What are the deliverables as per GAMP5 guidelines?

Question

Accepted Answer

Deliverables as per GAMP5 guidelines include validation plan, user requirements specification, functional specification, test protocols, and validation report.

Validation plan outlines the approach, resources, and schedule for validation activities.
User requirements specification details the functional and non-functional requirements of the system.
Functional specification describes how the system will meet the user requirements.
Test protocols outline the tests to be performed to ensure the system meets the requirements.
Validation report summarizes the validation activities and results.

What are the deliverables as per GAMP5 guidelines?

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