Computer System Validation (CSV) Workflow

Start of the Workflow/Process.

Retrieve all User Requirements (URS) entries from the Requirements Data Model to initiate the validation scope.

Assign a task to the QA Lead to draft the Validation Plan based on the identified system scope.

Create a new entry in the Validation Plan data model containing the scope, strategy, and testing approach.

Assign a task to the Subject Matter Expert (SME) to perform a GAMP5-based risk assessment.

Create an entry in the Risk Management data model to document identified hazards and mitigation strategies.

Execute formula (Severity * Occurrence * Detectability) to determine the critical level of each risk.

Update the Risk Assessment entry to reflect that mitigation controls have been implemented.

Assign testing tasks to Validation Engineers to execute Installation, Operational, and Performance Qualifications.

Create a record in the Test Script data model for each protocol being executed.

Update the Test Script entry with pass/fail results and evidence links after execution.

Aggregate the number of 'Fail' statuses from all Test Script entries to determine total deviations.

Create a task for the Quality Engineer if the Deviation Count is greater than zero.

Create an entry in the Deviation Data Model for every failed test case identified.

Update the Deviation entries to 'Closed' once corrective actions are verified.

Create a report linking Requirements $\rightarrow$ Risks $\rightarrow$ Test Scripts to ensure full coverage.

Assign a task to the Quality Manager to review the final Validation Summary Report (VSR).

Create the final record in the Validation Summary data model summarizing the entire process outcome.

Send an email to the Project Sponsor and IT Department once the VSR is approved and the system is released for production.

Update the Computer System entry in the Inventory Data Model to 'Validated' status.

End of the Workflow/Process.