GXP Solutions | Computer System Validation (CSV)

What is a Computer System Validation (CSV) Audit?

Computer System Validation (CSV) audits assure that there is a process of providing documented evidence that a computer system or software performs exactly as intended, in a consistent and reproducible manner.

Purpose of CSV Auditing

All computerized systems in a GxP environment must be assessed for their impact on GCP, GLP/GCLP, GVP, and GMP operations. If impact is fond then these systems must meet ALCOA+ requirements for FDA 21 CFR part 11 and EU Annex 11 regulatory requirement by conducting a validated.

Types of CSV Auditing

FDA 21 CFR Part 11 / EU Annex 11 Compliance
Medical Devices
Change Control
Gap Analysis
QMS Projects
Inspection Readiness and Mock Inspection
Colocation/Data centers
Computer System Validation
- Electronic Data Capture Systems
- Imaging Systems/Platforms
- Learning Management Systems
- Interactive Response Technologies (IRTs)
  - Interactive Web Response Systems (IWRS)
  - Interactive Voice Response Systems (IVRS)
- Laboratory Information Management System (LIMS)
- Software as a Medical Device
- Software as a Service (SaaS)
- Platform as a service
- Laboratory Systems
- Electronic Quality Management Systems
- ePRO/eCOA
- Electronic Document Control Systems

Importance of CSV Auditing

Just because the equipment or software boasts compliance, does not guarantee that the purchased items meet the regulatory requirements or meet your company’s requirements for Computer System Validation (CSV).