Quality & Compliance Services

Click here for the Deviaton-NC-CAPA Cut Sheet.

At CellSpark Consulting, we bring extensive experience in Quality and Compliance to support your advanced therapy product development, manufacturing, and commercialization. Our experts ensure your operations meet global regulatory expectations while building a culture of quality and continuous improvement.

Quality Management System (QMS) Development

  • Quality Manual, Policies, SOPs, and Work Instructions
  • Document control systems and training programs
  • Controlled templates for deviation, CAPA, change control, etc.
  • QMS dashboards and KPIs for performance tracking

Deviation, Nonconformance & CAPA Management

  • Deviation/NC Investigation Support
  • CAPA Management
  • Systemic Gap Identification
  • Effectiveness Check & Verification

Quality Operations

  • Batch record review and release readiness
  • Review of quality agreements and technical documentation
  • Integration of digital quality systems

Supplier and Vendor Qualification

  • Supplier Risk Assessments and Audits
  • Qualification Plans and Approved Vendor Lists (AVL)
  • Quality Agreements
  • Periodic Requalification and Monitoring

Audit, Inspection, & Regulatory Readiness

  • Internal and External Audits
  • Mock Regulatory Inspections (FDA, EMA, MHRA, Health Canada)
  • Pre-Approval Inspection (PAI) Support
  • Audit Response and CAPA Closure

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