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.