Validation plan risk management

Validation Planning Supplier Audit Risk Management... 

Conversely, if the supplier s Quality Management System is very well written and there is documented evidence that the supplier adheres to it, the definition of risk levels might be relaxed a bit in the Function Risk Assessment. If the supplier s own acceptance testing is well documented and thorough, the Validation Plan should document the intent to reference some of the supplier testing in lieu of internal tests. It is not necessary to specify exact tests to be used at this point that can wait until the test plans are being prepared later on. 

In general, the DIR is adequate if the design verification and validation test plans can be written and risk-management activities can be completed. Hence, if the product was developed exactly as described in the DIR, the overall residual risk would be acceptable. 

The documents described, namely, System Qualification Procedures (SQPs) and Standard Operating Procedure (SOP) in Figure 1 contain a generic risk assessment for determination of the validation scope and effort on the equipment lyophilizer. They were also used as a generic validation master plan for the project. Management of the project resources, costs, and deadlines was performed with a model created in a standard project planner. 

V V methods include inspection, analysis, demonstration, and validation and verification. V V activities are determined by the perceived risks, safety, and criticality of the element under consideration. Use of a requirements management tool is essential once a design has been established and V V begins. A unique requirements identifier can be used for traceability to the V V plans, procedures, and reports to provide a closed-loop process from system capability, as proven through a V V process back to the source requirement. Basic V V activities are as follows ... 

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