Validation Services

At CellSpark Consulting Inc., we help our partners establish structured, risk-based validation programs that are sustainable, inspection-ready, and fully aligned with regulatory expectations. Our approach is grounded in ICH Q8/Q9/Q10 principles, GAMP 5 guidance, and industry best practices such as ISPE Baseline Guides and ASTM E2500.

We support both greenfield operations and legacy remediation efforts, ensuring your validation program evolves with your product lifecycle, technology platforms, and compliance landscape.

Validation Master Planning & Lifecycle Strategy

  • Creation of audit-ready VMPs defining scope, strategy, and system classification
  • Includes validation deliverables, RACI matrix, acceptance criteria, and timelines
  • Ongoing reviews post-expansion, product launch, or process modifications
  • Validation strategy tailored using ICH Q9 and ASTM E2500 principles
  • QRM-aligned risk assessments defining validation depth and documentation scope
  • Design of governance structure with steering committees and review workflows
  • Cross-functional alignment across equipment, utilities, software, and processes
  • Traceability Matrices connecting URS to FAT/SAT, IQ/OQ/PQ, and summary outcomes
  • Consolidated Validation Summary Reports (VSRs) with test outcomes and deviations
  • Documentation structure optimized for regulatory review and audit defensibility
  • Requalification strategy based on system criticality, age, and performance history
  • Change control assessment to trigger partial or full revalidation as needed
  • Lifecycle file maintenance and updates integrated with CMMS and calibration systems
  • Alignment with GMP expectations for continuous compliance

Computer System Validation (CSV)

  • GAMP 5-based validation of software and digital systems (e.g., LIMS, QMS, ERP, PLC/SCADA)
  • 21 CFR Part 11 and Annex 11 compliance assessments
  • Validation documentation: URS, Risk Assessments, IQ/OQ, Data Integrity checks
  • Audit trail review and access control evaluations

Process Validation (PV)

  • Stage 1: Process Design support and risk assessments
  • Stage 2: Process Performance Qualification (PPQ) protocol development and execution
  • Stage 3: Continued Process Verification (CPV) and trending program design
  • Protocols aligned with FDA, EMA, Health Canada, and ICH Q8/Q9/Q10 expectations

Cleaning Validation (CV)

  • Cleaning process development and worst-case product/equipment selection
  • Cleaning validation protocols and swab/rinse method support
  • Hold time studies and cleaning verification
  • Continued cleaning process verification programs

Analytical Method Validation & Transfer

  • Method qualification/validation (accuracy, precision, specificity, LOD, LOQ, etc.)
  • ICH Q2(R2)-aligned protocols and reports
  • Analytical method transfer plans between internal sites or to CDMOs
  • Instrument qualification and lifecycle documentation

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