Computer System Validation often shortened as "CSV", concerns data processing systems are used as part of production or the quality system (from FDA QSR 820.70) or, as freely interpreted from ISO 13485:2016, all computerized systems being used in any of the processes regulated by the Quality Management System.
In its most basic form, a CSV plan should state the User Requirements, which captures the intended use of the systems. The User Requirements are then tested in IQ, OQ, and PQs, and the results of these tests and, if applicable, deviations are summarized in the Validation Report.
These kinds of tasks are easily performed in an ALM like Aligned Elements.
The Aligned Elements CSV Configuration
This lightweight configuration contains the basic elements for documenting the validation of a computer system.
It includes:
- Design Controls for User Requirements and Design Specifications
- Design Controls for Test Cases and Test Results
- Optional Design Controls for Risk Assessments
- Predefined Trace Tables
- Document Template examples for Validation Plans and Validation Reports
- Document Template examples for IQ, OQ, PQ Plan and Report
