Some system implementations are more complex (e.g., upstream and/or downstream systems providing data and/or transforming data, various modules included in a “system”). Depending on the size and complexity of the system and related data, there might be a requirement to build a Master Validation Plan (“validation wrapper document”) and then individual validation plans/protocols detailed to each system or module specific to that area. By forming that upfront GxP determination and Risk Assessment, you can break-down the specific scope of the system(s) and data. There might be a business rationale to have stricter validation controls in support of more regulated data based on how the system is setup. This initial validation planning and assessment phase is critical, as it helps to determine (and document) the basic assumptions and parameters for validation. This information and results or recommendations can be documented in stand-alone documents and then summarized and referred to in the Master Validation Plan or Validation Plan(s). Having this documented upfront, you can focus on stricter documentation and validation controls around the areas of a system or data which require more attention.
