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Validation Services

From Commissioning to Compliance—We Validate Your Success.
  • Integrated design and project management approach for efficiency and compliance.
  • Expertise in pharmaceutical and biopharmaceutical facility planning aligned with global GMP standards.
  • Proven track record of delivering projects on time with audit-ready documentation.

Our C&Q Services Include

Commissioning and Qualification

  • End-to-end verification of systems, utilities, and equipment installations.
  • Execution of FAT, SAT, installation checks, functional testing, loop checks, and documentation to ensure systems are ready for qualification.

Qualification, Documentation & Compliance

  • Risk-based approach focusing efforts on critical systems impacting product quality and patient safety.
  • Development and review of URS, VMP, Risk Assessments, Design Documents, FAT/SAT Protocols, IQ/OQ/PQ Protocols, Traceability Matrix and Reports aligned with industry best practices.
  • Design Qualification (DQ) – Verification that the system design meets URS, GMP, and regulatory requirements.
  • Installation Qualification (IQ) – Confirmation that equipment and utilities are installed as per approved specifications and drawings.
  • Operational Qualification (OQ) – Testing of all functions, alarms, and interlocks to ensure proper operation under defined conditions.
  • Performance Qualification (PQ) – Demonstration of consistent performance during actual operating conditions.

Our CSV Service Offerings

Risk-Based Validation Approach

  • Conduct risk assessments to identify GxP impact systems and define validation scope.
  • Categorization of systems as per GAMP 5 software categories (Infrastructure, Non-configurable, Configurable, Bespoke).

Validation Lifecycle Services, Documentation and Compliance

  • Development and review of URS, FS, Vendor Assessment and Audit, VMP, Risk Assessment, IQ/OQ/PQ Protocols & Reports, Traceability Matrix, 21 CFR Part 11 Compliance Assessment.
  • User Requirement Specification (URS) & Functional Specification (FS) Development
  • Vendor Assessment & Audit (including 21 CFR Part 11 readiness)
  • Validation Planning: Preparation of Validation Master Plan (VMP) and project-specific validation strategy.
  • Testing & Documentation:
    Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
  • Traceability Matrix & Data Integrity Assessment to ensure regulatory compliance.

Periodic Review & Change Control

  • Support for system periodic reviews, re-validation, and change management.
  • Guidance on maintaining data integrity throughout the system lifecycle.

In addition, we also offer Cleaning Validation, Analytical Method Validation, Process Validation, and Vendor and Material Qualification Services.