A system designed to digitally manage and document the entire manufacturing process for a specific batch of product. It replaces traditional paper-based records, offering a structured method to capture data related to materials, equipment, personnel, and procedures at each stage of production. For example, in pharmaceutical manufacturing, it tracks everything from raw material weighing to final product release, ensuring a complete and auditable trail.
The adoption of this type of system yields significant advantages. It streamlines operations, reduces errors associated with manual data entry, and enhances data integrity. Real-time data visibility facilitates faster decision-making and improved process control. Historically, these systems emerged as a response to the need for greater efficiency and regulatory compliance within industries like pharmaceuticals and food processing. Their implementation reduces the risk of non-compliance and facilitates easier audits.
