissioning & Qualification Lead
- Validation Master Plan
C&Q Plan - Risk Assessments & Leveraged commissioning (e.g. ASTM E2500)
- Vendor Audits Engineering & Validation Document Approval
- Validation Master Plan
Steaming Validation
- Steaming Validation Strategy & Master Plan Cycle Development
- IOQs, PQs, PQSRs
Cleaning Validation
- Cleaning Validation Strategy & Master Plan
- Cycle Development DHT & CHT
- IOQs, PQs, PQSRs
Computer & Equipment Validation
- Part 11 Compliance Assessments, V-model & Testing
- FATs, SATs, IOQs, TMs, VSRs, PQ & PQSRs
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.
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.
ZERO Prostate Cancer Walk/Run, NJ 2024
St. Jude Walk/Run, PA 2024
