May 13, 2012

Systems Validation

 

BKP Technologies, Inc. has extensive experience assisting life sciences clients with  computerized software systems validation (CSV). 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 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
  • 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
  • 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.