CSA Governance Structure

 Layers 

What CSV did or does?

What CSA intends or can do?

Strategic

Level of rigor independent of systems classification or GxP categorization.

Procedure level and Behavioural level changes for systems classification based on risk-assessment.

Tactical

SOP’s, Work Aids, Guidance similar in implementation efforts irrespective of system design or quality design criteria.

Redoing SOP’s, Work Aids, Guidance for aligning with the Governance framework with optimized methodology.

Operational

Teams follow set-defined rules for validation without critical thinking leaving less room for reducing validation efforts.

Teams to be trained on risk-assessment, newer methods of system classification and made to understand the streamlined validation approach.