Supply chains in the life sciences industry are becoming increasingly complex. Many companies outsource parts of their production processes, logistics, or transportation to third-party Contract Manufacturing Organizations (CMOs). At the same time, rules and regulations for product and patient safety are getting more and more strict. Traceability software allows companies to gain and keep insight into their supply chains, while simultaneously demonstrating their compliance to international regulations, with a powerful search engine that uses unique codes to identify production or distribution batches.
Global Batch Traceability (GBT) software enables companies to analyze their supply chain in real time. By importing standard batch information provided by CMOs and other partners, the software compiles a transparent, easily-searchable database of the entire supply chain. Nowadays it is possible to import data from all types of sources into the GBT module, which increases usability and helps companies to stay in control of every step in the process.
This complete transparency is particularly useful in case of a recall. Not only does GBT simplify the process of identifying faulty products or batches, it can also show multiple batch genealogies in a single report. The flawed batch or product can be recalled before it reaches, and potentially harms, patients. Moreover, collaborations within the supply chain improve because knowledge gaps are diminished or even disappear completely. In this way, both patients and brands are protected.
Patient and brand protection
The added value of traceability software is most visible in complicated, multilayered production and logistical processes. For instance, in case of blood plasma that is used for the production of medicine. The semi-finished plasma, where plasma of a donor is used, is dispatched to numerous production facilities and to be used in a great variety of products. When an anomaly is discovered in the plasma, it is essential that the batch is recalled immediately. Without a totally transparent supply chain, the recall encompasses all batches in which the plasma might have been used, including those that turn out to have been unaffected. In a transparent chain, however, the products in which the plasma is used can be pinpointed exactly and withdrawn in a so-called ‘precision recall’.
Precision recalls diminish the financial damage of production errors. More importantly, the real-time analysis allows for the necessary action to be taken immediately and increases data integrity and patient safety. Traceability can also prevent negative publicity that may harm companies’ brand images. From a business point of view this is an important element.
Time to reporting to authorities
As mentioned, rules and regulations regarding the production of medication are increasingly strict. A large element of compliance is offering a fully transparent supply chain. With traceability software, patient and data integrity can be guaranteed more easily. GBT provides insights, efficiency, and safety in complex supply chains in the life sciences industry.