ent- GERC QUAL-QMS-GLOBAL-CH2800 02 of 12 Questions If a computerized system is determined to be GxP, but is deemed not to require validation, what the next step? O The rationale must be documented in the comments section of the GxP System Assessment Form O Documentation is required in the system design specification to justify decision, Create a Plan Deviation. Have the Quality Assurance Representative review rationale and approve, then document in Retirement Plan