Once the plan’s baseline has been set, objectives established and resources allocated, documentation must be developed for the application, defining the software’s requirements and specifications. All documentation must follow a similar approach to its production, review, refinement and approval, assuring the consistency, accuracy, quality and quantity of the information provided. This includes ensuring that all standards, structures and templates are used consistently (i.e. document structure standard and user requirement templates).      All documentation should be assessed for gaps between the intended design and functional application of the software. Assessing for gaps help identify hazards that the end user may encounter when using the product; hazards that much be addressed by documentation in the form of requirements, specifications, user guides, standard operating procedures, training materials, etc. This wide variety of documents must be maintained throughout the life of the product.      When producing documentation the end user must be intimately involved to help assure a complete and accurate interpretation of their needs throughout the life of the software. Consistent communication in the form of document reviews helps keep documentation true to the intended use of the application.      The validation effort, the subjects requiring validation and their effect on the consumer and business will ultimately determine the breadth of documents that must be produced; both in variety and quantity.