When we approach validation we need to understand what we are here to do. Yes we are here to deliver a compliant functional system but bigger than this we need to create legacy. As a project is completed the system is handed over to operations and what occurs is a drop in performance and efficiency. The aim should be to smooth out this dip and make it into a plateau. By effectively communicating with the operations team we can ensure there is a skill and knowledge handover. Integration of the system is just as critical as the validation. This needs to be recognized at the early stages of the project and accounted for within the project plan so not to disrupt the validation plan in any way but still give the end user the time and access to the system.
Planning of a training structure into any major system installation should be developed front end. Some projects get this completely wrong and have operations teams assigned at the installation stage. This creates more problems than it solves. Inactive, under utilized teams can become demotivated. A better time to involve the operational team is once operational testing has commenced. This is where the end users input becomes invaluable. The end user doesn’t look how the system will be used in a test environment, there mandate is check the systems processes are repeatable on an industrial scale and so there perspective is different. The involvement at this stage can prevent the requirement for time consuming repetition work.
Collaboration in any project has to hit the right balance. Too much involvement can clutter the project and slow things down. Too little collaboration can result in a system validated for a sandbox environment but ineffective in a real world production environment. The key to striking this balance is planning at the front end of the project.