Initially all deliverables begin with the production of plans to scope the work required to design, develop and implement the application. As part of the planning function resource availability, effort and calendar time are determined for all validation activities. This is also the best time to negotiate with key decision makers for pertinent resources, meetings and needed feedback, so that a baseline plan can be established with validation activities and milestones.      Remember, a plan is not a plan unless agreed to by those with decision making authority; so spend time preparing for this negotiation, basing points and issues on facts, being as specific as possible.      The demands of the product, its characteristics, features and use, will also help determine the amount of effort and time needed to perform validation.      When planning for software validation, remember that effort and time may not necessarily translate equitable with one another.      For instance, documentation may comprise 28% of the total effort but requires only 13% of total calendar time to complete. Such variations in effort and time required to perform validation activities can be attributed to software related issues or resource availability. So make allowances for known blackout periods when resources or events will affect the timeline.      Allowances for such variations must be make for all five functions of validation.