Artifacts: Risk Management

Classification of data managed by the GxP computerized system, created by the Product Owner in conjunction with the System Owner and Development Team as required by the System Risk Assessment per SRD-0145688. Documented in iRAAM and must be approved before initial production release.

Risk assessment embedded in SOLMAN as field values on Process Steps (L5) and Processes (L4). Captures GxP relevance, Business Criticality, and Solution Type for each functional unit. Reviewed by Validation Lead as part of Work Package setup review.

A risk assessment deliverable that determines the technical risk level of each system function or component by applying risk parameters (implementation type, regulatory impact) using a risk matrix, guiding the test strategy.

An assessment of risks related to the retirement of a computerized system, performed and documented prior to commencing any retirement activities. Covers all planned retirement phases and includes open change requests and incidents.

A documented plan capturing the actions to mitigate identified risks for a computerised system. Executed under the accountability of the Process Owner, who must assure the plan is carried out; residual risk acceptance is documented by the Process Owner.

Assessment documenting risks to data integrity, retrievability, confidentiality, and record retention arising from system retirement, including impact on interfacing systems and retention of system documentation. May be standalone or incorporated into the System Retirement Plan.

Risk assessment document evaluating the compliance risk of a GxP computerised system and determining commensurate quality oversight measures. Must be maintained and available for health authority and internal audit review at all times.