FUE Qualification
Facilities, Utilities, and Equipment commissioning and qualification, aligned with GMP requirements and ISPE guidelines.
Four service pillars
Qualification, assurance, quality systems, and asset reliability support built around your project.
CoGenyx provides principal-led consulting across FUE qualification, CSV/CSA, quality systems support, and asset reliability and CMMS services.
Service structure
Four pillars aligned to your project.
The exact systems, responsibilities, deliverables, and review pathway are agreed with each client before work begins.
CSV/CSA
CSA-informed, risk-based computer system validation applied within applicable GxP requirements and the client’s quality system, informed by GAMP 5 and including assessment of 21 CFR Part 11 applicability.
Quality Systems Support
Deviation investigations and reports, CAPA development and closure support, and change-control support within the client’s quality system.
Asset Reliability & CMMS Services
Reliability engineering, maintenance program development, and CMMS implementation and validation.
Client governance: Engagement responsibilities are defined within the client’s quality system. Final risk acceptance, Quality approvals, and authorization for use or operation remain with the client’s designated personnel.
FUE qualification delivery
Support from scope and strategy through closeout.
Facilities, utilities, and equipment work can be scoped across the full commissioning and qualification lifecycle.
Scope and strategy
Define the systems and boundaries in scope, deliverables, roles, interfaces, schedule, and review path for the CQV work. Support requirements development and review design and vendor information so commissioning and qualification activities reflect the client’s approved project basis.
Commissioning
Support commissioning plans, vendor document review, readiness activities, field verification, punch-list coordination, and turnover preparation. Work is coordinated to the defined scope and handed off into qualification through the client’s established process.
Qualification
Develop and support execution of approved IQ, OQ, and PQ protocols, as applicable to the systems in scope and client procedures. Support documentation of results and discrepancies, coordinate follow-up, and prepare executed packages for client review.
Closeout
Reconcile protocols, traceability records, exceptions, punch items, and remaining actions. Prepare summary and turnover packages for client review, approval, and handover; final quality and operational-release decisions remain with the client’s authorized personnel.
Computer system validation
Risk-based computer system validation informed by Computer Software Assurance (CSA) principles.
CoGenyx supports computer system validation (CSV) for computerized systems used in biopharmaceutical and cell therapy manufacturing. CSA-informed critical thinking focuses assurance effort and retained evidence according to intended use and risk, particularly for functions that may affect manufacturing quality, patient safety, or data integrity.
Each engagement is defined within the client’s quality system and approved procedures. Typical activities can include:
Plan the assurance approach
- Define intended use and system boundaries
- Identify requirements and regulated functions
- Assess risk and criticality
- Agree roles, deliverables, and acceptance criteria
Test and close the record
- Select and execute testing proportionate to risk
- Record objective evidence, issues, and resolution
- Maintain requirements and risk traceability
- Prepare summaries for client review and approval
Applicability and client governance: FDA’s current CSA guidance is specifically scoped to production and quality management system software in the medical-device context. For biopharmaceutical and cell therapy engagements, CoGenyx applies relevant risk-based assurance principles within applicable GxP requirements, the client’s quality system, and approved procedures. This approach does not replace required validation, documentation, or approvals. The client retains final risk acceptance, system approval, and authorization for production use.
Quality systems support
Investigations and quality records grounded in how systems actually run.
CoGenyx supports deviation investigations and reports, CAPA development and closure support, and change-control activities for facilities, utilities, equipment, and the computerized systems that control them. Record-owner responsibilities are agreed when assigned by the client.
Typical support
- Deviation investigation planning, evidence review, and report authoring
- Root cause analysis and documented rationale
- CAPA development, action tracking, and closure support
- Change-control impact assessment, implementation coordination, and closure support, including record-owner responsibilities when assigned by the client
- Equipment and system impact assessment across qualification, maintenance, calibration, and validation records
- Record reconciliation and handoff for client review
Equipment failures often require both a quality-system record and a reliability response. CoGenyx connects deviation and CAPA work with equipment failure investigations, RCFA, maintenance strategy, and CMMS updates through Asset Reliability & CMMS Services.
Client responsibility: Quality-system ownership, document approval, final risk acceptance, and operational release remain with the client’s designated personnel.
Asset reliability and CMMS
Asset Reliability & CMMS Services
Qualification proves your equipment works. A reliability program keeps it that way. CoGenyx builds the maintenance, calibration, and asset management programs that keep your facility in a validated state and inspection-ready.
Early-phase teams often need fractional reliability engineering for biotech manufacturing and CMMS implementation for pharma operations before an inspection. As a CMMS consultant, CoGenyx can build the system and apply the same practical understanding during validation.
Reliability and CMMS scope
- Asset criticality assessments and risk-based maintenance strategy
- PM program development, job plans, and PM optimization
- CMMS selection, implementation, and master data build (Blue Mountain RAM, Maximo, SAP PM)
- CMMS validation using a risk-based, CSA-informed approach, aligned with GAMP 5 and 21 CFR Part 11
- Calibration program setup and scheduling
- Critical spares strategy and storeroom practices
- Reliability metrics, dashboards, and management reporting
- Equipment failure investigations, RCFA, and CAPA support
Maintenance and calibration records are GMP records. The CMMS operates under change control, and regulated functions such as audit trails and electronic signatures are assessed for 21 CFR Part 11.
Because CoGenyx also delivers CQV, asset data captured during commissioning flows directly into your CMMS. Your maintenance program is built alongside qualification, not bolted on afterward.
The same principal can implement and validate the CMMS, keeping asset management under GMP connected to the qualification basis without handing the work between separate vendors.
Equipment failure investigations and CAPAs can also require deviation reports, corrective actions, and change controls. CoGenyx connects that work through Quality Systems Support.
Client responsibility: Quality-system ownership, document approval, final risk acceptance, and operational release remain with the client’s designated personnel.
Ways to engage
The right level of support for the work.
CoGenyx can take on a defined package, add capacity to an established project team, or address a targeted documentation need.
Defined work packages
Agree to scope, interfaces, deliverables, schedule, and acceptance path for a bounded body of work.
Project-team augmentation
Add specialized capacity that works within the project’s governance, procedures, priorities, and reporting structure.
Targeted documentation support
Address a defined protocol, traceability, exception, summary, or turnover documentation need.
Roles and responsibility
Clear ownership from the start.
CoGenyx supports the agreed service scope. The client retains ownership of its quality system, final risk decisions, approvals, and release to operation.
Typical project inputs
- Approved plans and procedures
- Design and vendor information
- Project schedule and priorities
- Client review requirements
Typical consulting outputs
- Agreed deliverables
- Visible status and open items
- Reconciled project records
- Packages for client approval
Discuss your project
Start with the scope, schedule, and support you need.
Tell us where the project stands and which service responsibilities you are considering.
Share a high-level project overview through the inquiry form.