Computer System Validation

Compliance with global regulations is an increasingly difficult hurdle for life sciences companies to clear
Technology: Validation

FMD K&L technology validation services enable organizations to comply with EU GMP Annex 11 guidelines while remaining focused on their core competencies. We offer a full suite of technology validation services enabling you to comply with regulations stipulated by international authorities, including FDA, EMA, MHRA, BfArM, and many others.

Services include:
  • On-demand technology validation
  • Integrated software development lifecycle (SDLC)/computer systems validation (CSV) project planning
  • Documentation & support for installation qualification (IQ), operational qualification (OQ) & performance qualification (PQ)
  • Risk-based test scenarios & test execution methodology
  • Change management & release management services
  • Audit preparedness & readiness services
  • Comprehensive validation strategy

We deploy our services through global delivery centers in the UK, India, and Philippines. Our ability to provide support through onshore, offshore, and hybrid models enables us to offer a predictable costing model across time zones. Our teams support applications ranging from drug safety systems to clinical data management, including web-based applications.

Companies that need to scale up quickly to meet short-term requirements during audit-preparedness, validation of new systems, or data migration can utilize our on-demand services augmented by a small team for the project duration.

We also provide a strong documentation framework to develop a library of information pertaining to the state of systems, strategies, testing, and reports for further analyses and reference.