WORLDWIDE GXP COMPLIANCE SERVICES & SOLUTIONS

We offer an integrated portfolio of Consultancy Services and Software Products for ensuring GxP compliance of business processes and resources, including facilities, utilities, equipment and IT.

Quality Management

  • Permanent Inspection Readiness
  • Build and improve Quality Management System
  • Sourcing of QA personnel

    • Qualification and Validation

  • Qualification and Validation (Computerized systems: IT and Equipment)
  • SAP/ERP Validation
  • Qualification and Validation of Utilities
  • Life Cycle Process Validation (LCPV)

    • Auditing & Assessment

  • GAP assessments
  • Heath Authority inspection / Notified Body audit services
  • Audit Services

    • Pharma 4.0

    Pharma 4.0, also called the smart factory, is a framework for adapting digital strategies to the unique context of pharmaceutical manufacturing.

    Data Integrity

  • Project management and governance
  • Assessment
  • Prioritization based on criticality
  • Remediation