A practical model for strengthening GDP oversight, supplier control, escalation, governance and inspection-ready evidence around the RP role.
Use the operating model to move beyond having procedures in place. Each material GDP issue should leave a traceable chain from the requirement and evidence reviewed through to judgement, action and governance follow-up.
Define the GDP requirement, control signal, event or oversight question that needs RP attention.
Identify the records, trend data, supplier information and QMS evidence used to understand the position.
Record the RP judgement, escalation rationale, owner, action and expected completion or review point.
Confirm closure or effectiveness, identify recurring signals and make material issues visible through governance and inspection evidence.
Use the complete workspace, supporting guide and linked tools to structure implementation and evidence.
RegOpsPro™