A comprehensive documentation of all activities, events, and conditions involved in the production of a specific quantity of material. This documentation captures details from raw material input to finished goods output. For example, it includes information like the precise quantities of each ingredient used, the equipment employed, the environmental conditions during processing, the analytical test results obtained at various stages, and any deviations from established procedures.
The meticulous nature of this documentation ensures product traceability, facilitates efficient investigations into deviations, and supports consistent product quality. Maintaining such records is crucial for regulatory compliance across industries such as pharmaceuticals, food and beverage, and chemicals. Historically, these records have evolved from paper-based systems to increasingly sophisticated electronic formats, enhancing accessibility and data integrity.
