GxP Systems Validation and Compliance

BKP Technologies, Inc. has extensive experience assisting life sciences clients with GxP computerized software systems validation (CSV) and regulatory compliance of computer systems. Whether the need is for computer system validation as part of a new system implementation (in-house or hosted/cloud), upgrading an existing system, assistance with the latest 21 CFR Part 11/EU Annex 11 or GxP requirements, or an audit of your existing systems and validation status – BKP provides professional services to benefit your organization.

Our Computer Systems Validation expertise includes modern and flexible:

  • Software/Systems Development Life Cycle (SDLC) Methodologies
  • Risk Assessments
  • 21 CFR 11 Compliance
  • EU Annex 11 Compliance
  • GxP Regulations and Guidance
  • ICH Compliance
  • Privacy Compliance of Computer Systems
    • HIPAA
    • GDPR
    • US State Privacy Regulations
  • Validation of in-house and hosted/cloud systems:
    • Pharmacovigilance/Safety systems
    • Clinical Data Management systems
    • Electronic Data Capture (EDC) systems
    • Coding Dictionary systems
  • Custom in-house application validation
  • Compliance of Software as a Service (SaaS) systems
  • Retrospective validation
  • Standard Operating Procedure (SOP) Authoring
  • Systems Compliance Audits
  • Vendor Audits

To learn more about our systems validation service offerings, download our Validation info sheet or contact us for a free consultation.