ABSTRACT
The validation philosophy, defined by management, creates a workable environment for employees. It is the critical first step in organizing for validation and assumes that management is knowledgeable and will be accountable to regulatory agencies. The personnel involved in the organizing process must be properly educated and managed over an extended period of time. The Food and Drug Administration interprets “a specific process” to include facilities/ utilities, sterile processes, pharmaceutical-chemical processes, pharmaceutical processes, biopharmaceutical processes, medical devices, cleaning, production and laboratory equipment, computers/software and analytical methods. Create a library of validation information, organized in time order with the most recent information in front. Virtually all industry clinical trials are statistically designed experiments—the most scientific, efficient and economical way to collect data. Separate the validation process and documentation from other agendas and programs. The real business benefit of validation comes from synergy with all other activities, systems and programs.
