CSA Governance Structure

Impact of layers of Governance

Does our understanding meet your thinking?


What CSV did or does?

What CSA intends or can do?


Level of rigor independent of systems classification or GxP categorization.

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


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.


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.

Valina Services

SINGAPORE (048616)

Validation services

© 2021 Valina Services. All rights reserved.