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 Computer Systems Validation team brings 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.