Computer System Validation (CSV)

We are highly experienced in both compliance and project management. This enables us to ensure that computerized systems are compliant at all levels – and that compliance processes are run efficiently. With decades of specialized life science industry experience, we’re here to help you with various sSV Services, including: 

  • Quality Management System(s)
  • Risk assessments
  • Software vendor audits
  • Vendor assurance
  • GMP compliance (mock) audits
  • Qualification/validation services
  • Compliance strategy development
  • 21 CFR Part 11/Annex 11 compliance and IT validation
  • Standard Operating Procedure (SOP) authoring and review 

PLG, providing confidence in IT compliance

We are specialists in navigating technical IT and regulatory challenges within the pharma, biotech, and medical device industries. Our consultants hold decades of experience and have training and certifications in CISSP, CISA, GDPR, CISM, ISO 27001, EU Annex 11, GAMP, FDA 21 CFR 11, and more. When you work with us, you gain access to their expertise to help you answer tough questions and ensure your IT systems are compliant and future-ready! 

This SaaS solution is really all you need to test software in a regulated industry.

Søren Winkel

Partner and Managing Director (Pharma IT), ProductLife Group

Søren Winkel