Computer Systems Validation (CSV)

Organizations that are implementing regulated computerized systems need to ensure they are suitable for use and compliant with legislation and internal policies.

Our CSV team bring a thorough knowledge of global regulatory requirements and technology expertise to ensure an audit-ready validation package for implementation of regulated systems. Our capabilities include:

  • Conducting regulatory, risk and impact assessments.
  • Creating validation strategies to align with regulatory requirements, corporate methodologies and business needs.
  • Drafting and maintaining traceability matrices.
  • Designing and documenting test scripts to ensure appropriate levels of evidence and rigor.
  • Executing tests and documenting defects and observations.
  • Coordinating acceptance testing.
  • Documenting validation summary reports.