The implementation of an Electronic Batch Record (EBR) solution makes it possible to ensure that operations are carried out consistently following the best practices and with the best quality, allowing continuous improvement and Right First Time to be implemented in the company.
The EBR system ensures that manufacturing processes are performed efficiently by consolidating and optimizing the various manufacturing resources available, including equipment, people, processes, and products.
The digitization of the weighing and fractionation systems (Weighing and dispensing) allow guiding operators to streamline operations, reducing errors and risks of contamination, as well as ensuring the traceability of all actions carried out in the weighing area.
They also allow the optimization of material flows, ensuring that the necessary amounts of material will be available at the correct work station and at the right time, optimizing the use of available resources to improve the efficiency of operations.
The traceability of the product batches allows the identification of the different batches of materials that have been used to manufacture each batch of product and which batches of the final product have been manufactured from a batch of raw material. This information is key to ensure traceability of manufacturing batches and is a requirement of Good Manufacturing Practices (GMP).
Digital genealogy and traceability solutions allow us to quickly and graphically identify which product batches are affected by a raw material quality defect and in the case of a drug withdrawal from the market (Recall), it allows us to identify the batches of raw material that could be affected and even control that other batches of final product could have been manufactured with those batches of raw material.
PAT technology (Process Analitycal Technology) and the use of AI (Artificial Intelligence) allow reducing Time To Market.
Manufacturing gains flexibility and a better understanding of processes, enabling faster response to changing market needs.
The use of PAT allows the reduction of quality costs, by bringing quality control closer to the production line (in-line, on-line, at-line), away from quality laboratories.
The use of PAT and AI results in operational excellence and performance improvement, when applied across the entire continuous manufacturing production line.